Neuphoria Therapeutics has discontinued the development of its lead candidate, BNC201, in social anxiety disorder after the drug failed to demonstrate efficacy in the condition.
During the Phase III AFFIRM-1 trial (NCT06510504), an acute 225mg dose of the alpha-7 nicotinic acetylcholine receptor (α7 nAChR) inhibitor did not meet its primary endpoint, offering no statistically significant improvement to clinical measures of social anxiety.
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The primary endpoint used in the trial was the average of the performance phase of the public speaking challenge in Subjective Units of Distress Scale (SUDS), which is commonly used as a measure of social anxiety in clinical trials.
In another blow for BNC210, the drug also failed to meet its secondary endpoints, triggering no significant change in clinical global impressions severity (CGI-S) or patient global impressions improvement (PGI-I) scores.
GlobalData neurology analyst Jos Opdenakker mentioned that BNC210’s failure in the acute social anxiety disorder setting “may be related to trial design and endpoint sensitivity”.
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By GlobalDataWilliam Blair research analyst Myles Minter echoed this sentiment, noting that a 300mg dose of orally administered BNC210 takes two hours to reach peak concentrations in the blood, while the public speaking challenge was conducted just one hour after taking either the drug or placebo.
While this outcome will be disappointing for patients with SAD, there is still hope in Vistagen Therapeutics’ inhaled fasedienol, which is the only other drug currently in pivotal trials for this indication. The company is currently looking into the safety and efficacy of the nasal spray in the PALISADE-3 study (NCT06358651) and anticipates a topline readout this quarter.
In a research note, Minter noted that William Blair’s bet on inhaled fasedienol is “high risk in nature,” but “risk/reward heading into the data is skewed positively”.
If approved, inhaled fasedienol would provide patients with a new option, which will be welcomed as the most commonly prescribed drugs for social anxiety disorder are off-label medications such as SSRIs, beta-blockers and benzodiazepines.
However, Opdenakker caveats that, if the PALISADE-3 trial also fails to show positive results, it may reflect “broader challenges in demonstrating efficacy for novel non-benzodiazepine, non-antidepressant acute treatments in social anxiety disorder populations”.
Neuphoria pivots BNC210’s focus
Despite BNC210’s lack of efficacy in social anxiety disorder, the drug’s safety and tolerability profile remained favourable and consistent with previous trials. This will be a silver lining in the for Neuphoria, which is currently assessing its next steps for BNC210 with the “goal of maximising value for shareholders”.
Preliminary plans laid out by Neuphoria will see the company evaluate its next moves for BNC210 in post-traumatic stress disorder (PTSD) – another key area of development for the medication.
Opdenakker noted that this could be a better strategy for Neuphoria, stating: “The biotech has posted previous positive data with chronic daily dosing in PTSD, suggesting that the therapeutic approach or dosing regimen may need to be reconsidered.”
Once Neuphoria has re-evaluated these elements, Opdenakker believes that the biotech could “pivot its approach to explore different anxiety subtypes and dosing schedules”, which could prevent the full dismissal of BNC210.
Despite this ray of hope for BNC210, investors do not seem convinced in the drug’s future prospects, as the company’s share value has plummeted 67% – going from $15.21 at market open on 20 October to $4.90 at market open on 21 October following the news.
