Thryv Therapeutics Commences Patient Dosing in Wave II Clinical Study for Long QT Syndrome and Receives FDA Fast Track Designation for THRV-1268
Patient dosing commenced in Wave II, a multicenter Phase 2/3 study evaluating THRV-1268 in genetically confirmed Long QT Syndrome (LQTS) Type 2; enrollment at leading centers throughout the United States is advancing on track.
FDA Fast Track Designation granted for THRV-1268 in LQTS Type 2 and Type 3, supporting expedited development of an investigational therapy targeting QTc reduction and arrhythmic risk in genetically defined LQTS populations.
San Francisco, California – April 22, 2026 – Thryv Therapeutics Inc., a clinical-stage biotechnology company advancing novel serum glucocorticoid inducible kinase 1 (SGK1) inhibitors for inherited cardiac arrhythmias, cardiometabolic diseases, and cardiomyopathies, today announced key development milestones for its THRV-1268 clinical program: patient dosing has commenced in the Phase 2/3 Wave II clinical study evaluating THRV-1268 in patients with genetically confirmed Long QT Syndrome Type 2, and the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to THRV-1268 for the treatment of Long QT Syndrome Type 2 and Type 3. Enrollment of the Wave II study remains on track with the company’s expectations for delivering initial data in the fourth quarter of 2026.
Commencement of Patient Dosing in Wave II Phase 2/3 Clinical Study
Enrollment at leading inherited arrhythmia centers across the United States is under way for the Wave II clinical study (NCT07277582). Wave II is a multicenter, Phase 2/3 trial enrolling patients with genetically confirmed Long QT Syndrome Type 2. The primary endpoint will assess the safety and efficacy of two dose levels of THRV-1268 over a 12-week period, measured by change in QTcF over six hours, together with evaluations of cardiac rhythm stability, safety, and tolerability.
Professor Vasanth Vedantham, MD, PhD, at UCSF Health in San Francisco, California, initiated the first of fourteen patients planned in Part A of the Wave II study.
"The emerging clinical evidence for SGK1's role in cardiac electrophysiology gives me hope that we may finally have a new approach to Long QT Syndrome that addresses the underlying QT interval prolongation. Initiating Wave II is a meaningful step forward for the potential treatment of patients living with Long QT Syndrome Type 2. Patients and their families carry an enormous burden – not just the medical complexity of managing arrhythmic risk, but the emotional weight of living with a condition that remains life-threatening despite current therapies," said Vasanth Vedantham, MD, PhD, Professor of Medicine, Cardiac Electrophysiologist and Shashi and Dipanjan (DJ) Deb Endowed Professor in Cardiovascular Genetics, UCSF Health.
Initially, participants in the Wave II study will receive the study drug as an oral suspension, selected to accelerate data collection for the pediatric formulation, for 12 weeks, with the option to transition to an adult tablet and continue therapy for up to one year.
FDA Fast Track Designation
Fast Track Designation is intended to facilitate the development and expedited review of investigational therapies that address serious conditions with unmet medical needs. The designation enables more frequent interactions with the FDA and, if relevant criteria are met, potential eligibility for Rolling Review, Priority Review, and Accelerated Approval.
“Fast Track Designation represents a meaningful regulatory milestone that reflects the serious and underserved nature of genetically defined Long QT Syndrome,” said Amy Sehnert, MD, FACC, Chief Medical Officer of Thryv Therapeutics. “This recognition by the FDA reinforces our confidence in THRV-1268 and its potential to become the first disease-modifying therapy to specifically target the underlying disease biology of Long QT Syndrome. We are committed to working closely with the Agency as enrollment in the Wave II clinical study advances.”
For more information, visit www.clinicaltrials.gov or www.wavestudies.com/wave-2.
About Thryv Therapeutics
Thryv Therapeutics Inc. is pioneering a precision medicine approach to treating genetic arrhythmia syndromes and cardiometabolic diseases through potent and highly selective inhibitors of serum glucocorticoid inducible kinase 1 (SGK1). For more information, please visit www.thryvtrx.com.
Disclaimer
The information stated above was prepared by Thryv Therapeutics and reflects solely the opinion of Thryv Therapeutics. Nothing in this statement shall be construed to imply any support or endorsement of Thryv Therapeutics, or any of its products, by the Regents of the University of California, its officers, agents and employees. Dr. Vedantham will not receive compensation from Thryv Therapeutics.
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