(RTTNews) - Pure Tech Health (PRTC) said the U.S. FDA has completed its End-of Phase 1 review of LYT-200 and granted the experimental therapy Fast Track designation for the treatment of relapsed/refractory high-risk myelodysplastic syndromes.
Myelodysplastic syndrome (MDS), is a serious blood cancer with limited treatment options.
The FDA feedback supports moving LYT-200 into a Phase 2 study, marking an important regulatory milestone for the therapy. Fast Track designation is intended to help speed the development and review of medicines that address serious conditions and unmet medical needs.
LYT-200 is being developed by Gallop Oncology, a founded entity of PureTech. The therapy targets galectin-9, a protein that the company says can help tumors evade the immune system and promote cancer growth. The treatment is being evaluated in combination with hypomethylating agent (HMA), which are commonly used therapies for myelodysplastic syndromes.
Myelodysplastic syndromes are a group of blood disorders in which the bone marrow does not produce enough healthy blood cells. Patients with high-risk disease face an increased likelihood of progression to acute myeloid leukemia, making new treatment options particularly important.
According to PureTech, FDA feedback from the End-of-Phase 1 meeting provides a clear path for advancing LYT-200 into Phase 2 development. The company plans to evaluate whether the treatment can build on encouraging clinical activity observed in an earlier Phase 1b study.
The upcoming Phase 2 trial, known as STRIDE-MDS, will be a randomized, double-blind placebo-controlled study enrolling approximately 125 patients with relapsed or refractory high-risk myelodysplastic syndromes. Participants will receive one of two doses of LYT-200 plus an HMA, or placebo plus an HMA. The study will assess treatment efficacy by measuring complete and partial response rates and will also help determine the optimal dose for later-stage development.
PureTech said the trial design incorporates two dose levels to align with the FDA's Project Optimus initiative, which aims to improve dose selection in oncology drug development.
The company believes LYT-200's mutation-agnostic approach could potentially benefit a broad range of patients with relapsed or refractory high-risk MDS, regardless of specific genetic mutations.
Looking ahead, PureTech said its plans to secure external funding through Gallop Oncology to support continued development of LYT-200 through completion of the Phase 2 program, with capital raising efforts expected in the first half of 2027.
The regulatory update represents another step forward for PureTech's oncology pipeline as the company seeks to advance LYT-200 toward later-stage clinical testing.
PRCT has traded between $14.50 and $19.92 over the past year. The stock closed Friday's trading at $16.00 down 3.03%.