Benzinga | Aug 16, 2021 10:36AM EDT

FDA Approves AVITA Medical Vitiligo Trial With Fewer Participants

* The FDA has approved AVITA Medical Inc's (NASDAQ:RCEL) request to amend its pivotal trial evaluating RECELL System for the repigmentation of stable vitiligo lesions to a streamlined single-arm trial design.

* The Company will pursue a single cell suspension formulation (1:20 expansion ratio) against the three cell suspensions in the initial trial design.

* The new single-arm design will evaluate 23 subjects at 15 clinical sites versus a previously approved 3-arm study of 84 subjects.

* The primary effectiveness evaluation is based on comparing the incidence of successful repigmentation with RECELL versus that of a standard of care control.

* Long-term durability data (assessing sustained repigmentation over 52 weeks) will be collected.

* As with the previous design, an interim analysis will be conducted on 24-week data for approximately half of the subjects to evaluate the sufficiency of the sample size, with a possible increase to sample size as needed (up to 46 subjects).

* Vitiligo is a disease resulting in loss of color or pigmentation in patches of skin.

* Price Action: RCEL shares are down 0.72% at $17.26 during the market session on the last check Monday.

* Related content: Benzinga's Full FDA Calendar.