FDA Approves AVITA Medical Vitiligo Trial With Fewer Participants - AVITA Medical (NASDAQ:RCEL)

The FDA has approved AVITA Medical Inc's 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.