Bionomics (ASX:BNO) has weak precedence to predict efficacy success in its Phase II trial for post-traumatic stress disorder (PTSD), experts said, disputing some industry analysts commenting that BNC210’s successes in other trials could spell primary efficacy success in the indication. Experts said the links are loose, while one expert noted that animal models showed strong results but translation into human benefit remains unproven.
Safety, however, seems to be of lower concern, with its mechanism of action known to have low sedation or impact on cognition.
An analyst report stated that given the lack of new drug approvals in PTSD in 30 years, Phase II results could trigger a Breakthrough Designation by the FDA and a possible expedited regulatory review path. However, Benjamin Chavez, PharmD, associate professor, Department of Clinical Pharmacy, University of Colorado Denver disagreed, saying that Breakthrough Designation status is typically granted for drugs in diseases where there are little to no treatment options. PTSD has multiple therapeutic options, albeit with varied efficacy.
BNC210 is in a 192-patient Phase II trial (NCT02933606) RESTORE, with results expected in 3Q18. The primary endpoint is improvement in PTSD symptoms in the categories of intrusion, negative alterations in mood and cognition, avoidance and arousal and reactivity, as measured by the Clinician-Administered PTSD Scale (DSM V) (CAPS-5). Secondary endpoints measure PTSD symptoms using other scales.
Analyst project peak sales of USD 1.4bn in 2022, and Bionomics has a market cap of AUD 255.8m.