Phio Pharmaceuticals Corp. (Nasdaq: PHIO) announced on September 14, 2026, that it has submitted a comprehensive briefing package to the U.S. Food and Drug Administration (FDA) to support the next phase of clinical development for its lead candidate, PH-762.
The submission follows the formal completion of the Phase 1b clinical study for PH-762. The briefing package includes data on the nonclinical development program, integrated clinical pharmacology, and details regarding the completed Phase 1b trial. It also outlines the scientific rationale, study design, and pharmacokinetic strategy for a planned Phase 2b neoadjuvant study in cutaneous squamous cell carcinoma.
Robert J. Bitterman, President and CEO of Phio Pharmaceuticals, stated that submitting the briefing package is a key achievement for the PH-762 program. He noted that the company is encouraged by the Phase 1b findings and looks forward to working with the FDA.
Phio is currently preparing to manufacture clinical supplies for the next planned study, which are expected to be available in the first quarter of 2027. Additionally, the dosing phase of the company's nonclinical toxicology study has been completed. Final activities supporting the next phase of clinical development are expected to be finished during the first quarter of 2027.
The Phase 1b trial, identified by NCT# 06014086, evaluated PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma. PH-762 is an INTASYL compound designed to silence the PD-1 gene, which is implicated in various forms of skin cancer.
