Adverum's Data at ASGCT Further Supports Phase 2 Development Plans For Wet-AMD Gene Therapy

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  • Adverum Biotechnologies Inc ADVM has shared new data from the ADVM-022 development program in wet age-related macular degeneration (wet AMD). 
  • The data were presented at the American Society of Gene and Cell Therapy (ASGCT) 2022 Annual Meeting.
  • It exhibited results of the non-human primate (NHP) studies that provide support for the new 6 X 10^10 vg/eye (6E10) dose that Adverum intends to include in its next clinical trial.
  • Related: Adverum Bio Posts Additional Efficacy, Safety Data From ADVM-022 Gene Therapy In Wet AMD.
  • The human equivalent dose of 6E10 (3 X 10^10 vg/eye dose in NHP) demonstrated potential therapeutic levels in both aqueous humor and vitreous humor.
  • Administration of the human equivalent dose of 6E10 (3 X 10^10 vg/eye dose in NHP) was well tolerated. No adverse clinical signs were observed during the three-month study.
  • "These new data suggest the 6x10^10 vg/eye dose may provide therapeutic levels of aflibercept in the clinic and informs our dosing regimen in our upcoming Phase 2 trial," said Laurent Fischer, M.D., president and CEO at Adverum. 
  • The company plans to initiate the Phase 2 study in wet AMD in Q3 2022, evaluating ADVM-022 at the 2x10^11 vg/eye dose and the new, lower 6x10^10 vg/eye dose with new enhanced prophylactic steroid regimens.
  • Price Action: ADVM shares closed 5.03% higher at $0.87 during after-hours trading on Tuesday.
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