Three days after appointing its next CEO, Bionomics had to break the news to investors that its lead asset has flunked a phase 2 trial in acute social anxiety disorder (SAD).
The candidate, dubbed BNC210, failed to hit the primary endpoint of demonstrating a change from baseline as measured during a public speaking challenge when compared to placebo. The trial saw 151 participants receive either a 225-mg or 675-mg dose of BNC210 or placebo then allowed a rest period of just under an hour before delivering a five-minute speech. Afterward, these individuals rated the intensity of their anxiety, fear or distress.
Searching for positives, the central nervous system-focused company said the findings “do indicate a consistent trend toward improvements across primary and secondary endpoints and a favorable safety and tolerability profile consistent with previously reported results.”
BNC210 is a negative allosteric modulator of the α7 nicotinic acetylcholine receptor, and Bionomics Executive Chairman Errol De Souza, Ph.D., said the therapy’s mechanism of action remains “promising.” The Australian biotech will continue to analyze data from the PREVAIL trial as well as assess next steps for the development of BNC210 in SAD.
An estimated 31 million Americans will suffer from SAD at some point in their lives, the company noted.
“We look forward to welcoming our new president and CEO, Spyridon ‘Spyros’ Papapetropoulos, MD, Ph.D., who has extensive experience in CNS clinical development to work with the Bionomics team to conduct further analysis on the PREVAIL study data and consult with key opinion leaders and regulators in order to define next steps for the program,” De Souza said in a Dec. 18 release.
BNC210 is also undergoing a phase 2 trial for post-traumatic stress disorder with a top-line readout due in the middle of next year. The biotech’s only other candidates in the clinic are two assets from a collaboration with Merck & Co. that are in a phase 1 study for cognitive deficit in patients with Alzheimer’s disease.
The company had $31.4 million in cash as of the end of September, and De Souza said this “strong cash position … will enable delivery of these milestones along with continuing operations to at least mid-2024.”