Bionomics Ltd (ASX:BNO, OTCQB:BNOEF) has completed a successful End-of-Phase 2 (EoP2) meeting with the US Food and Drug Administration (FDA), paving the way for its lead asset BNC210 to enter Phase 3 trials for the acute treatment of Social Anxiety Disorder (SAD).
The meeting concerned a dataset from recently concluded Phase 2 PREVAIL studies.
“We are grateful for FDA’s support and guidance and very pleased to reach an agreement on key elements of Phase 3 design and other nonclinical components required for registration,” Bionomics president and CEO Spyros Papapetropoulos said.
“The FDA meeting outcomes provide external and independent validation of our position on the strength and Phase 3-enabling nature of the PREVAIL dataset.
“BNC210’s unique clinical profile seen in multiple anxiety disorders including SAD, Generalized Anxiety Disorder and in a panic model, was recently significantly enhanced by the positive results in Post-Traumatic Stress Disorder.
“BNC210, which has Fast-Track designation from the FDA for the acute treatment of SAD, has the potential to address a significant unmet need for the 17 million Americans suffering from SAD who currently don’t have fast-acting and safe treatment options.”
Official meeting minutes
FDA official meeting minutes reveal the specific areas Bionomics has reached an agreement with the regulator for, including:
- the plan to conduct two randomized, placebo-controlled studies with single administration of BNC210 during a public speaking task;
- the use of the Subjective Units of Distress Scale (SUDS) measured during a public speaking challenge as the primary efficacy endpoint;
- the doses of BNC210 to be studied in Phase 3;
- the sample size assumptions for the Phase 3 controlled studies based on PREVAIL findings;
- the design elements of the open label safety study required to support the new drug application (NDA);
- the size of the safety database to support the NDA; and
- the nonclinical toxicology studies needed to support the NDA.
Bionomics intends to begin Phase 3 of its clinical program in the first quarter of next year.