Hansa Biopharma Announces Positive Data for Enabling Duchenne Muscular Dystrophy Gene Therapy

LUND, Sweden – August 1, 2025 – Hansa Biopharma AB (Nasdaq Stockholm: HNSA) today announced positive topline results from a trial assessing its antibody-cleaving enzyme, imlifidase, in three patients with Duchenne muscular dystrophy (DMD). The treatment successfully reduced pre-existing antibodies, allowing these patients to receive Sarepta’s gene therapy, ELEVIDYS (delandistrogene moxeparvocec-rokl).

The SRP-9001-104 trial demonstrated that a single dose of imlifidase led to a rapid and substantial reduction of IgG antibodies, with levels dropping by at least 95% from baseline. Crucially, pre-existing anti-AAV antibodies were reduced below the 1:400 threshold, which enabled the patients to proceed with the ELEVIDYS gene therapy.

“These are the first results from a clinical trial assessing imlifidase’s potential for patients with high levels of anti-AAV antibodies to access approved gene therapies,” said Renée Aguiar-Lucander, CEO of Hansa Biopharma. “We are encouraged that imlifidase was able to substantially reduce both IgG antibodies and pre-existing anti-AAV-antibodies to enable patients to be treated with gene therapy.”

The safety profile of imlifidase was consistent with prior experience, and no new safety signals were observed in the trial. Twelve weeks after the ELEVIDYS administration, the patients showed evidence of AAV-mediated transduction and expression of micro-dystrophin, though at lower levels compared to those seen in other ELEVIDYS trials.

Based on these outcomes, Hansa and Sarepta will now discuss the appropriate next steps for the program. Hansa Biopharma also noted it will report data from another ongoing gene therapy collaboration later this year, continuing to build evidence for imlifidase’s potential benefits in the gene therapy space.