Bionomics announces end-of-Phase 2 meeting with FDA, solidifies plan for BNC210

Bionomics announced the successful and favorable outcomes of an End-of-Phase 2 meeting meeting with the U.S. Food and Drug Administration, FDA, supporting the advancement of its lead asset BNC210 for the acute treatment of Social Anxiety Disorder, SAD, into Phase 3 registrational studies based on the recently completed Phase 2 PREVAIL dataset. On October 11, Bionomics received the official meeting minutes from the EoP2 meeting with the FDA held on September 13, 2023 reflecting that Bionomics has reached an agreement with the FDA on: 1) the plan to conduct two randomized, placebo-controlled studies with single administration of BNC210 during a public speaking task; 2) the use of the Subjective Units of Distress Scale measured during a public speaking challenge as the primary efficacy endpoint; 3) the doses of BNC210 to be studied in Phase 3; 4) the sample size assumptions for the Phase 3 controlled studies based on PREVAIL findings; 5) the design elements of the open label safety study required to support the new drug application; 6) the size of the safety database to support the NDA; and 7) the nonclinical toxicology studies needed to support the NDA.