Neuphoria Therapeutics’ lead candidate has failed to improve social anxiety symptoms in a late-stage trial, prompting the biotech to discontinue the program and launch a strategic review of its business.
The program in question is Neuphoria’s BNC210, also known as soclenicant, an α7 nicotinic receptor negative alteration modulator. A single 225-mg dose of BNC210 was tested against placebo in a double-blind phase 3 trial for acute treatment of social anxiety disorder.
The program failed to hit the study’s primary endpoint, which measured change from baseline on an industry “distress scale” during a public speaking challenge, according to an Oct. 20 release shared after market close.
The trial, dubbed Affirm-1, also failed to demonstrate statistically significant changes on secondary endpoints, which included self-assessments and clinician-measured assessments.
The safety and tolerability of the drug remained favorable, according to Neuphoria. The company has touted the candidate as providing rapid stress relief without common side effects that can be associated with currently approved treatments, like sedation or cognitive impairment.
Neuphoria’s stock has plummeted 67% after the announcement, dropping from Monday’s close of $15.40 per share to $5 as of 10 a.m. ET today.
Now, the Massachusetts-based biotech is discontinuing further development of BNC210 in social anxiety disorder.
“We plan to immediately take action to conserve our cash position by holding further investment in our programs and evaluating all options for Neuphoria’s path forward through a strategic review, with the goal of maximizing value for shareholders,” Neuphoria CEO Spyros Papapetropoulos, M.D., Ph.D., said in the release.
The biotech plans to assess next steps for BNC210 in post-traumatic stress disorder (PTSD), citing “previous positive data with chronic daily dosing.” At the end of September, Neuphoria said it was ramping up activities for a phase 2b/3 trial in PTSD that was expected to launch in the first half of 2026.
Neuphoria said it would provide an update from the strategic review by the end of this year.
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As of June 30, the biotech had $14.2 million in cash and cash equivalents, money expected to fuel the company through the second fiscal quarter of 2027.
Neuphoria also has an active partnership with Big Pharma Merck & Co. The pair is advancing two positive allosteric modulator candidates, one of which is currently being tested out in a Merck-led phase 2 study for Alzheimer’s disease. Merck is fronting the costs of the program, with Neuphoria in line to receive up to $450 million potential biobucks.
The biotech also has a deal with Carina Biotech to develop a legacy oncology program.
