PureTech Health (LSE:PRTC), the hub-and-spoke biotherapeutics company, said its Founded Entity Gallop Oncology has completed a successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration for LYT-200.
The regulator granted Fast Track designation for the drug, used in combination with a hypomethylating agent, in relapsed/refractory high-risk myelodysplastic syndromes (R/R HR-MDS).
The designation clears the path to STRIDE-MDS, a randomised, double-blind Phase 2 trial enrolling roughly 125 patients, split 2:2:1 between two LYT-200 doses plus a hypomethylating agent and a placebo arm.
PureTech intends to raise external capital in the first half of 2027 to fund the trial through completion via Gallop Oncology.
LYT-200 targets galectin-9, a protein PureTech describes as both an oncogenic driver and immunosuppressor, and takes a mutation-agnostic approach designed to reach a broader patient population than genetically targeted therapies.
The programme is backed by Phase 1b data in heavily pretreated R/R HR-MDS patients, where the 12 mg/kg combination arm produced a 45.5% overall response rate and an 18% conversion rate to transplant, with no dose-limiting toxicities.
"Our productive End-of-Phase 1 meeting with the U.S. FDA provides a clear path to advance LYT-200 into Phase 2 development," said Eric Elenko, Acting Chief Executive Officer of Gallop Oncology and PureTech co-founder.
Yale Cancer Center's Amer Zeidan, who will serve as global principal investigator for STRIDE-MDS, noted that fewer than 5% of these patients typically respond to HMA rechallenge, underscoring the unmet need the trial aims to address.
News Intelligence what this means for the company
PureTech's Gallop Oncology cleared its End-of-Phase 1 meeting and secured FDA Fast Track designation for LYT-200 in relapsed/refractory high-risk myelodysplastic syndromes, unlocking a Phase 2 trial (STRIDE-MDS) in roughly 125 patients. The designation is a regulatory de-risking milestone; Phase 1b data showed a 45.5% overall response rate in the 12 mg/kg combination arm with no dose-limiting toxicities, addressing an unmet need where fewer than 5% of these patients respond to hypomethylating agent rechallenge. The company plans to raise external capital in H1 2027 to fund the trial through completion.
Fast Track status accelerates the regulatory pathway and signals FDA confidence in the programme's clinical rationale, reducing development risk for this oncology asset. However, as a pre-revenue clinical-stage company, PureTech remains dependent on the planned H1 2027 capital raise to fund STRIDE-MDS completion, and Phase 2 trial success is not assured.
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