Bionomics provides update on BNC210 development

Bionomics provided a 2023 review and its outlook for 2024. Positive topline results from the Phase 2b ATTUNE study were announced in September 2023, meeting the primary endpoint on reduction in total symptom severity and highlighting the potential of BNC210 to improve multiple Post-Traumatic Stress Disorder symptom clusters with effects on thought intrusions, mood, trauma-related cognition, and sleep. An EoP2 meeting with the FDA in September 2023 confirmed the Phase 3 enabling nature of the PREVAIL dataset and clarified plans for the registrational program for BNC210 in Social Anxiety Disorder. The ongoing partnership with Merck on alpha7 PAMs for the treatment of cognitive disorders such as Alzheimer’s disease and cognitive impairment associated with schizophrenia has generated two clinical candidates that are currently in late Phase 1 clinical development after completing several Phase 1 safety, tolerability, pharmacokinetic and biomarkers studies. The partnership has a potential value of $500M in regulatory and clinical milestones with additional potential royalties from commercialization. Future anticipated milestones for BNC210 include: plans to discuss a potential dose-ranging late-stage study of BNC210 in PTSD with the FDA; an update on the next steps is expected by the end of Q2’24. The company is exploring the submission of a request for Breakthrough Therapy designation in PTSD in Q2’24. The company is looking to secure a strategic partnership for BNC210.