Neuphoria Therapeutics Inc.’s phase III study of social anxiety disorder has missed its primary and secondary endpoints, prompting the company to stop the program’s development and hold a full strategic review of its operations and portfolio. It’s the second stumble for lead candidate BNC-210, a negative allosteric modulator of alpha7 nicotinic acetylcholine receptor, in the indication.
Bionomics is progressing BNC-210 to phase III trials in post-traumatic stress disorder (PTSD) following positive feedback from the U.S. FDA. Final data from the phase II Attune study showed that BNC-210 improved PTSD symptom severity at week 12 with efficacy observed as early as week four.
Positive top-line data from the phase IIb study of BNC-210 to treat post-traumatic stress disorder (PTSD) supercharged Bionomics Ltd.’s stock. Shares (NASDAQ:BNOX) closed trading a dramatic 243.8% higher at $3.37 each on Sept. 28. The oral, selective negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor stumbled last December in a phase II trial for treating social anxiety disorder but now has regained momentum.
Positive top-line data from the phase IIb study of BNC-210 to treat post-traumatic stress disorder (PTSD) supercharged Bionomics Ltd.’s stock. Shares (NASDAQ:BNOX) closed trading a dramatic 243.8% higher at $3.37 each on Sept. 28. The oral, selective negative allosteric modulator of the alpha7 nicotinic acetylcholine receptor stumbled last December in a phase II trial for treating social anxiety disorder but now has regained momentum.
Bionomics Ltd. is gearing up for an end-of-phase-II meeting with the U.S. FDA later this year to discuss the full results from the phase II study called Prevail in social anxiety disorder (SAD) with BNC-210, which missed its primary endpoint but yielded encouraging signs. Top-line data were disclosed last December. An oral alpha-7 nicotinic acetylcholine receptor negative allosteric modulator, BNC-210 fell short in change from baseline to the average of the Subjective Unites of Distress Scale (SUDS) during a five-minute public speaking challenge.
Bionomics Ltd.’s U.S. debut last December, when the firm raised about $23 million through the sale of American depositary shares, called new attention to the Australian firm and its prospects in social anxiety disorder (SAD) and post-traumatic stress disorder (PTSD).
PERTH, Australia – Adelaide, Australia-based Bionomics Inc. reported another trial failure with its lead compound, BNC-210, in elderly patients with agitation, but it is still clinging on to hopes that the compound will show a clinical benefit for post-traumatic stress disorder (PTSD).
