Thryv Therapeutics Inc. Announces Completion of Initial Phase 1 Clinical Study and Beginning of Proof of Efficacy Study in Long QT Syndrome
LQT-1213 was well tolerated with good bioavailability and predictable pharmacokinetics.
Mild concentration dependent reductions in QTcF were seen with a single dose of LQT-1213.
Proof of efficacy study in acquired Long QT Syndrome initiated: data in Q2.
Montreal, Quebec and Sarasota, Florida – March 14th, 2023
Thryv Therapeutics Inc., a clinical stage biotechnology company developing therapies for rare diseases including Congenital Long QT Syndrome (LQTS) and resistant cancers as well as atrial fibrillation announced today the completion of a healthy volunteer phase 1 clinical study with LQT-1213 - a potent and selective inhibitor of Serum Glucocorticoid inducible Kinase (“SGK”). Data from this study demonstrated escalating doses of LQT-1213 up to seven days were well tolerated with good oral bioavailability, favorable pharmacokinetics profile, and no significant adverse events. In healthy volunteers, LQT-1213 demonstrated encouraging mild concentration-dependent shortening of QTcF (QT interval using a Fredericia’s correction) directionally consistent with recently published reductions in action potential duration (APD90) in normalized cardiomyocytes derived from LQTS patient stem-cells. LQT-1213 was administered as an oral suspension with a low pH sports drink to provide insights for an eventual pediatric formulation – a key step to advance a therapy for children and young adults with LQTS.
The completion of this phase 1 clinical study is a major development milestone for Thryv Therapeutics as its portfolio of SGK inhibitors continues to expand and advance. Upregulation of SGK has been linked to adverse prolongation of the QTc interval. Inhibition of this stress activated kinase has repeatedly demonstrated the ability to shorten APD90 and the QTc interval in preclinical models of both Congenital and Acquired LQTS - both of which can lead to the development of lethal ventricular arrhythmias.
Shortly after the completion of the phase 1 study, dosing commenced in a Proof-of-Efficacy study (the “WAVE-I” study) to evaluate the ability of LQT-1213 to reduce QTc interval in individuals whose QTc is pharmacologically prolonged utilizing Tikosyn (dofetilde) – a known HERG blocking agent used for the treatment of atrial arrhythmias. Data from in vitro cardiomyocytes and animal models demonstrated a concentration-dependent reduction in both APD90 and QTc interval. The WAVE-I study will provide valuable dosing and efficacy data for LQT-1213 with the goal of initiating phase 3 clinical studies in LQTS type 2 and type 3 later this year.
“We are excited by the results from our initial phase 1 clinical study with LQT-1213 including excellent safety, tolerability, and a predictable pharmacokinetic profile with dosing up to seven days. We now will take the next steps to develop LQT-1213 for adults and children with Congenital LQTS - a patient population without an approved therapy,” said Philip Sager, MD, FAHA, FHRS, Co-founder and Chief Medical Officer of Thryv Therapeutics. “Our proof of efficacy study will be completed later in the second quarter of 2023 which could provide the first clinical validation of SGK inhibition in humans. We’re very excited about the potential of LQT-1213 to shorten the QTc in a meaningful manner such that our pivotal program will be substantially de-risked.”
About Thryv Therapeutics Inc.
Thryv Therapeutics Inc. (previously LQT Therapeutics Inc.) is a privately owned company based in Montreal, Quebec, Canada and Sarasota, Florida, USA. Thryv Therapeutics is pioneering a precision medicine approach to treat genetic and drug-induced Long QT Syndromes, atrial fibrillation, and resistant cancers with potent and selective inhibitors of Serum Glucocorticoid inducible Kinase. For more information, please visit www.thryvtrx.com
Media Inquiries
Daphne Doucet, Corporate Communications: daphne@thryvtrx.com +1 (514) 973 0915
