islasertib (LQT-1213) / Thryv Therap - LARVOL DELTA

LQT-1213-0061: Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2). (clinicaltrials.gov) - P1/2 | N=42 | Terminated | Sponsor: Thryv Therapeutics, Inc. | N=28 ➔ 42 | Active, not recruiting ➔ Terminated; Advancing an alternative SGK1 inhibitor.

Enrollment change • Trial termination • Cardiovascular • KCNH2

LQT-1213-0061: Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 1, 2 or 3 Long QT Syndrome (Part 2). (clinicaltrials.gov) - P1/2 | N=28 | Active, not recruiting | Sponsor: Thryv Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • KCNH2

Thryv Therapeutics Granted FDA Orphan Drug Designation for LQT-1213 in Long QT Syndrome Treatment (PRNewswire) - "Thryv Therapeutics...announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to LQT-1213 for the treatment of Long QT Syndrome (LQTS). LQT-1213 is a novel, first-in-class SGK1 inhibitor specifically designed to treat congenital LQTS. Thryv has developed a series of SGK1 inhibitors for the treatment of cardiometabolic stress associated with various arrhythmic diseases including LQTS, atrial fibrillation, and heart failure."

Orphan drug • Cardiovascular

LQT-1213-0061: Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 1, 2 or 3 Long QT Syndrome (Part 2). (clinicaltrials.gov) - P1/2 | N=28 | Recruiting | Sponsor: Thryv Therapeutics, Inc. | Trial completion date: Jun 2024 ➔ Feb 2025 | Trial primary completion date: Jun 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • KCNH2

SGK1 INHIBITOR LQT-1213 SIGNIFICANTLY ATTENUATES DOFETILIDE-INDUCED QT PROLONGATION IN HUMANS: RESULTS OF THE WAVE I CLINICAL STUDY (ACC 2024) - "Treatment with LQT-1213 significantly reduced DOF-induced QT prolongation, without safety issues. The WAVE I study provides evidence that the SGK1 inhibitor LQT-1213 could shorten the QT intervals in patients with LQTS and drug induced QT prolongation, providing proof of concept for a novel, mechanistic-based targeted therapy ."

Clinical • Atrial Fibrillation • Cardiovascular

Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2). (clinicaltrials.gov) - P1/2 | N=28 | Recruiting | Sponsor: Thryv Therapeutics, Inc. | Phase classification: P1b/2a ➔ P1/2 | Trial completion date: Feb 2024 ➔ Jun 2024 | Trial primary completion date: Feb 2024 ➔ Jun 2024

Phase classification • Trial completion date • Trial primary completion date • KCNH2

Study of LQT-1213 on Dofetilide-Induced QTc Prolongation in Healthy Adult Subjects and Patients Diagnosed With Type 2 or 3 Long QT Syndrome (clinicaltrials.gov) - P1b/2a | N=28 | Recruiting | Sponsor: Thryv Therapeutics, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • KCNH2

Phase 1 Study of LQT-1213 in Healthy Adults (clinicaltrials.gov) - P1 | N=50 | Completed | Sponsor: Thryv Therapeutics, Inc.

New P1 trial