WILMINGTON, DE — Prelude Therapeutics Incorporated (Nasdaq: PRLD) said the U.S. Food and Drug Administration has cleared its investigational new drug application for PRT12396, allowing the company to begin a Phase 1 clinical study of the experimental therapy in patients with certain myeloproliferative neoplasms.
The company said it expects to dose the first patient by the second quarter of 2026. PRT12396 is a mutant-selective inhibitor targeting JAK2V617F, a genetic mutation that drives disease progression in most patients with myeloproliferative neoplasms, including polycythemia vera and myelofibrosis.
Chief Executive Officer Kris Vaddi said the FDA decision represents a major milestone in the company’s shift toward advancing its JAK2 and KAT6 programs. He said the clearance reflects Prelude’s ability to move scientific discoveries into clinical development and advances programs aimed at changing treatment options for patients with limited alternatives.
The Phase 1 study will be an open-label, multi-center trial evaluating safety, efficacy, and pharmacokinetics in patients with high-risk polycythemia vera and intermediate- to high-risk myelofibrosis.
Prelude said the JAK2V617F program is covered by an exclusive option agreement with Incyte that was announced in November 2025.
JAK2V617F is the primary driver mutation in a majority of patients with myeloproliferative neoplasms, affecting about 95 percent of patients with polycythemia vera, 60 percent of those with essential thrombocythemia, and 55 percent of patients with myelofibrosis. Prelude said it has developed novel allosteric inhibitors designed to selectively target cells carrying the mutation, with the potential to reduce mutant allele burden and slow or reverse disease progression.
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