Exciting news emerged from Bionomics as it unveiled the results of the Phase IIb ATTUNE trial, showcasing the promising potential of its investigational ion channel modulator, BNC210, in treating post-traumatic stress disorder (PTSD). The trial’s topline data demonstrated that BNC210 effectively met its primary endpoint by significantly alleviating symptoms in PTSD patients.
After 12 weeks of treatment, those receiving BNC210 witnessed substantial improvements in their PTSD symptoms, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The impact proved to be statistically significant, offering hope to those struggling with this condition.
Encouragingly, the positive effects of BNC210 became apparent as early as week four and remained consistent through week eight.
The results obtained from ATTUNE are significant as they may pave the way for discussions with the FDA regarding the potential registration of BNC210 for PTSD treatment, according to Bionomics CEO Spyros Papapetropoulos.
Additionally, these findings position BNC210 as a compelling late-stage experimental therapeutic with the potential to address various prevalent neuropsychiatric diseases characterized by significant unmet needs, as stated by Papapetropoulos in a recent announcement.
Following the announcement of the Phase IIb trial results, Bionomics experienced an astonishing surge in its stock price, soaring more than 400% during Thursday’s trading.
BNC210 functions as a negative allosteric modulator of the alpha 7 nicotinic acetylcholine receptor, as detailed on Bionomics’ website. In both clinical and non-clinical studies, this molecule has displayed a differentiated mechanism of action with the potential to treat neuropsychiatric and mood disorders, including social anxiety disorder (SAD) and PTSD.
In the ATTUNE trial, a double-blinded, placebo-controlled study, patients received BNC210 at a 900-mg dose twice daily. In addition to the primary endpoint focusing on CAPS-5 score changes, the trial also evaluated key secondary endpoints, such as physician- and patient-reported symptom burden.
At the 12-week mark, BNC210 treatment not only significantly alleviated depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale, but also improved sleep, as indicated by the Insomnia Severity Index.
Furthermore, there were positive trends observed in various other scales, including the symptom severity domain of clinician and patient global impression inventories, along with the Sheehan Disability Scale.
Regarding safety, the ATTUNE trial identified a higher incidence of hepatic enzyme increases in BNC210-treated patients. However, these abnormalities did not lead to hepatic injury, and most cases resolved without necessitating treatment discontinuation. The most commonly reported side effects included headache, nausea, and fatigue.
Notably, this positive development comes on the heels of a disappointing outcome for BNC210 in December 2022. At that time, top-line results from the Phase II PREVAIL study indicated that the candidate did not significantly alleviate symptoms in SAD patients.
However, a few months later, a comprehensive analysis of PREVAIL revealed encouraging trends in prespecified endpoints, prompting Bionomics to emphasize its commitment to advancing BNC210 to late-stage development.