- The shares of clinical-stage biotech, Aptinyx (NASDAQ:APTX) have lost ~53% in the pre-market Thursday after the company announced that its Phase 2b clinical study for NYX-2925 did not reach the primary endpoint in patients with painful diabetic peripheral neuropathy (DPN).
- The 229-patient randomized, double-blind study did not demonstrate a statistically significant separation from placebo in terms of its primary endpoint, which was the change in pain from baseline measured over 12 weeks using a rating scale, the company said.
- “We are clearly disappointed that the study did not meet its primary endpoint,” Chief Executive Andy Kidd remarked, adding, “unfortunately, the data from this study do not currently point to a path forward in development for painful DPN.”
- However, the experimental therapy was well tolerated in the trial with no “concerning safety issues.” according to Aptinyx (APTX).
- NYX-2925 is currently undergoing a Phase 2b study for fibromyalgia, with data expected in mid-3Q 2022, the company said.
In October, Aptinyx (APTX) announced the completion of enrollment in the DPN study with plans to report results in mid-2Q 2022.