Phio Pharmaceuticals Reports Stronger Phase 1b PH-762 Results: 85% Response in Final Cohort, Clean Safety
Summary
Phio Pharmaceuticals announced a positive wrap-up from its Safety Monitoring Committee for the Phase 1b trial of PH-762, reporting an 85% pathological response in the final cohort and a clean safety profile.
Key Events
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Positive Safety Conclusion for PH-762
The Safety Monitoring Committee formally concluded its review for the Phase 1b clinical trial of PH-762, reporting no dose-limiting toxicities or serious adverse events across all five dose escalation cohorts and 22 enrolled patients.
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High Efficacy in Final Dose Cohort
The maximum dose concentration in the final cohort yielded an 85% pathological response (6 of 7 patients), with 4 of 6 responders achieving complete response (100% tumor clearance).
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Overall Response Rate for cSCC
Revised data supports an overall response rate of 65% for squamous cell carcinomas (cSCC), with 13 of 20 cSCC patients classified as pathologic responders, including 9 with complete response.
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Next Steps for Clinical Development
The company targets an FDA submission in Q2 2026 to propose and seek guidance for the next clinical study design for PH-762, with manufacturing of cGMP material expected in H2 2026.
Analysis
Phio Pharmaceuticals has announced highly positive and more detailed results from its Phase 1b clinical trial for PH-762 in skin cancer, building on the positive data reported on January 20, 2026. The Safety Monitoring Committee's formal conclusion confirms a favorable safety profile with no serious adverse events or dose-limiting toxicities across all dose escalation cohorts. Crucially, the highest dose concentration in the final cohort demonstrated an 85% pathological response rate, with 100% tumor clearance in a significant portion of responders. These robust efficacy and safety findings are critical for a clinical-stage biopharmaceutical company, providing strong validation for its lead candidate and supporting its planned FDA submission for next-stage clinical study design.
At the time of this filing, PHIO was trading at $1.04 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $9.7M. The 52-week trading range was $0.81 to $4.19. This filing was assessed with positive market sentiment and an importance score of 8 out of 10.