The US Food and Drug Administration has granted Fast Track Designation to LYT-200 in combination with a hypomethylating agent for the treatment of patients with relapsed/refractory high-risk myelodysplastic syndromes, according to PureTech Health, the developer of the drug.
LYT-200 is a first-in-class monoclonal antibody that targets galectin-9 to selectively eliminate disease-driving cells across a broad population of patients who lack actionable mutations, according to the company.
The designation follows a successful end-of-phase 1 meeting with the FDA and is supported by positive data showing clinical efficacy and a consistent safety profile in heavily pretreated patients, according to a press release from PureTech Health.
Feedback from the FDA supports advancing the therapy into STRIDE-MDS, a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating the efficacy, safety, and dose selection of LYT-200.
“Patients with higher-risk MDS who relapse or become refractory to HMA treatment have very limited therapeutic options and poor outcomes, and the literature and clinical practice suggest that fewer than 5% of these patients typically respond to retreatment with an HMA rechallenge,” said Amer Zeidan, MBBS, MHS, professor of medicine at Yale University and chief of the Division of Hematologic Malignancies at Yale Cancer Center, who will be the global principal investigator of the phase 2 STRIDE-MDS trial. “Against this backdrop, the clinical activity observed with LYT-200 in combination with an HMA in the Phase 1b study is particularly encouraging. STRIDE-MDS will allow us to further evaluate this activity in a randomized, placebo-controlled study.”
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