Adverum Outlines Development Plan For ADVM-022 Gene Therapy In Wet AMD

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Adverum Biotechnologies Inc ADVM plans to conduct a Phase 2 trial of ADVM-022 in wet AMD at 2 X 10^11 vg/eye dose and a new lower 6 X 10^10 vg/eye dose, with three new enhanced steroid prophylaxis regimens in wet age-related macular degeneration (wet AMD). 

  • The enhanced steroid prophylaxis regimens include topical, intravitreal (IVT), and a combination of systemic and local steroids. 
  • The trial is expected to enroll approximately 72 patients and evaluate similar endpoints to the Phase 1 OPTIC trial in wet AMD. 
  • Related: Adverum's Single-Dose Wet AMD Gene Therapy Shows Robust Two Year Durability, Safety.
  • Adverum plans to file an investigational new drug (IND) amendment in 1H of 2022.
  • The Company has begun preparing for the Phase 2 trial of ADVM-022 in wet AMD to initiate dosing in Q3 of 2022 and complete enrollment by the end of 2022.
  • At the end of Q3, the Company held cash, cash equivalents, and short-term investments of $332.7 million. Adverum expects this quarter-end cash position to fund operations into 2024.
  • Price Action: ADVM shares are up 0.27% at $1.87 during the market session on the last check Tuesday.
Posted In: BiotechNewsPenny StocksHealth CareGeneralAge-Related Macular DegenerationBriefsgene therapyPhase 2 Trial
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