The company is dropping its social anxiety disorder program but will still test the molecule in post-traumatic stress disorder.
Neuphoria Therapeutics reported that its small molecule treatment for social anxiety disorder missed the primary endpoint in a late-stage trial. Based on the results from AFFIRM-1, the company is halting development of its social anxiety disorder program, though it will continue to evaluate BNC210 for use in post-traumatic stress disorder.
The asset failed to improve self-reported measures of distress during a public speaking challenge in the Phase III AFFIRM-1 trial, the company said late Monday. The trial also missed its secondary endpoints, two other self-reported scales of symptoms and a clinician-scored test of patients’ global functioning.
William Blair analysts questioned the trial’s design and the pharmacokinetics of the drug. “Phase I data show BNC210 at a 300mg dose takes 2 hours in a fasted state to achieve [maximum plasma concentration], yet the public speaking challenge is conducted 60 minutes after taking either active drug or placebo,” the group wrote in a note to investors Tuesday morning.
The analysts looked ahead to VistaGen, which they wrote is the only other company running pivotal-stage clinical trials for social anxiety disorder. The company is currently testing an inhaled pherine spray fasedienol, with data from the phase III PALISADE-3 expected to read out sometime this quarter. That drug “activates chemoreceptors in the nasal passage and impacts amygdala function,” the William Blair analysts wrote, noting that this mechanism of action along with a different delivery mechanism—BNC210 is taken orally—could differentiate the drug from Neuphoria’s.
Dropping its social anxiety disorder program will help the company save money as it considers its options. “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,” Spyros Papapetropoulos, the company’s president and CEO, said in a statement.
In December 2024, Neuphoria read out data from a phase IIb trial showing that BNC210 had positive effects on PTSD symptoms at 12 weeks, with indications of efficacy even within four weeks.
BNC210 is an antinicotinic agent that targets the α7-nicotinic acetylcholine receptor to produce anti-stress and antidepressant-like effects. It was first developed by Bionomics before Neuphoria acquired the company in 2024, in a scheme of arrangement that made Neuphoria the parent company of Bionomics.
