Clene claims its PhII MS trial, half its intended size, cleared the primary goal. But can the biotech afford PhIII?
Clene Nanomedicine said its gold nanocrystal-based drug candidate, which failed an ALS trial last year, was better than placebo in a mid-stage study of patients with multiple sclerosis. But there are some big caveats to flag here.
The Phase II VISIONARY-MS study enrolled less than half (73 of 150) of the planned patient population, which the biotech has previously attributed to Covid-19. The trial was conducted in Australia, a point mentioned during an investor call when noting the study was mainly white (95% of patients). And it failed in the intent-to-treat group, only passing muster on the primary endpoint after excluding a group of patients.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.