Hamlet BioPharma conducts pre-initiation visit in Prague for Phase III bladder cancer trial
Hamlet BioPharma AB conducted a pre-initiation visit in Prague, Czech Republic, for the upcoming Phase III clinical trial of its Alpha1H drug. The visit focused on collaboration with Charles University.
LUND, SWEDEN – Hamlet BioPharma AB announced on June 17, 2026, that a pre-initiation visit was conducted in Prague, Czech Republic, in preparation for a forthcoming Phase III clinical trial. The study will evaluate the company's drug candidate, Alpha1H, for the treatment of non-muscle-invasive bladder cancer (NMIBC).
The visit took place at the Department of Urology at Charles University, led by Professor Marek Babjuk, a prominent international expert in bladder cancer therapy. Professor Babjuk's group previously led a successful Phase II study assessing Alpha1H in NMIBC patients. Prague is recognized as a significant center for bladder cancer research, and the collaboration with Hamlet BioPharma and Lund University is well-established.
Bladder cancer represents a substantial unmet medical need and a costly disease in the U.S., largely due to high rates of recurrence and progression. Current treatments do not entirely eliminate the risk of recurrence for patients, creating a need for less toxic therapeutic options. The Phase III study is founded on a comprehensive scientific and clinical evaluation, including reviews of published clinical data by the U.S. Food and Drug Administration (FDA).
"We believe the treatment potential of Alpha1H to improve patient outcomes is significant, and we look forward to exploring its potential in the neoadjuvant setting," stated Professor Babjuk. Hamlet BioPharma views the Phase III trial as a crucial step in strengthening the commercial potential and future market opportunities for Alpha1H.