Adverum Halts Phase II Gene Therapy Trial After Patient’s Vision Loss
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.
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Adverum said it would cease developing ADVM-022 for DME and focus on wet AMD, but the adverse events that prompted the shift could invite further scrutiny in an already competitive market.
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.
Biogen is Capsigen’s first partner, while Dyno Therapeutics has also entered into deals potentially worth billions with large drug and biotech firms.