
Swedish biotech Hansa Biopharma (Nasdaq Stockholm: HNSA) on Friday released encouraging top-line results from three patients with Duchenne muscular dystrophy (DMD) treated with Hansa’s imlifidase prior to receiving Sarepta Therapeutics’ (Nasdaq: SRPT) Elevidys (delandistrogene moxeparvovec-rokl) in the SRP-9001-104 trial.
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.
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