Bionomics’ PTSD Candidate Clears Phase IIb Study, Stock Jumps 415%

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Topline data from the Phase IIb ATTUNE trial showed that Bionomics’ investigational ion channel modulator BNC210 met the study’s primary endpoint, significantly reducing symptoms in patients with post-traumatic stress disorder, the company announced Thursday.

After 12 weeks of treatment, patients who were given BNC210 saw strong improvements in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The effect was statistically significant, according to the company’s announcement.

Significant improvements in CAPS-5 scores were apparent as early as week four and were maintained through week eight.

The results from ATTUNE could “enable FDA discussions for the registrational path of BNC210 in PTSD,” according to Bionomics CEO Spyros Papapetropoulos.  These data also position the candidate “as a compelling late-stage experimental therapeutic for multiple prevalent neuropsychiatric diseases with high unmet need,” Papapetropoulos said in a statement.

Bionomics’ stock price skyrocketed more than 400% in Thursday trading after the company announced the Phase IIb trial results.

BNC210 is a negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor, according to Bionomics’ website. In both clinical and non-clinical studies, the molecule has demonstrated a “differentiated mechanism of action” and the potential to treat neuropsychiatric and mood disorders such as social anxiety disorder (SAD) and PTSD.

In ATTUNE, a double-blinded and placebo-controlled trial, the candidate was given twice daily at a 900-mg dose. Aside from the primary endpoint of change in CAPS-5 scores, the study also looked at key secondary endpoints, including physician- and patient-reported symptom burden.

At 12 weeks, BNC210 treatment significantly eased depressive symptoms, measured using the Montgomery-Åsberg Depression Rating Scale, and improved sleep according to the Insomnia Severity Index. There were also favorable trends in other scales, including the symptom severity domain of the clinician and patient global impression inventories, as well as the Sheehan Disability Scale.

As for safety, ATTUNE detected a higher rate of hepatic enzyme increase om BNC210-treated patients, though these abnormal findings did not lead to hepatic injury and most resolved without needing to stop treatment. The most common toxicities were headache, nausea and fatigue.

Thursday’s PTSD data come after a disappointing readout for BNC210 in December 2022, when top-line results from the Phase II PREVAIL study showed that the candidate failed to ease symptoms in patients with SAD. A few months later, in March 2023, a full analysis of PREVAIL confirmed that BNC210 fell short of the study’s primary efficacy endpoint.

Nevertheless, Bionomics chose to focus on the positive, highlighting “encouraging trends in the prespecified endpoints” which support advancing BCN210 to late-stage development, according to the company.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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