Third Death In Audentes’ XLMTM Gene Therapy Trial
But Companies Remain 'Committed'
Astellas subsidiary says it “remains committed” to on-hold program in high-need disease despite fatal events.
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An expert pointed out that XLMTM patients are already at high risk, but if linked to therapy toxicity, the death could doom the ASPIRO trial.
Recent adverse events are ‘speed bumps’ that need to be worked around, biologics center head Peter Marks says; Morgan Stanley’s Peter Hwang asserts high-profile safety issues have added to unpredictability of gene therapy development, dampening investor enthusiasm for the field.
Slated to begin a Phase III later this year of ADVM-022 in wet AMD, Adverum had to scuttle a Phase II study of the gene therapy in DME after a patient suffered ocular hypotension, panuveitis and vision loss in the treated eye.