Dimetrix limited dxb - bio tech

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DXB Close to Phase 2 Results: Progresses Promising CKD Product

http://www.nextbiotech.com.au/dxb-close-phase-2-results-progresses-promising-ckd-product/

Dimerix (ASX:DXB) has just completed its “pre-IND” consultation with US regulatory body the Food and Drug Administration (FDA) with some encouraging outcomes reported.

The big news for DXB is that its intended Phase 3 DMX-200 trial will be positioned as an adjunct therapy and not a fixed dose combination therapy.

In other words, DXB’s DMX-200 trial will be completed by adding one drug to patients on the existing standard of care. Many patients are already taking an angiotensin II type I receptor blocker, which is registered in the US for treatment of high blood pressure and diabetic nephropathy, a disease of the kidney, and the trial will add a chemokine receptor CCR2 blocker, used for its anti-inflammatory properties, to this routine treatment.

This confirmation is a key development for DXB — not only could this significantly de-risk the DMX-200 trial, but equally importantly, will drastically reduce the time, effort and cost required to progress DMX-200 through to final approval and end-user sales.

Remember, however, that this is still an early stage biotech company and anything can happen, so remain cautious when considering adding this stock to your portfolio and seek professional financial advice.

All in all, DXB’s ambitions have been well and truly validated by the FDA which now leaves DXB with a smoother and less fraught development path. A key caveat for DXB is that “substantial further investment should not be required before filing the Investigational New Drug application (IND) for the first US study, known as the PK study”. When a budding young company is told it doesn’t require substantial additional funding, that tends to be a good measure of progress.
Stage 2 results are also imminent for DXB — currently expected around October 2016 at the latest.

In terms of R&D, it’s so far, so good for DXB:

Investor Update

With research and development neatly taken care of, further validation comes in the form of the Novartis Prize — an annual award by the British Pharmacological Society which has recognised DXB’s Chief Scientific Officer for his work on DMX-200.

This multi-award winning molecular pharmacologist has been recognised by academia which is superb for the academic sciences…
…but it’s the recognition from DXB’s Board that could make all the difference for DXB investors, and chronic kidney disease sufferers.

With Professor Pfleger as DXB’s Chief Scientific Advisor, and positive progression of its clinical programs, means DXB’s underlying discovery engine can be further developed to generate new opportunities.

With all that and more (including a new DMX-250 variant that will focus on treating Non-Alcoholic Steatohepatitis (NASH)) we’re back to re-sync our readers with DXB’s story — a budding early-stage pharma company aiming to become a rapid biotech growth story that leverages modern lifestyles.

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10 Reasons to love DXB:

1. US patent allowance: covers all ARBs and CCR2 antagonists! This is huge in itself.. Watch out Chemocentryx...

2. Ph2 trial recruiting well now. June update - 11 patients recruited and counting. Accelerating recruitment suggests engaged clinical investigators who are happy with current safety profile and possibly efficacy of the drug combination.

3. TGA Special Access Scheme granted! Again- very positive- two different clinical investigators at two of the trial sites applied to have their patients continue on PPG after the trial finished.. Now why would they do that?? Well- they only would if they thought it would be safe.. (primary outcome of trial) and if they saw that it worked (ie reduced proteinuria, secondary outcome of trial)! This I believe is the best indicator of positive trial results due soon.

4. Ph2 interim data- due out in less than 2 months, reiterated by the Company many times..Patients that will be included in the analysis have already been recruited so they know exactly when the results will be available.. Could be out sooner... within a month??

5. Extended release PPG being formulated.. Increases clinical acceptance and commercial value upon approval.

6. Orphan Drug designation!! Not many Australian companies have an orphan drug designation from the FDA! Financial assistance available, increased interactions and guidance from the FDA, smaller trials required and market exclusivity for 7 years! Only a single Ph3 trial <100 patients required! Most non-orphan indications will require two Ph3 studies each of around 400-500 patients each.

7. $2M in cash- no need to raise capital now.

8. Second indication: NASH - massive market and growing as humans grow horizontally too. Positive pre-clinical studies!

9. Platform technology- other indications being evaluated.. more to come!!

...and the best part..

10. Enterprise value ONLY~$11 million!! (MC ~$13M).



"What's DXB worth with positive interim Ph2 data and an Orphan drug designation, solid IP position and a proven platform technology... ??? Conservatively $50-60M (or 3.5-4.0c)"

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THIS article came out yesterday- James Williams knows how to make money and he is at the helm of DXB :)

James Williams' investors have made millions and now the focus is on whether he can do it again


He's built a reputation for generating outsized returns for early stage investors in biotech companies. And now that James Williams is at the helm of his own publicly listed biotech, the pressure is on to see if that success can be replicated.

There was the 10-fold return from selling iCeutica for $60 million, a company that had developed a platform for reformatting existing drugs with improved clinical outcomes along with earlier deals such as with Ferriscan and the sale of an artificial cornea.

But the key to generating outsized returns is getting the science right.

"Without the science and clinical outcomes, there is no deal," Dr Williams says of the way to profit from the biotech sector. "It's all about getting the early development right and getting the capital lined up.

"Financial returns are driven by quality outcomes. It is not prudent to promote towards financial returns without having the outcomes. Our investors aren't investing philanthropically."

With both the artificial cornea and Ferriscan, which measures the concentration of iron in the liver and which was sold into Resonance Health, he played a key role in finalising product development and winning the necessary government approvals to market the products locally and abroad, garnering most of the product value, before they were then onsold.

Now Dr Williams is at the helm of Dimerix, a backdoor listing that has acquired DMX-2000, a potential treatment for chronic kidney disease together with its underlying drug delivery platform.

Independent biotech analyst Stuart Roberts of NDF Research reckons DMX-200 could progress quickly through clinical trials.

"The actual drug could be game-changing in kidney disease given the lack of new drugs in this space and the fact that around 12 per cent of the US adult population has some sort of chronic kidney disease," he said in a recent research note.

And there is also potential for upside from its drug development platform especially since there have already been two big deals for Receptos and Heptares which are both active in the same field of research – receptor molecules known as G protein-coupled receptors. Celgene paid $US7.2 billion for Receptos, for example, underscoring the potential value of companies that also control their underlying development platform.

The indications are that DMX-200 can reduce the protein content of urine, which is potentially useful in treating some kidney disorders but it is still only at the early stage of development. Australian biotech companies are often taken public too early, due to a lack of venture capital funding for early stage research. With iCeutica, for example, Dr Williams had to go to the east coast of the US to raise the money.

"Getting money in this space is difficult. There is a shortage of venture capital in the private space. Once you're public it is easier to get money, but you then become a slave to markets. There are only one or two funds available for preclinical work."

His work to get Dimerix off the ground comes as he is also pitching to the federal government to manage part of its planned biotech investment fund.

"Rather than one major fund manager handling the bucket of money, you need several fund managers running a portfolio approach," he said. "You try to get diversity across the portfolio, which can mean that some promising technologies in the same field could miss out, so you need several funds which could take up those other opportunities.

"Not all fund managers seen things the same way, for example a large fund can invest in 10-20 plays and hopefully three or four will work. But smaller funds have fewer investment options.

"Diversity of fund managers means a diversity of philosophies across the portfolio. So it is essential the government goes down the path of using several fund managers."


Source:

http://www.smh.com.au/business/jame...ether-he-can-do-it-again-20160901-gr6ckj.html

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People - looks like this is about to run - phase II results due any day now and buyers building - could be a BIG run

What's DXB worth with positive interim Ph2 data and an Orphan drug designation, solid IP position and a proven platform technology... ??? Conservatively $50-60M (or 3.5-4.0c)"

GLTA

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People - looks like this is about to run - phase II results due any day now and buyers building - could be a BIG run

What's DXB worth with positive interim Ph2 data and an Orphan drug designation, solid IP position and a proven platform technology... ??? Conservatively $50-60M (or 3.5-4.0c)"

GLTA

there you go 1.1c taken out so if we break 1.3c its blue sky territory and coupled with positive result should see it run to recommendation report of 4c -5c giving us a 400%- 500% return - well based on my entry price of 1.1c

http://dimerix.com/wp-content/uploads/2016-08-25-Dimerix-report-from-NDF-FINAL.pdf

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Update ....

"The trial has two parts. Part A is a dose escalation trial recruiting up to 30 patients." these results due this month

http://www.proactiveinvestors.com.a...onic-kidney-disease-clinical-trial-69053.html

Biotechnology company Dimerix Bioscience Ltd’s (ASX:DXB) has dosed 10 patients in an open label Phase II trial of its novel combination therapy DMX 200 for adult patients with chronic kidney disease (CKD).

DMX-200 combines two existing drugs, irbesartan and propagermanium.

Irbesartan is an off-patent angiotensin II type I receptor blocker indicated for the treatment of hypertension and nephropathy in Type II diabetic patients.

While propagermanium (PPG) is a chemokine receptor (CCR2) blocker, which has been used for the treatment of Hepatitis B in Japan and is available in the USA for its anti-inflammatory properties.

DMX-200 has been shown to improve the outcome of chronic kidney disease by reducing proteinuria by more than 50 per cent in animal models.

The primary end points of the trial are the incidence and severity of adverse events and the clinically significant changes in the safety profile of participants.

The secondary end points are obtained from statistical analysis of biomarker data at each time point including change from baseline.

In addition, it is the proportion of responders defined as those participants achieving normalisation of proteinuria (proteinuria within normal limits) or those participants achieving a 50 per cent reduction in proteinuria.

The trial has two parts. Part A is a dose escalation trial recruiting up to 30 patients. All patients recruited to the trial will be on stable irbesartan therapy, and will be treated with propagermanium dosed orally three times per day.

In total 11 patients have been dosed and the first two patients recruited have completed the dose escalation stage.

The investigators will escalate the patients’ dose to 60, 90, 150 and 240mg per day over each four week period.

Dimerix is on track to provide an interim data analysis based on 10 to 15 patients in the trial before the end of Q3 2016.

Proteinuria is common in CKD patients and is a strong independent risk factor for disease progression.

The Australian Research Council, an Australian Government entity, had recently awarded a $499,000 Linkage Grant to a consortium that includes Dimerix.

The grant will be paid over three years and will expedite the development of Dimerix’s proprietary screening assay.

The company is well funded with a cash balance of $2.4 million as on 31 March 2016.

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Massive volume starting to going through now - is suspect trial results leaning towards medical breakthrough - as always time will tell

Independant valuation was around 4c :)

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Getting close to announcement now - expected this week and may be a massive game changer -
heres some info on DXB for those NOT UP TO PLAY
GLTA Holders

exciting times and great management - possibly best in business

Investors and people curious about DXB and considering investment, heres a quick overview - We are waiting for DMX-200 results
This is to add or supplement other posters information -

We must be getting very close to results now- as we only have approx. 8 trading days before end of September AND results to be reported to market in Q3 2016 - Could be any day now and if its shown to be safe and highly efficient we are on a winner and whats exciting about that is that we could eventually enter the Orphan Pathway- which essentially enables much shorter trials and less patents required meaning less money etc...

A quick snapshot about DXB !!

Whats the opportunity
Chronic Kidney Disease (CKD) – the big opportunity
• A global unmet medical need leading to kidney failure, cardiovascular disease and premature death
• Estimated 26 million people in the US
• Estimated US$2.6 billion spent in the US each year, mainly on late stage therapies due to lack of early stage treatment options
The Orphan Pathway
• Enables shorter trials with fewer patients and cost benefits
• Registration brings seven years of exclusivity in the US market

Here is the presentation
http://dimerix.com/wp-content/uploads/Dimerix-Corporate-Presentation-August2016-FINAL.pdf

Current Phase 2 POC – Part A
• Treatment of proteinuria in chronic kidney disease (CKD) patients taking irbesartan
• Dose escalation to show safety and inform best dose of propagermanium
• Recruitment on target
• Initial safety and efficacy data to be reported Q3 2016

DMX-200 – Path to Registration for FSGS
US Investigation New Drug (IND) application
• Initial pharmakokinetic (PK) study
• Comparison of current three times daily version with extended release formulation
Phase 3 Development for FSGS – FDA Pre-IND meeting outcomes:
• Agreed development as a adjunct (not combination) therapy
• Primary endpoint discussions positive:
“A substantial change in proteinuria in patients with marked proteinuria
at baseline may be an acceptable endpoint for traditional or accelerated
approval…”


WHAT ELSE IS DXB WORKING ON ?

DMX-250
– NASH 10 The opportunity • Non–Alcoholic Steatohepatitis (NASH) is a serious unmet medical need • Estimated 6 million people in the USA alone • Increasing incidence due to increasing obesity, diabetes and metabolic diseases • Estimated global market size by 2020: >US$1 billion

DMX-250 – Why Liver?
DMX-250
• Both the Angiotensin Receptor and the Chemokine 2 Receptor associated with liver
disease
• Builds on the knowledge from DMX-200 of the CCR2 antagonist propagermanium
• Investigating Angiotensin Receptor Blockers other than irbesartan for commercial
differentiation


Patents
Good to see Kathy Harrison (General Manager) is also a Registered Patent and Trade Mark Attorney which bodes well for us -

Management Team - the calibre is OUTSTANDING
Experienced board and management Executive Chairman: Dr James Williams BSc(Hons), PhD, MBA, GAICD
• 15 years experience starting, funding, running and exiting biotechnology companies
• Co-founder of Dimerix and iCeutica (acquired in 2011 and now with 3 FDA drug approvals)
• Co-founder and Investment Director of Yuuwa Capital ($40M venture capital fund)

Director: Dr Sonia Poli MSc, PhD • Former Senior Management at Hoffman la Roche and Executive at Addex Therapeutics (Switzerland)
• 20 years international experience in small molecule drug design, optimization and clinical development
• Expertise encompassing multiple therapeutic areas.

Director: Dr Liz Jazwinska PhD, MBA, GAICD
• 25 years experience in R&D management and drug portfolio business development
• Led Asia Pacific Partnering Group at Johnson and Johnson Research
• Director Industry Engagement at Institute of Medical Biology, A*STAR,
Singapore Director: Mr David Franklyn BEcon
• Experienced Director of ASX-listed companies in a variety of sectors
• Extensive experience in financial analysis, corporate advice, business management and IR
• Managing Director of Village National Holdings Limited
General Manager: Ms Kathy Harrison MSc, Cert.Gov.(Prac), FIPTA
• 20 years experience in Biotech: AMRAD, Cytopia Research Pty Ltd, Phosphagenics Limited
• Registered Patent and Trademark Attorney

Exciting times for a massive re-rate in relation to our peers at stage 2 and 3 trials who are way above our small market cap


GLTA G101

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Guys this is exciting and announcement on stage 11 trials due this week - from another site POTENTIAL VERY SOON FOR THIS TO FLY -price target is 4c post trials due end of September :) ( Currently 1.5c ) from latest NDF RESEARCH DYOR

"We value Dimerix at 2.4 cents per share base case and 5.9 cents per share optimistic case.
Our target price of 4.0 cents per share sits at the midpoint of our DCF range." currently 1.5c so potential 200-300% short term gain

http://dimerix.com/wp-content/uploads/2016_08_25_dimerix_report_from_ndf.pdf

People this is a post from Ahmed HC - a few weeks ago ....
Certainly is getting very interesting. There are only two companies with an orphan drug designation for FSGS- Dimerix (A$25M Mcap) and Retrophin (>A$1Bn Mcap). Should DMX-200 "pass with flying colours" and therein validate the Receptor-HIT platform (although any significant reduction on proteinuria beyond irbersartan alone I feel validates the technology, flying colours or otherwise), then we are talking a serious valuation. The FSGS market is >$1Bn in the US alone. Orphan status (with 7 years exclusivity) means .... well, it means the company will probably get taken out after pivotal data. The value would have to be between US$0.5-1.0Bn I imagine with a significant upfront and decent milestones and royalties to follow; dependent on when that would occur. And should the technology platform therefore also pass with flying colours and produce more targets.. well- you've got a medium-sized biotech now. Again, very likely to be acquired by Pharma well in advance of this. To extract full value at that stage, we would have to be listed on the Nasdaq I believe. So I'd think somewhere between $0.50 to $1.00 conservatively should this occur.. Even with DMX-200, if proteinuria reduction can be safely shown to occur with the combination in excess of IRB alone, then we have a useful drug that is applicable to the broader CKD market. Although clinical trials to show this would have to be quite large and expensive, a pharma partner I think would find it very attractive to in-license. S0- orphan drug designation for FSGS or not, if DMX-200 shows decent proteinuria reduction (I'm looking for 20-25% reduction in this study) then I believe we have some very valuable. As a nephrologist friend of mine recently commented to me in general.. "any reduction in proteinuria is clinically beneficial".

Let's hope DMX-200 can provide meaningful benefit for a number of CKD patients in Australia and around the world.

Cheers
A.

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OK I'm in for a punt .

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OK I'm in for a punt .

Think you may find its much much better than a punt - Ive invested 20k in it to see what happens as i believe some of the following questions will all be answered soon - the following are the questions ive recently put to management and remember that previous tests have already proven its effectiveness but they have to go through the stages and test it more broadly :) ;) - it could run to 2c on no news - last run was large volume and ran to 1.7c / 1.8c - Anyway DYOR people

1) As I understand, there are only two companies with an orphan drug designation for FSGS- Dimerix and Retrophin ?

2) Should DMX-200 "meets the criteria to reduce proteinuria through current trials, does this result in potential partners coming on board or is this further out ?

3) What do you consider to be clinically beneficial in terms of proteinuria reduction 25%?

4) If the current stage 11 clinical trials in patients, if proven to lower proteinuria, would this validate the Receptor-HIT platform?
5) I understand the FSGS market in the US to be CIRCA >$1Bn – is this your belief?
6) What does Orphan status mean for Dimerix and its investors?? Does it mean exclusivity of proven??
7) How soon could we get this DMX-200 to market realistically?
8) Are we more likely to have the broader CKD market or a large pharmaceutical take a stake if proven which could mean significant upfront and decent milestones and royalties?
9) Is it possible once clinical trials successful to get a Nasdaq listing ?

10) If DMX-200, if proteinuria reduction can be safely shown to occur with the combination in excess of IRB alone, then could we apply to the broader CKD market?

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Buyers stepping up and now at 1.6c
Technically speaking - if we break 1.6c we should retest previous high quite easily IMO

GLTA :)

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Heres another clue people - "Dimerix aims to provide an interim data analysis based on 10-15 patients in the trial before the end of
the third quarter of 2016. "!!!!!!!

Dimerix reaches 10 patient milestone and on Track to Report Interim Phase II Trial Data of DMX-200 in Patients with Chronic Kidney Disease in Q3 2016


this announcement below from June :)
6 June 2016
:
Dimerix Limited
(ASX: DXB)
,a clinical-stage biotechnology company committed to discovering and developing new therapeutic treatments
identified using its proprietary screening assay, today announced it is on track to report interim data from its Phase II trial of DMX-200 in patients with chronic kidney disease (CKD) after passing the milestone of 10 patients dosed.

Dimerix Executive Chairman Dr James Williams said,
“The milestone of dosing 10 patients is an important one ,as it should enable interim information to be elucidated under the trial. It confirms we
are meeting the recruitment targets and timelines previously communicated to the market.”
In total 11patients have been dosed and the first two patients recruited have completed the dose escalation stage.
Identified using Dimerix’s proprietary screening assay, termed Receptor-Heteromer Investigation Technology (Receptor-HIT)
,DMX-200 combines two existing drugs, a chemokine receptor CCR2 blocker (propagermanium) used for its anti
-inflammatory properties, and an angiotensin II type I receptor blocker (irbesartan) which is registered in the USA for hypertension and treatment of diabetic nephropathy in certain patients.

Part A of the current Phase II open label trial aims to recruit up to 30 patients at four sites across Melbourne with the aim of demonstrating safety and reduction of proteinuria in patients with CKD.

Proteinuria is common in CKD patients and is a strong independent risk factor for disease progression. Reducing proteinuria reduces the risk of CKD progression and its consequences of progressive loss of renal functionleading to renal failure, and the development and progression of cardiovascular disease.

Patients in the study are already being prescribed irbesartan and, as part of the trial protocol,commence on a dose of 30mg of propagermanium per day. The Investigators review the patients at four week intervals, and escalate the patients’dose to 60, 90, 150 and 240mg per day over each
fourweek period.

The supply of propagermanium to patients following their participation in the trial can be approved under the Australian TGA’s Special Access Scheme.
The first patient to complete the DMX-200 Phase II trial is continuing to access propagermanium under this Special Access Scheme
.
Dimerix aims to provide an interim data analysis based on 10-15 patients in the trial before the end of
the third quarter of 2016. -
END
-

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Heres another great article leading into phase ii trial results by end of this week - check out the Authors comments in the third sentence which talks about us DXB :)

http://seekingalpha.com/article/4005552-retrophin-strong-buy-positive-sparsentan-results

Summary

Sparsentan's treatment effect in FSGS patients significantly outperformed management's hopes for a 50% improvement in the reduction of proteinuria levels over patients in the control arm.

Martin Shkreli should be lauded for bringing hope to FSGS patients and promising data positively reflects on the prospects of other pipeline candidates including RE-024 in PKAN patients.

Investors should keep an eye on competition from ASX-listed Dimerix Limited, whose FSGS candidate, DMX-200, will report interim results in Q3 2016.

Even after the ~30% increase, Retrophin shares continue to appear undervalued and investors might do well to buy on weakness.

In my previous article, I outlined how Retrophin (NASDAQ:RTRX) was trading at what I considered a cheap valuation, due in part to its being synonymous with founder and former CEO Martin Shkreli. Shkreli had previously been voted the most hated man in America, strung up and placed before Congress as the poster boy of pharmaceutical greed.

I argued that the company's core business of approved drugs with full year sales guidance of $130 to $140 million, coupled with its $315 million cash position and intriguing pipeline of ultra-rare disease candidates was worth considerably more than its $600 million market cap.

While CEO of Retrophin, Shkreli had the foresight to in-license its first clinical candidate sparsentan from Ligand Pharmaceuticals (NASDAQ:LGND), to which it owes milestone payments and 9% royalties on future sales. Sparsentan is being developed as a treatment for focal segmental glomerulosclerosis (FSGS), a rare condition that is one of the leading causes of end stage renal disease.

Symptoms of the disease include proteinuria (leaking of protein into the urine), painful swelling (edema), and high blood pressure. There is no currently approved treatment for the condition, and doctors often resort to prolonged steroid therapy to induce remission in patients. However, only about 30% of patients respond to treatment and treatment often results in high levels of toxicity.

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LOOKS like DXB about to break out - pressure building and once we clear 1.6c off it goes
announcement must be getting close for stage ii trials - looking like it could be positive considering they using existing drugs for CKD (Chronic kidney disease ) and improving them by adding superior to inprove the reduction in proteinuria by 50% - even at 25% improvement this will run hard considering it has price targget at 300% todays price - seems like the way to make money these days is improve on existing drugs which is what DXB are doing - makes it safer to get a positive result heading into stage 3 trials and FDA - could become a good earner for us taking risk at such low price


Dimerix aims to provide an interim data analysis based on up to 30 patients
in the trial before the end of the third quarter of 2016. NOW !!

There are only two companies with an orphan drug designation for FSGS- Dimerix (A$25M Mcap) and Retrophin (>A$1Bn Mcap). Should DMX-200 "pass with flying colours" and therein validate the Receptor-HIT platform (although any significant reduction on proteinuria beyond irbersartan alone I feel validates the technology, flying colours or otherwise), then we are talking a serious valuation. The FSGS market is >$1Bn in the US alone. Orphan status (with 7 years exclusivity) means .... well, it means the company will probably get taken out after pivotal data. The value would have to be between US$0.5-1.0Bn I imagine with a significant upfront and decent milestones and royalties to follow; dependent on when that would occur. And should the technology platform therefore also pass with flying colours and produce more targets.. well- you've got a medium-sized biotech now. Again, very likely to be acquired by Pharma well in advance of this. To extract full value at that stage, we would have to be listed on the Nasdaq I believe. So I'd think somewhere between $0.50 to $1.00 conservatively should this occur.. Even with DMX-200, if proteinuria reduction can be safely shown to occur with the combination in excess of IRB alone, then we have a useful drug that is applicable to the broader CKD market. Although clinical trials to show this would have to be quite large and expensive, a pharma partner I think would find it very attractive to in-license. S0- orphan drug designation for FSGS or not, if DMX-200 shows decent proteinuria reduction (I'm looking for 20-25% reduction in this study) then I believe we have some very valuable. As a nephrologist friend of mine recently commented to me in general.. "any reduction in proteinuria is clinically beneficial".

aPOLOGIES in advance if this sounds like a ramp but im excited and know alot about this company and we have some of the best award winning management in their field. For more information go back to the beginning of this thread :)

GLTA

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Guys - this has just been posted on another site HC - looks good from the answers that have been provided

Hello shareholders - for the purpose of gaining a better understanding of current activities and to get the information and facts straight from the company, so i can make a better investment decision, a few days ago I sent some questions to Dimerix Management
Ive kindly received a response from Kathy Harrison which she has advised I can share with you all - here are the Q & A's Below

Dear .......

Thank you for your enquiry about Dimerix which was forwarded through to me. The answers to your questions are in blue below.
1) As I understand, there are only two companies with an orphan drug designation for FSGS- Dimerix and Retrophin ?
A: The orphan designation is not essential to commence clinical trials in an orphan disease, however Dimerix and Retrophin are the only companies we are aware of with Phase 2 programs which target this indication
2) Should DMX-200 "meets the criteria to reduce proteinuria through current trials, does this result in potential partners coming on board or is this further out ?
A: Partnering opportunities can occur at any time, although there are points which represent significant "de risking" stages. Dimerix will shortly release some interim data on the first part of the Phase 2 clinical trial, which mainly focusses on demonstrating safety and may show some indications of efficacy, and is intended to assist in determining the dose. It is expected this part will be complete in mid 2017, with the second part to be completed about 12 months later, with patients on one or two stable doses throughout the treatment to provide a better indication of efficacy. This is potentially a typical point where partnership discussions may progress.
3) What do you consider to be clinically beneficial in terms of proteinuria reduction 25%?
A: Although many nephrology clinical trials report outcomes based on an average reduction in proteinuria, there is no gold standard or FDA mandated endpoint based on this measure. Proteinuria is a surrogate endpoint for renal function and time to end stage renal disease. The situation is more complicated also because the effect of the reduction in proteinuria depends on how severe the condition is at the outset. We think it is important to look at the "number of responders" ie how many patients have a significant reduction 40-50% or greater, and therefore have a good chance of a long term benefit.
4) If the current stage 11 clinical trials in patients, if proven to lower proteinuria, would this validate the Receptor-HIT platform?
A: Data from small numbers of patients does not in itself scientifically "validate" the Receptor-HIT platform, however as the trial progresses and further data is obtained it supports the validation of the platform.
5) I understand the FSGS market in the US to be CIRCA >$1Bn – is this your belief?
A: The FSGS market is difficult to quantify specifically, however it is known that if FSGS patients progress to renal failure, the treatment options cost hundreds of thousands of US dollars per year, and that a current steroid based treatment (which has a number of downsides and is not always effective), costs around US$100,000 per patient per year.
6) What does Orphan status mean for Dimerix and its investors?? Does it mean exclusivity of proven??
A: Orphan designation means that the Orphan Drug Office at the FDA considers the disease targeted to be an "Orphan Indication" and that the treatment has the potential to be beneficial. The exclusivity is awarded once the therapy achieves registration (ie completes sufficient trials to satisfy the FDA that the drug can be sold).
7) How soon could we get this DMX-200 to market realistically?
A: As mentioned above we expect our Phase 2 trials to be completed in about 2 years. Based on the FDA feedback we have so far, we would then expect to go into a single pivotal Phase 3 study, which should be able to be completed in 1-2 years, depending on speed of recruitment.
8) Are we more likely to have the broader CKD market or a large pharmaceutical take a stake if proven which could mean significant upfront and decent milestones and royalties?
A: Positive Trial data could potentially enable a partnership to apply DMX-200 to the broader CKD indications
9) Is it possible once clinical trials successful to get a Nasdaq listing ?
A: Nasdaq listing has benefits and challenges and is not currently under consideration for Dimerix

[SCHUMACHER]

EXCELLENT RESULTS OUT NOW !!

http://www.aspectfinancial.com.au/docserver/01785793.pdf?fileid=01785793&datedir=20161004&edt=MjAxNi0xMC0wNCswOTo1Njo1OSsxMjArNjEyMDg3ODIrZX RyYWRleG1sK3JlZGlyZWN0Ky9pbWFnZXNpZ25hbC9lcnJvcnBh Z2VzL0V0cmFkZVBERlRpbWVvdXQuaHRtbCsvaW1hZ2VzaWduYW wvZXJyb3JwYWdlcy9wZGZkZWxheWVkLmpzcA==&popup=true

For Immediate Release
ASX/Media Release
Interim analysis supports continued development of DMX
-
200 for the treatment
of Chronic Kidney Disease
KEY POINTS:
Data from 21 participants shows the therapy is well tolerated with an encouraging safety profile
Twenty seven percent (27%, 3/11) patients who have reached or passed the mid-point of the study have shown an ~ 50% reduction or greater in proteinuria over and above standard of care
 Final data from Part A of the Phase 2 study is expected in 2H 2017 MELBOURNE, Australia, 4th
October 2016
:

[silu]

I don't really understand Biotechs so how can one explain the huge drop in SP after this apparently positive announcement?