Sarepta and Hansa’s Gene Therapy Study: A Potential Breakthrough for DMD Treatment

Sarepta Therapeutics Inc. ((SRPT)), Hansa Biopharma ((SE:HNSA)) announced an update on their ongoing clinical study.

Study Overview: The clinical study titled ‘An Open-Label, Systemic Gene Delivery Study to Evaluate the Safety, Tolerability and Expression of SRP-9001 in Association With Imlifidase in Subjects With Duchenne Muscular Dystrophy With Pre-existing Antibodies to rAAVrh74’ aims to assess the safety and efficacy of the gene therapy delandistrogene moxeparvovec (SRP-9001) when used alongside imlifidase. This study is significant as it targets Duchenne Muscular Dystrophy (DMD) patients who have pre-existing antibodies to the viral vector used in the therapy, potentially expanding treatment options for this group.

Intervention/Treatment: The study tests two interventions: delandistrogene moxeparvovec, a genetic therapy delivered via a single IV infusion, and imlifidase, a biological agent also administered intravenously. The purpose is to enable effective gene therapy in patients with pre-existing antibodies.

Study Design: This is an interventional, open-label, single-group study with no masking. The primary purpose is treatment, focusing on evaluating the safety and expression of the genetic therapy in the specified patient group.

Study Timeline: The study began on January 26, 2024, and the last update was submitted on February 28, 2025. These dates are crucial for tracking the study’s progress and anticipating future updates or results.

Market Implications: The progress of this study could positively influence Sarepta Therapeutics and Hansa Biopharma’s stock performance by demonstrating advancements in treating DMD, a challenging condition. Successful outcomes may enhance investor sentiment and position these companies favorably against competitors in the gene therapy space.

The study is ongoing, with further details available on the ClinicalTrials portal.