The U.S. Food and Drug Administration (FDA) has cleared Thryv Therapeutics Inc.’s Investigational New Drug (IND) application for its lead compound, THRV-1268.
This enables Thryv to initiate the phase 2/3 WAVE II clinical study in long QT syndrome (LQTS) Type 2.
LQTS is a rare inherited cardiac arrhythmia condition characterised by delayed ventricular repolarisation, reflected on the electrocardiogram (ECG) as a prolonged QT interval. Prolongation of the QT interval increases the risk of torsades de pointes, a potentially life-threatening ventricular tachyarrhythmia. Individuals with LQTS are at greatest risk of arrhythmic events in response to physiological stressors such as exercise or emotional stress.
The three most common subtypes of congenital LQTS are Type 1, Type 2, and Type 3, each caused by distinct ion channel gene mutations that influence the specific triggers for arrhythmic events. In addition to the congenital forms, LQTS may also be acquired, most often due to exposure to medications that prolong the QT interval and similarly increase the risk of sudden cardiac death.
The phase 2/3 Wave II study will evaluate the safety and efficacy of THRV-1268 in patients with LQTS Type 2. The primary endpoint is the mean change from baseline in area under the curve corrected QT interval over six weeks of treatment in adult patients with a baseline QTc >480 milliseconds, regardless of background beta-blocker therapy.
In parallel with this regulatory milestone, Thryv secured new financing to initiate the Wave II clinical study.
This is the second IND clearance for Thryv in recent months, following FDA acceptance of an IND for THRV-1268 in heart failure and atrial fibrillation. Together, these regulatory achievements highlight the broad therapeutic potential of SGK1 inhibition across multiple serious cardiovascular diseases.
Thryv’s work with its first compound, LQT-1213, provided foundational non-clinical and clinical evidence supporting SGK1 inhibition in LQTS. THRV-1268 is being advanced as a best-in-class, optimised SGK1 inhibitor for LQTS, designed for long-term therapy in this chronic, life-threatening disease.
“This FDA clearance and the launch of the Wave II phase 2/3 study early next year represent major milestones in the development of what could become the first approved therapy for Long QT Syndrome,” said Paul Truex, chairman and CEO of Thryv Therapeutics.
“With strong investor support, Thryv is positioned to move rapidly into registration studies. Adults and children with LQTS deserve therapies that not only protect their lives but also allow them to live more fully—we are determined to deliver on that promise.”
Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.
