#Canada #Montreal #Thryv Therapeutics #Long QT Syndrome #THRV-1268

Thryv Therapeutics Initiates Crucial Wave II Study for Long QT Syndrome Type 2

Thryv Therapeutics Inc., based in Montreal, has recently announced the launch of its Wave II clinical study, marking a significant progression in the research of Long QT Syndrome Type 2 (LQTS2). This Phase 2/3 study will focus on evaluating THRV-1268, an oral SGK1 inhibitor, specifically targeting adults diagnosed with this rare and often life-threatening condition.

Context for the Wave II Study

Long QT Syndrome, particularly Type 2, is a genetic disorder that leads to delayed cardiac repolarization, increasing the risk of severe arrhythmias and cardiac events. Currently, patients suffering from LQTS2 have limited treatment options, with no FDA-approved therapies available that directly address the root causes of QT prolongation. The urgency for effective treatment solutions has motivated Thryv to take this pivotal step towards potentially lifesaving interventions.

Dr. Amy Sehnert, Thryv's Chief Medical Officer, expressed enthusiasm about the Wave II study, stating, "This step represents a crucial advancement toward bringing THRV-1268 to those who need it most. The implications for patients with limited treatment options could be profound, as this study progresses toward establishing safer and more effective therapies."

Learnings from Previous Studies

The design of Wave II closely follows the insights gained from the Wave I clinical program, where the SGK1 inhibitor, LQT-1213, demonstrated promising results by significantly reducing QTc intervals in patients. These findings were further reinforced by subsequent Phase 1 studies of THRV-1268 that indicated its potential effectiveness in mitigating QT prolongation across multiple subtypes of Long QT Syndrome. As this new study unfolds, it stands to set critical benchmarks in both safety and efficacy for therapies focused on this condition.

Structure and Goals of Wave II

The Wave II study is structured into two parts: a 12-week dose-escalation phase (Part A) followed by a 6-week fixed-dose phase (Part B). This comprehensive approach aims to meticulously assess the mean change in QTc from baseline among the participants, specifically those with genetically confirmed LQTS Type 2 and elevated baseline QTc. The primary efficacy endpoint established centers on defining these changes over time, showcasing the precise nature of the trial’s objectives.

Community Involvement and Study Participation

Thryv Therapeutics encourages individuals and families impacted by Long QT Syndrome to engage with the study via social media platforms and the official Wave Studies website. It’s an essential opportunity for potential participants to understand how they might contribute to groundbreaking research while seeking novel treatment avenues.

In tandem with the Wave II clinical study, Thryv’s myQTwave program continues to monitor and document patient experiences and disease progression in individuals with LQTS2 and LQTS3, thereby providing a more comprehensive framework for enhancing treatment strategies.

Recruitment and Next Steps

Wave II will commence recruitment across various clinical study sites throughout the United States. The initial site will be led by Dr. Craig McCotter at Wilmington Health in North Carolina, with additional sites anticipated to follow. Full details about the study and recruitment process can be accessed through ClinicalTrials.gov and the designated Wave Studies website.

Conclusion

As Thryv Therapeutics embarks on this critical Wave II study, the implications for individuals suffering from Long QT Syndrome Type 2 cannot be overstated. This campaign may very well lay the foundation for future innovations in cardiac arrhythmia therapies, reigniting the hope for many who currently feel trapped by their condition. The biopharmaceutical industry stands on the cusp of potentially transformative therapies as Thryv pushes the boundaries of what's possible in the realm of inherited cardiac disorders.