With the FDA having accepted the biomarker of proteinuria as a primary endpoint, it was going to be difficult for Dimerix (DXB: $0.215) to find a way to seek accelerated approval as well based on interim data. Dimerix is conducting a global Phase III study with DMX200 for the orphan kidney disease FSGS.
Initially the plan was to potentially seek accelerated approval using proteinuria from the first 144 patients, to be followed up with full/traditional approval after treatment of all patients for two years using the marker of eGFR.
The issue is however that proteinuria is believed to be a more accurate measure of the decline of kidney health than eGFR. If Dimerix was to use proteinuria for accelerated approval, submitted the dossier now to the regulator and misses the final approval endpoint using eGFR, then the product could be removed from the market. And to use proteinuria for both approvals would reduce the statistical powering of the study.
The more risk averse approach is to delay the submission by two years, filing in 1H 2028 with proteinuria as the main endpoint.
An interim blinded analysis on the current data that has been generated indicates that the company has a greater than 90% chance of success. The last patient (333) received their first treatment in March this year, which means final data from the study will be received in March 2028.
Funding
At the end of March, Dimerix had $26.6 million in cash, with $11.5 million spent in the quarter. Its funding position out to 2029 is the key risk for the company and investors, with the probability of clinical success in the Phase III study underway now being high (greater than 90% according to the independent data monitoring board). However there are a number of avenues for the company to increase or preserve its cash position. These options are:
- Upfront payments from licensing DMX200 in outstanding territories - China, South Korea and Latin America
- Milestone payments from existing partners, which could include when the company receives results from the Phase III study, or files DMX200 for approval in a relevant territory
- Non-dilutive funding for up to $70 million, with deal terms already received (to be paid back from milestones or future royalties)
- A reduction in cash burn now that the final patient has been enrolled, and around one quarter having completed treatment.
So far, 93% of patients who have completed the study have moved to the open label extension phase (74/80). The safety profile of DMX200 has shown to be excellent, the first interim analysis was passed, as well as the second blinded analysis indicating a high chance of reaching statistical significance (greater than 90%) on the marker of proteinuria. CEO Nina Webster said that most (Phase III) trials are powered for greater than an 80% chance of success.
For full approval, Dimerix will need to achieve statistical significance on the measure of proteinuria, as well as at least a positive trend on the eGFR measure. Its study is being conducted across 21 countries at 219 sites.
Dimerix is a quality biotech. Its top 10 shareholders are institutional or high net worth investors. It is capitalized now at just $129 million.
Bioshares recommendation: Speculative Buy Class A
Competitor News
One of Dimerix's competitors, Travere Therapeutics, received approval for the treatment of FSGS last month for its drug Sparsentan (now called Filspari). This is the first drug approved for FSGS. The company's market capitalization increased by US$1.05 billion overnight.
Filsari was trialed in a 371 patient Phase III study. In 2024, the company went for accelerated approval using eGFR, but the data was not good enough. Two years later the company has secured approval with an improvement in proteinuria levels (18% over control) and a p-value of 0.03.
Filspari blocks the angiotensin II Type one receptor and could be used with DMX200 for an even greater benefit. Some of the patients in Dimerix's study were taking Filspari as well. Filspari is the most widely used drug for the treatment of IgA Nephropathy.
The Travere example highlights the patience and persistence in drug development, particularly in renal diseases where two year treatment timeframes are generally required.
Its outcome highlights the considerable value in Dimerix should it achieve a positive Phase III result, which is looking more likely, albeit not under an accelerated approval process.
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