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Relay Therapeutics Announces Initial Clinical Data Demonstrating That Zovegalisib Has Potential for Differentiated Safety and Efficacy in Patients with PIK3CA-Driven Vascular Anomalies
Promising initial efficacy data with 60% volumetric response rate across doses and 29%* at the lowest tested dose of 100mg twice daily (BID) with all patients
About this update from Relay Therapeutics, Inc.
[{"type":"text","content":"Promising initial efficacy data with 60% volumetric response rate across doses and 29%* at the lowest tested dose of 100mg twice daily (BID) with all patients ongoing Interim investigator- and patient-reported outcomes show 89% and 79% of patients achieved clinical improvement at week 12, respectively, and support the potential of zovegalisib to drive clinically meaningful benefit for patients Evaluation across a wide dose range confirms potential therapeutic window, with interim safety profile supportive of chronic dosing and no patients discontinuing treatment due to adverse events Expansion cohorts for adults and adolescents opened at 400mg once daily (QD) and 300mg BID;pediatric dose-finding is ongoing Company to host conference call today, Tuesday, May 19, 2026 at 8:00 am ET CAMBRIDGE, Mass., May 19, 2026 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage, small molecule precision medicine company developing potentially life-changing therapies for patients living with cancer and genetic disease, today announced initial clinical data from the Phase 2 ReInspire trial of zovegalisib in vascular anomalies signaling the advantage of PI3Kα mutant-selective inhibition. Vascular anomalies are a group of rare disorders characterized by abnormal development of blood vessels, lymphatic vessels and surrounding tissues. As of the April 15, 2026 data cut-off date, in the Part 1 dose randomization portion of the study for adults and adolescents ages 12 and up, 60% of patients achieved a volumetric response at the earliest time point (12 weeks) and nearly all patients experienced symptomatic improvement at 12 weeks while maintaining a safety and tolerability profile showing the potential for chronic use. The data are being presented at the International Society for the Study of Vascular Anomalies (ISSVA) World Congress 2026, taking place in Philadelphia. “These data demonstrate, for the first time, the promise of PI3Kα mutant-selective inhibition for patients with vascular anomalies,” said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics. “The combination of robust volumetric responses, symptomatic improvement, and a safety profile that supports chronic dosing underscores the potential of zovegalisib to meaningfully change the treatment paradigm for this underserved population. These early resul...