Thryv Therapeutics secures FDA IND clearance for THRV-1268 in Long QT Syndrome
Thursday, September 18, 2025
Thryv Therapeutics Inc., a clinical-stage biotechnology company developing serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for cardiovascular diseases, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application of THRV-1268. This approval allows the company to begin the Phase 2/3 WAVE II clinical study in Long QT Syndrome (LQTS) Type 2.
The study will assess the safety and efficacy of THRV-1268 in adult patients with LQTS Type 2 who have a baseline QTc above 480 milliseconds, with or without beta-blocker therapy. The primary endpoint is the mean change from baseline in QTc area under the curve (0-6)/6 after six weeks of treatment.
Alongside this milestone, Thryv has secured new financing to support the Wave II study. The investment comes from Amplitude Ventures, Fonds de solidarité FTQ, Lumira Ventures, Investissement Québec, adMare BioInnovations, and CTI Life Sciences Fund, providing capital strength to advance THRV-1268 through late-stage clinical development.
This is the company’s second recent IND clearance, following FDA acceptance of an application for THRV-1268 in heart failure and atrial fibrillation. Together, these developments highlight the broad therapeutic potential of SGK1 inhibition across cardiovascular conditions.
THRV-1268 builds on earlier work with Thryv’s first compound, LQT-1213, which provided preclinical and clinical evidence supporting SGK1 inhibition in LQTS. The new therapy is being developed as a best-in-class, optimised SGK1 inhibitor designed for long-term treatment in this chronic, life-threatening disease.
Source: prnewswire.com
