Hamlet BioPharma Completes Phase II Study of Alpha1H for Bladder Cancer

Hamlet BioPharma announced the conclusion of its Phase II clinical trial for Alpha1H, a drug candidate developed for the treatment of non-muscle invasive bladder cancer. The company has submitted the final clinical study report to the U.S. Food and Drug Administration (FDA).

The study demonstrated significant treatment effects, meeting all primary and secondary endpoints related to safety and efficacy. According to the final report, 80% of tumors responded to Alpha1H treatment, with an average tumor size reduction of 59% observed in the high-dose group.

Further findings included evidence of durable effects across repeated treatment cycles. The therapy also triggered an immune response comparable to BCG, the current standard of care, but with faster onset and without lasting side effects. Advanced RNA sequencing revealed that Alpha1H downregulated over 700 cancer-related genes.

The safety profile of Alpha1H was confirmed, with no drug-related serious adverse events reported, even after higher or repeated dosing. Mild local side effects were reported as comparable to placebo, supporting the drug's localized mechanism of action.