Bionomics is making a remarkable resurgence following a significant setback caused by the failure of an anxiety trial, with investors propelling the company’s share price up by nearly 200%. This resurgence is attributed to promising phase 2 data in the context of post-traumatic stress disorder (PTSD).
The PTSD trial, conducted across 34 sites in the United States and the United Kingdom, involved randomizing 212 participants to either receive BNC210 or a placebo twice daily. After 12 weeks, there was a notable improvement in PTSD symptom scale scores within the treatment group compared to the placebo group. This achievement marked the study’s successful attainment of its primary endpoint, supported by a p-value of 0.048. Furthermore, the treatment arm outperformed the control group in PTSD scores at weeks 4 and 8.
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Bionomics disclosed the primary endpoint data alongside findings from two secondary objectives. Participants receiving BNC210 exhibited significantly enhanced scores in measures of depressive symptoms and sleep by Week 12, with p-values hovering around 0.04 in both cases.
While the trial showcased “signals and trends across visits” in other secondary endpoints, the provided statement offered limited efficacy data. Regarding safety, Bionomics reported liver enzyme elevations in 13.3% of patients receiving BNC210, slightly higher than the 0.19% observed in the placebo group. Notably, no patients experienced liver injury, and most instances resolved without discontinuing the drug. Bionomics asserted that the safety and tolerability profile aligns favourably with prior BNC210 trials. Bolstered by this data, the company aims to engage with the FDA to explore the path to drug approval for PTSD treatment.
Bionomics remains committed to BNC210’s potential in treating social anxiety disorder, despite a mid-phase trial missing its primary endpoint in late 2022. The company conducted an in-depth analysis of the data, highlighting a post hoc analysis as evidence of the drug’s distress-reducing capabilities. Subsequently, they engaged with the FDA to discuss registrational studies and are awaiting formal meeting minutes.
While the anxiety indication presents a pioneering opportunity for Bionomics, with no approved drugs for acute treatment in the U.S., competition is fierce in the PTSD arena. Generic antidepressants sertraline and paroxetine have approval, and several companies, including Lundbeck and Otsuka, are developing new drugs, with mixed phase 3 data recently reported.
The surge in Bionomics’ shares, briefly climbing almost 200% during premarket trading, signifies renewed confidence. Nevertheless, the stock still trades below $3, a considerable distance from the $4 mark it began the year with.
