Dimerix has confirmed the global interest in its DMX-200 treatment for the rare kidney disease FSGS by securing its third licensing agreement. The latest deal is with FUSO Pharmaceutical Industries for the Japanese market. The deal includes an upfront payment of $3.1 million, a short-term milestone payment of $4.1 million expected this quarter (upon the opening of the first Japanese site), an additional $30 million in development milestones, and $70 million in sales milestones. Dimerix will also receive royalties from net product sales, ranging from 15% to 20%.
Importantly, FUSO will cover all clinical trial costs in Japan. The company expects that only 20 patients will be needed from Japan to complement the 286-patient global Phase III study currently underway by Dimerix.
Other completed deals include agreements with Advanz Pharma for Europe, Canada, and Australasia, and with Taiba for the Middle East. The remaining priority regions are the US and China. Dimerix has strategically opted to secure regional licensing deals rather than a single global agreement. This approach reduces the risk of relying on one third party and helps ensure broader international reach.
Phase III Study Update and Interim Data
Interim data from the first 144 patients in the Phase III study, who have completed 35 weeks of treatment, is expected in August. At that time, the Independent Data Monitoring Committee (IDMC) will review the blinded data and make recommendations to Dimerix. Similar to the first blinded interim analysis conducted in March of the previous year, this data will help determine whether the trial is progressing toward achieving its endpoint of a statistically significant result. The first interim analysis suggested that a "statistically significant and clinically meaningful result in reducing proteinuria" could be possible, indicating that the trial is on track and does not need to be expanded.
One factor that may influence the process is Dimerix's upcoming meeting with the FDA. Recommendations from the Project PARASOL working group, which included the FDA, suggested that proteinuria could be an acceptable primary endpoint for approval, with lower thresholds being considered as a successful outcome. Currently, FDA approval for kidney diseases typically uses eGFR (estimated glomerular filtration rate) as the primary measure, but eGFR is highly variable in patients with FSGS and can take two years to assess.
If proteinuria is accepted as the primary endpoint by the FDA, this could impact when Dimerix chooses to unblind its data. Regulatory endpoints in other regions will also need to be taken into account.
Financial Overview
Dimerix is currently capitalized at $282 million and had $19 million in cash at the end of September. The company expects to receive an additional $21 million by the end of the year from an R&D rebate (already received), payments from FUSO, and the exercise of share options.
Bioshares Recommendation: Speculative Buy Class A
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