With Adverum Biotechnologies Inc.’s preliminary safety and efficacy data made public from the ongoing Luna phase II trial testing gene therapy ixoberogene soroparvovec (ixo-vec) in wet age-related macular degeneration (AMD), Wall Street promptly began stacking the results against those of competitors. CEO Laurent Fischer pointed out that ixo-vec boasts the “highest rate of injection-free patients of any study of any program at any dose.”
Adverum Biotechnologies Inc. CEO Laurent Fischer said the firm chose the more prudent route in scrapping development of gene therapy ADVM-022 (AAV.7m8-aflibercept) for diabetic macular edema (DME) as a result of dose-limiting toxicity in the phase II Infinity trial.
Earlier this month, an update on phase I/IIa data rolled out from Rockville, Md.-based Regenxbio Inc. with RGX-314 for age-related wet macular degeneration (AMD). The company has a pivotal program in subretinal delivery of the compound set to start by the end of this year, and questions about routes of administration – always an issue in AMD – continue to simmer.
Following FDA approval of Novartis AG's VEGF-A inhibitor, Beovu, in wet age-related macular degeneration earlier this month, speculation immediately started on how much market share that new therapeutic will capture at the expense of Regeneron Pharmaceutical Inc.'s Eylea.
Something of a duel may be shaping up between Menlo Park, Calif.-based Adverum Biotechnologies Inc. with ADVM-022, the phase I gene therapy candidate for wet age-related macular degeneration (AMD) and Regenxbio Inc., of Rockville, Md., with a similar candidate.