HQ Team
September 29, 2023: Bionomics Limited, a clinical-stage biotechnology company announced positive outcomes for its experimental drug to treat post-traumatic stress disorder (PTSD).
During the mid-stage trials of its drug called BNC210 involving 212 patients in the US and the UK, the investigations had met its primary endpoint of total symptom severity score.
“Treatment with BNC210 also showed statistically significant improvement both in clinician-administered and patient self-reporting in two of the secondary endpoints of the trial,” according to a company statement.
“BNC210 led to significant improvements at week 12 in depressive symptoms and sleep.” It also met the clinician and symptom severity parameters “considerably higher than currently approved therapies.”
FDA meetings
“We believe these results will enable FDA discussions for the registrational path of BNC210 in PTSD, which is an indication with high unmet need,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics.
These results, together with the results from the recently completed end-trial meeting with the FDA on social anxiety disorder, “positions BNC210 as a compelling late-stage experimental therapeutic for multiple prevalent neuropsychiatric diseases with high unmet need.”
Treatment with 900 mg twice daily BNC210 had a favourable safety and tolerability profile, according to Bionomics.
The most commonly reported adverse events, including headache, nausea, and fatigue, were consistent with previous studies with BNC210.
Unmet medical need
“There is a great unmet medical need for safe and effective treatments for the large population of patients suffering from PTSD worldwide,” said Murray B. Stein, MD, M.P.H., Distinguished Professor of Psychiatry and Public Health at the University of California San Diego.
There have been no new approved therapies for PTSD in the last 20 years, Mr Stein, who is a consultant to Bionomics, said.
Post-Traumatic Stress Disorder is a psychiatric condition that may occur in people who have experienced or witnessed a traumatic event, series of events, or set of circumstances.
People with PTSD have intense, disturbing thoughts and feelings related to their experience that persist long after the traumatic event has ended.
Flashbacks
They may relive the event through flashbacks or nightmares, may feel sadness, fear, or anger and may experience a sense of detachment or estrangement from others.
As a result of these feelings, people with PTSD may avoid situations or people that remind them of the traumatic event, and they may have strong negative reactions to commonplace stimuli such as loud noises or an accidental touch.
About eight of every 100 women and four of every 100 men will have PTSD at some point in their life, according to the National Centre for PTSD.
