Relay Therapeutics Inc. (RLAY) announced initial clinical results from its ongoing Phase 2 ReInspire trial of Zovegalisib, showing encouraging efficacy and safety in patients with PIK3CA-driven vascular anomalies.
Vascular anomalies are rare disorders caused by mutations in the PIK3CA gene, leading to abnormal blood vessel growth that can result in pain, swelling, and functional impairment. Current treatment options are limited, highlighting the need for new targeted therapies.
At the 12-week assessment, 60% of patients achieved volumetric lesion reduction, with responses observed across multiple dose levels and mutation types. Nearly all patients experienced symptomatic improvements, and investigator- and patient-reported outcomes indicated clinical benefit in 89% and 79% of patients, respectively.
The interim safety profile supported chronic dosing, with no treatment discontinuations due to adverse events. Common side effects were manageable and reversible, and no severe rash, stomatitis, or high-grade hyperglycemia was reported.
"These data demonstrate, for the first time, the promise of PI3Ka mutant-selective inhibition for patients with vascular anomalies," said Don Bergstrom, M.D., Ph.D., President of R&D at Relay Therapeutics, noting the potential to change the treatment paradigm for this underserved population.
The ReInspire study is enrolling adults, adolescents, and pediatric patients across dose-finding and expansion cohorts. Zovegalisib is also being investigated in Phase 3 breast cancer trials and other PI3Ka-mutated indications.
Relay presented the data at the ISSVA World Congress 2026 in Philadelphia and will host a conference call today to discuss the results.
RLAY has traded between $2.75 and $17.32 over the past year. The stock closed Monday's trading at $12.10, down 0.82%. In pre-market trading the stock is at $13.75, up 13.67%.
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