Bionomics' BNC210 Shows Positive Phase 2 Results in PTSD Patients, Phase 3 Planned
核心洞察
Bionomics' BNC210 demonstrated statistically significant improvement in PTSD (搜索) symptom severity compared to placebo at Week 12, with benefits observed as early as Week 4.
The Phase 2 ATTUNE study also revealed clinically meaningful improvements in depressive symptoms and sleep quality among patients treated with BNC210.
Bionomics is advancing BNC210 to a Phase 3 trial for PTSD (搜索), slated to begin in the second half of 2025, following positive FDA feedback.
Bionomics Limited has announced the publication of positive results from its Phase 2 ATTUNE study of BNC210 in patients with post-traumatic stress disorder (搜索) (PTSD (搜索)) in NEJM Evidence. The drug, a novel, first-in-class, allosteric ion channel modulator, showed significant improvements in PTSD symptoms and related conditions. The company plans to initiate a Phase 3 study of BNC210 in PTSD in the second half of 2025.
Phase 2 ATTUNE Study Results
The ATTUNE study demonstrated that BNC210 led to a statistically significant improvement in the Clinician-Administered PTSD (搜索) Scale for DSM-5 (CAPS-5) total score at Week 12 compared to placebo (p=0.048). Improvement was observed as early as Week 4. Furthermore, clinically meaningful and statistically significant improvements were also observed with BNC210 versus placebo in depressive symptoms, measured by the Montgomery–Åsberg Depression Rating Scale, and sleep quality, assessed by the Insomnia Severity Index.
Treatment-emergent adverse events (AEs) occurred in 70 (66.7%) patients in the BNC210 group and 56 (53.8%) in the placebo group. The most common AEs were headache, nausea, fatigue, and hepatic enzyme elevations.
Expert Commentary
Murray B Stein, M.D., M.P.H., Distinguished Professor of Psychiatry and Public Health at the University of California San Diego and a senior author of the paper, commented, "This publication highlights the encouraging and clinically meaningful improvements seen with BNC210 across several key PTSD (搜索) symptoms. Fewer than 50% of patients experience benefit with currently approved treatments and therefore there is a pressing need for new, well-tolerated, efficacious treatments. The ATTUNE data, along with the additional clinical data of BNC210 to date, positions it as a promising potential treatment and I look forward to further seeing it assessed it in a larger Phase 3 trial."
BNC210: A Potential Novel Treatment for CNS Disorders
BNC210 is an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor (搜索). Bionomics is also evaluating BNC210 in a Phase 3 AFIRM-1 study in social anxiety disorder (搜索) (SAD (搜索)), with anticipated readout in Q3 2025.
"We are excited to publish the results of the ATTUNE in NEJM Evidence, a prestigious journal for innovative original research. This peer-reviewed publication further validates these significant results and underscores the differentiated clinical profile of BNC210, a potential best- and first-in class treatment for PTSD (搜索) that is non-psychedelic, non-sedating and non-habit-forming," said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. "Since our successful End-of-Phase 2 meeting with the FDA earlier this year, we have been diligently preparing for the Phase 3 study of BNC210 in PTSD which we anticipate initiating in the second half of 2025, if not sooner."