Myosin Therapeutics Inc, a clinical-stage biotechnology company developing first-in-class therapies that modulate molecular motor proteins, announced on Wednesday that the US Food and Drug Administration (FDA) has granted Fast Track designation to MT-125 for the treatment of glioblastoma (GBM).

Fast Track is an FDA programme designed to facilitate development and expedite review of drugs that treat serious conditions and address unmet medical needs. This designation benefits patients and drug sponsors by enabling more frequent interactions with the FDA and providing eligibility for rolling review of a marketing application.

"Receiving Fast Track designation validates our conviction that MT-125 has the potential to offer an entirely novel treatment approach to patients with even the most aggressive forms of glioblastoma," said Dr. Courtney Miller, Myosin Therapeutics' CEO. "We are energised by the open communication with the FDA that the Fast Track offers because it will ensure we advance MT-125 as quickly as possible with our patient-centred approach."

MT-125 is a first-in-class dual inhibitor of non-muscle myosin IIA and IIB (NMIIA/IIB). According to Myosin Therapeutics, it brings a completely new mechanism of action to a disease where decades of limited progress has built anticipation for genuine therapeutic innovation. By leveraging GBM biology research focused on targeting the cellular nanomotor proteins driving tumour cells, MT-125 enables simultaneous tackling of the proliferative and invasive phenotypes of this aggressive primary brain tumour, while improving the efficacy of radiation.

A Phase 1/2 trial evaluating safety, pharmacokinetics, and preliminary activity has been cleared to proceed. The FDA previously granted Orphan Drug Designation to MT-125 for malignant gliomas, including GBM.