First PRIZM Study Participant Enrolled in Tisento Therapeutics’ Open-Label Extension Study in MELAS
Participants Who Complete Treatment in Global Phase 2b PRIZM MELAS Study Are Eligible to Enroll
Excerpt from the Press Release:
CAMBRIDGE, Mass., Aug. 20, 2025 (GLOBE NEWSWIRE) — Tisento Therapeutics today announced that the first participant has enrolled in the company’s open-label extension study in MELAS (Mitochondrial Encephalomyopathy, Lactic Acidosis, and Stroke-like Episodes). The extension study (NCT06961344) is evaluating the long-term safety and tolerability of zagociguat in individuals with MELAS who complete treatment in the global Phase 2b PRIZM study, which is expected to complete screening in the next months. The extension study is intended to provide uninterrupted access to zagociguat for clinical trial participants for up to two years and evaluate the long-term safety of zagociguat.
“We’re pleased to reach the important milestone of enrolling the first PRIZM study participant into our open-label extension study,” said Peter Hecht, Ph.D., chief executive officer of Tisento. “Enthusiastic engagement by MELAS patients and physicians is powering momentum in our development program, and we look forward to completing PRIZM enrollment in the next few months.”
The PRIZM study is actively enrolling in the U.S., Canada, Australia, United Kingdom, Italy, and Germany, and interested individuals are encouraged to discuss participation with their physician. PRIZM is evaluating the impact of zagociguat treatment on fatigue, cognitive performance, and other key aspects of MELAS.
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