Adverum Biotechnologies Provides Update on OPTIC Phase 1 Trial for ADVM-022

Adverum Biotechnologies (NASDAQ:ADVM) has announced that the US Food and Drug Administration (FDA) has removed the clinical hold on the company’s ADVM-022 for the second cohort in its OPTIC Phase 1 trial for wet age-related macular degeneration (wet AMD) and allowing a dose increase to 2 x 10^12 vg/eye.

As quoted in the press release:

This dose would be three times higher than the dose of 6 x 10^11 vg/eye evaluated in the first cohort. However, based on the robust preliminary anatomical response observed to date in the first cohort (n=6), Adverum will begin dosing the second cohort at a lower dose of 2 x 10^11 vg/eye, three times lower than the dose used in the first cohort. The dosing of patients in this second cohort is expected to begin in June 2019. Adverum believes that ADVM-022 at a dose of 6 x 10^11 vg/eye has demonstrated the potential to provide sustained efficacy following a single intravitreal injection.

As previously announced, the independent data monitoring committee (DMC) unanimously voted to proceed with dose escalation per protocol following their review of the safety data from the first cohort. To date, no patient in the first cohort has experienced a serious adverse event (SAE), with the first patient completing the 24-week (6 month) assessment.

While the FDA has lifted the clinical hold on the second cohort, ADVM-022 remains on partial clinical hold for dosing patients in the third cohort, with the highest dose of 6 x 10^12 vg/eye. Adverum currently does not plan to dose at this highest level, based on the robust preliminary anatomical response observed in the first cohort of patients. Adverum will continue to work closely with the FDA to resolve the remaining CMC comments.

Click here to read the full press release.