Phio Pharmaceuticals submitted FDA materials supporting a planned Phase 2b neoadjuvant study for PH-762 after completing its Phase 1b trial. The package covers development data and study design, while clinical supplies and remaining preparation are expected in the first quarter of 2027, defining the program’s next stated steps.

Key Highlights

  • Phio Pharmaceuticals completed the dosing phase of its nonclinical toxicology study for PH-762.
  • The FDA submission covers PH-762’s nonclinical development program, integrated clinical pharmacology data and completed Phase 1b study.
  • The proposed Phase 2b neoadjuvant study includes its scientific rationale, design and pharmacokinetic strategy.
  • Clinical supplies and remaining development activities are expected to be ready or conclude in the first quarter of 2027.

FDA Package Sets Out PH-762 Phase 2b Plan

The submission covers PH-762’s nonclinical development program, integrated clinical pharmacology data and completed Phase 1b study. It also details the proposed Phase 2b neoadjuvant study, including its scientific rationale, design and pharmacokinetic strategy. Robert J. Bitterman, the company’s president and chief executive officer, described the submission as a key development milestone for the program.

Preparation Extends Into First Quarter of 2027

Phio (NASDAQ: PHIO) is preparing clinical supplies for the next planned study, with availability expected in the first quarter of 2027. The dosing portion of its nonclinical toxicology study has been completed, while remaining activities supporting the next development stage are also expected to conclude during the first quarter of 2027. Phio plans to work with the FDA on potential next steps involving PH-762’s clinical trial design and development.