Bionomics' midphase PTSD trial hits primary endpoint, briefly tripling its battered share price

 Bionomics’ bid to bounce back from its stock-crushing anxiety trial failure has finally gained some momentum, with investors sending the share price up almost 200% on the strength of phase 2 data in post-traumatic stress disorder (PTSD).

The PTSD trial, which ran across 34 U.S. and U.K. sites, randomized 212 people to take BNC210 or placebo twice a day. After 12 weeks, scores on a PTSD symptom scale had improved by more in the treatment arm than in the placebo group, causing the study to hit its primary endpoint with a p-value of 0.048. The PTSD scores were also better in the treatment arm than the control group at weeks 4 and 8.

Bionomics shared the top-line primary endpoint data alongside a look at the results of two secondary objectives. Participants taking BNC210 scored significantly better on measures of depressive symptoms and sleep at Week 12, with the p-value in both cases coming in around 0.04. 

The trial found “signals and trends across visits in the other secondary endpoints,” Bionomics said, but the statement only included a sprinkling of efficacy data. Bionomics shared a glimpse at safety, reporting liver enzyme increases in 13.3% of patients on BNC210. The rate was higher than in the placebo arm, 0.19%, but no patients suffered liver injury and most cases resolved without drug discontinuation.  

Overall, Bionomics said the safety and tolerability profile was favorable and consistent with earlier trials of BNC210, the candidate tested in the failed anxiety trial. In the biotech’s view, the mix of safety and efficacy data is compelling enough to talk to the FDA about the path to approval for the drug candidate in PTSD. 

Bionomics continues to see a future for BNC210 in social anxiety disorder, too, despite its midphase trial missing the primary endpoint late last year. The biotech dug into its data after learning about the failure, pointing to a post hoc analysis as evidence that the drug candidate reduces distress. The company has since met with the FDA to discuss registrational studies and is awaiting receipt of the formal meeting minutes.

The anxiety indication is a first-in-class opportunity for Bionomics, with no drugs currently approved in the U.S. for acute treatment, but the biotech faces competition in PTSD. The generic antidepressants sertraline and paroxetine are approved in the indication, and a clutch of companies are working on new drugs, including Lundbeck and Otsuka, which reported mixed phase 3 data this month. 

Shares in Bionomics briefly increased almost 200% in premarket trading. Even so, the stock was still trading under $3, well below the $4 it started the year on.

https://www.fiercebiotech.com/biotech/bionomics-midphase-ptsd-clinical-trial-hits-primary-endpoint-doubling-its-battered-share