Bionomics Meets The FDA: Lead Drug Candidate For Social Anxiety Heads To Phase 3

Biopharma company Bionomics Ltd. BNOX announced that, following an end-of-Phase 2 meeting with the Food and Drug Administration (FDA), the agency supports the entrance of lead drug asset BNC210 -a negative allosteric modulator- targeting acute treatment of Social Anxiety Disorder (SAD) into Phase 3 “registrational” studies. 

The clinical-stage biotech firm backed by billionaire Steve Cohen recently completed Phase 2 studies on the compound with positive data. Further, BNC210 holds a previously granted FDA fast-track designation for the acute treatment of SAD.

The upcoming Phase 3 clinical program, which is FDA-agreed and aligns with nonclinical toxicology studies required for registration, would begin dosing in 2024’s first quarter.

President and CEO Dr. Spyros Papapetropoulos says the team is “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.” 

The official results from the meeting held on Sept. 13 reflected agreement on:

• Conducting two randomized, placebo-controlled studies with a single administration of BNC210 during a public speaking task; 

• Using the Subjective Units of Distress Scale (SUDS) measured during a public speaking challenge as the primary efficacy endpoint; 

• To-be-explored doses of BNC210; 

• Sample size assumptions based on Phase 2 findings; 

• The design elements and size of the open-label safety study along with nonclinical toxicology studies toward supporting the new drug application (NDA).

• These outcomes, Papapetropoulos added, provide external and independent validation of the company’s stance on the strength and Phase 3-enabling nature of the Phase 2 dataset. “BNC210’s unique clinical profile seen in multiple anxiety disorders including SAD, Generalized Anxiety Disorder (GAD) and in a panic model, was recently significantly enhanced by the positive results in PTSD.”

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Photo: Benzinga edit with photo by Pexels.