Hamlet BioPharma achieved a significant regulatory milestone on June 24, 2025, with its first in-person meeting with the U.S. Food and Drug Administration yielding a clear pathway to Phase III trial initiation for its bladder cancer treatment Alpha1H. The pharmaceutical company, which specializes in developing drugs for cancer and infections, received positive feedback that positions the program for late-stage clinical development.
FDA Endorses Phase II Results
The Hamlet team presented data from their recently completed Phase II study, which concluded in December 2024, during the regulatory meeting. According to the company, the impressive data from the Alpha1H program was well-received by the FDA, providing a strong foundation for advancing to Phase III development.
"We appreciate the FDA's engagement and valuable feedback as we continue the late-stage development of Alpha 1H and the treatment of Bladder Cancer," commented Catharina Svanborg, CEO of Hamlet Biopharma. "This meeting brings us one step closer to delivering a new treatment option for patients facing bladder cancer."
Phase III Trial Design Guidance
The discussion with FDA regulators focused on trial design for non-muscle invasive bladder cancer (NMIBC) patients, with the agency providing helpful feedback that will support Alpha1H registration. The meeting included participation from Hamlet's clinical team in Prague and regulatory expertise from Target Health, demonstrating a collaborative approach to the development program.
Adam Harris, MM, RAC, from Target Health, who served as regulatory lead for the FDA meeting, congratulated the Hamlet team on the successful outcome. The regulatory guidance received will now be incorporated into Hamlet BioPharma's Phase III protocol development.
Path to Market Approval
The company remains on track to initiate the Phase III trial, subject to final protocol agreement and regulatory clearance. The meeting marked a key milestone in the regulatory pathway and provided an opportunity to align with the FDA on critical aspects of the trial design that will ultimately support market approval.
The successful FDA interaction represents a significant advancement for Alpha1H, positioning the treatment as a potential new therapeutic option for bladder cancer patients. The clear regulatory pathway established through this meeting demonstrates the FDA's confidence in the program's clinical data and development strategy.
