Along with its near-term FSGS opportunity, the company is still fully committed to developing its DMX-200 treatment for Diabetic Kidney Disease (DKD).
For investors in biotech company Dimerix (ASX:DXB), 2021 is shaping up as a big year as the company pursues advanced clinical trials for its DMX-200 kidney treatment.
Near-term, Dimerix is focussed on building out its Phase 3 trial for the use of DMX-200 in the treatment of FSGS (focal segmental glomerulosclerosis) – a rare kidney disease that affects around 210,000 people globally each year.
The company is equally focused on preparing the longer-term research plans for its DMX-200 treatment against Diabetic Kidney Disease (DKD), following positive and encouraging Phase 2 trial results in 2020.
With a busy year ahead, Stockhead caught up with Dimerix CEO Dr Nina Webster recently to discuss the company’s outlook.
In a wide-ranging interview, Webster detailed the scale of the market opportunity for DXB’s FSGS treatment, as well as the timelines involved in the clinical trial process.
“For us, FSGS is certainly the near-term opportunity with huge market potential,” Webster said.
“As we have always said, our DKD treatment follows traditional development process that requires additional larger trials with a longer pathway,” she explained.
“So from a strategic planning point of view, the FSGS treatment was always the one that was going to advance to Phase 3 in 2021, with DKD coming in behind that.”
Webster said the nature of FSGS means the per-unit economics of successful treatments are particularly lucrative. Globally, no other drug treatments to combat the disease have been approved.
DXB’s FSGS treatment has been granted Orphan drug status in both the US and Europe, which gives it an accelerated approval process and the opportunity to attract Orphan drug pricing.
“Interestingly, on a market scale, the valuation of the FSGS market with orphan pricing is very similar to DKD, which has far greater patient numbers, but where the unit treatment price is lower,” Webster said.
Market size
DXB’s orphan drug designation effectively means it’s been accepted by health regulators as a possible solution for an unmet health issue in a rare disease where no other treatments currently exist.
DMX-200 is the only treatment currently in development that deploys a chemokine receptor (CCR2) blocker to treat the disease.
Other drug treatments for FSGS are under development, but do not act on the same biological pathway, which means DMX-200 is a globally unique solution, Webster said.
“We’re not a competitor to others in development, which target the angiotensin and endothelin receptors. The way it would work is that our treatment would most likely be complementary to those treatments,” she said.
“Our treatment, DMX-200, works together with angiotensin II receptor blocker, for which we add further benefits, and that’s what we’ve demonstrated in all our studies to date.”
In that context, the size of the market opportunity is particularly exciting for the company.
For starters, DXB’s orphan drug status likely gives it exclusivity periods of seven and ten years for the US and Europe, respectively.
“If you look at the prevailing trend in pharmaceutical markets, and from my personal experience, it’s moved into this litigious area whereby when a product hits the market the patents are challenged. So that (exclusivity period) is a key advantage, even with our strong portfolio of granted patents” Webster said.
Then there’s the fact the FSGS treatment can attract orphan drug pricing. In the US, the average orphan drug retails at around $US7,000 per month, in Europe it is around $US3,500 per month.
Of the ~210,000 patients diagnosed with the disease globally each year, around 80,000 are in the US.
Breaking down the numbers, if everyone received treatment, the total addressable US market would amount to almost $US7bn.
“FSGS is diagnosed by biopsy,” Webster explained.
“In the US, you would typically need to have health insurance to get a biopsy, which in turn means you’ll get access to the drug through your insurance program,” she said.
“So the probability is that the majority of those patients diagnosed will get access to treatment, and that treatment would retail at orphan drug prices, the average of which is around $US7k per month.”
Timeline
With a single Phase 3 trial agreed with the US FDA, Dimerix is aiming to have its FSGS program initiated by the middle of this year.
Dimerix also has the opportunity to pursue accelerated approval using a surrogate endpoint, which is the amount of protein in the urine.
As a frame of reference, a person with functioning kidneys has no protein in the urine.
“Traditional studies usually focus on the length of time to end-stage renal failure which can take years. So measuring protein in urine is a very straightforward study from that perspective,” Webster said.
Accelerated approval would give Dimerix the opportunity to take its drug to market while completing the finer points of the trial program.
With targeted recruitment timelines for FSGS, DMX-200 could conceivably be on market as early as 2023. Assuming unlimited resources, the size and complexities of the DKD studies would not see that product approved until at least 2026, meaning it naturally follows the premium pricing afforded by the orphan designation and exclusivity expected for the FSGS opportunity.
So the timeline for FSGS has always been a 2021 story. But Webster reiterated that the company is still very much focused on the longer-term pathway for its DKD treatment.
Simultaneously, the company’s chemokine receptor (CCR2) blocker is also being deployed in two external studies to test its effectiveness in the treatment of COVID-19 respiratory problems, run by two different investigator groups, REMAP-CAP and CLARITY 2.0. Results from those studies are also expected later this year.
“We are focused on FSGS near-term, however DKD still represents a huge opportunity as well,” Webster said
“So we’re assessing and designing the next stage of that DKD study, with the understanding it was always going to be a longer development pathway.”
“It’s a much larger study program with more participants. That (longer time frame) was always going to be the case, because it’s a traditional pathway where we’re not eligible for accelerated approval,” she said.
“So we’re designing and working on that next stage for DKD. And in the meantime we’re actively preparing for initiating a Phase 3 study in FSGS. That’s the near-term opportunity and a key inflection point for our shareholders as well.”
This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions
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