After one dose of imlifidase, three patients experienced a rapid reduction of IgG antibodies, to levels ≥95% less than baseline. In addition, in these three patients pre-existing anti-AAV antibodies were reduced below a titre of 1:400, which enabled treatment with ELEVIDYS.

The safety profile of imlifidase was in keeping with prior experience and the trial did not generate any new safety signals.

Twelve weeks after administration of the gene therapy, patients in the trial demonstrated evidence of AAV-mediated transduction and expression of micro-dystrophin, however with levels lower than seen in other trials with ELEVIDYS. Based on these outcomes, Hansa and Sarepta will discuss appropriate next steps for the program.

“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. 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. We also look forward to reporting data from another ongoing gene therapy collaboration later this year, to continue to collect evidence of the potential benefits of imlifidase in gene therapy,” says Renée Aguiar-Lucander, CEO, Hansa Biopharma.