Myosin Therapeutics Receives FDA Clearance To Initiate First-in-Human Trial of MT-125 in Glioblastoma

UF startup Myosin Therapeutics, Inc., a clinical-stage biotechnology company developing first-in-class therapies targeting molecular motors, announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for MT-125. The active IND allows the company to initiate a Phase 1 study to evaluate MT-125 in combination with standard of care radiation in patients with newly diagnosed IDH wild type, MGMT unmethylated glioblastoma. This subset of patients faces a particularly poor prognosis due to limited responsiveness to current chemotherapy.

MT-125 is a selective inhibitor of non-muscle myosin II (NMII), a molecular motor protein that drives tumor proliferation and invasion, resistance to therapy and oxidative stress, and immune evasion. By specifically targeting NMII, MT-125 is designed to disrupt these critical mechanisms of glioblastoma progression. In preclinical models, MT-125 demonstrated potent anti-tumor activity and enhanced the efficacy of radiotherapy.

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