Adverum Biotechnologies, Inc. (ADVM) Monday announced positive topline 52-week data from the LUNA Phase 2 study of the company's gene therapy product candidate Ixo-vec for the treatment of wet AMD. The company also reported encouraging 4-year long-term follow-up data from OPTIC study. The company's shares were up more than 13 percent in pre-market.
In the ongoing LUNA study, wet AMD patients were randomized to receive either Ixo-vec dose of 6E10 or 2E11 vg/eye. LUNA is designed to inform the selection of both the Ixo-vec dose and prophylactic regimen for Phase 3 registrational trials. OPTIC is an ongoing long-term study, in which patients received 2E11 or 6E11 doses of Ixo-vec.
"Both OPTIC 2E11 results and LUNA efficacy data at 52 weeks show maintenance of visual and anatomic endpoints with over 80% reduction in injection burden and greater than 50% injection freedom," said Laurent Fischer, president and chief executive officer of Adverum Biotechnologies.
The company plans to initiate a Phase 3 study of 6E10 dose of Ixo-vec in the first half of 2025.
Adverum stock had closed at $6.86, down 5.38 percent on Friday. It has traded in the range of $6.38 - $29.70 in the last 1 year.
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