- The US Food and Drug Administration (FDA) approves change to Avita Medical’s (AVH) trial for the treatment of skin disease, vitiligo
- Instead of a three-arm study of 84 subjects, the study has been simplified to a new single-arm design to evaluate 23 subjects at 15 clinical sites
- AVH says the decision comes from other data which suggests no meaningful clinical performance differences among the three cell suspensions
- Its hoped the new design will see the program progressing in a timely and cost-effective manner, with AVH aiming to enter the US market by 2023
- Shares have been trading 1.27 per cent lower at $4.66 at 1:48pm AEST
The US Food and Drug Administration (FDA) has approved a change to Avita Medical’s (AVH) trial for the treatment of skin disease, vitiligo.
The company’s pivotal clinical trial is assessing the safety and effectiveness of its RECELL System for the re-pigmentation of stable vitiligo lesions.
Vitiligo is a disease resulting in loss of colour, or pigmentation, in patches of skin with no current cure or universally accepted method for limiting its spread.
While AVH’s RECELL system is currently used in the treatment of burns, the company is trialling the “Spray-On Skin Cells” technique in treatment of depigmented vitiligo lesions in patients whose vitiligo is stable, with no new lesions or expansion of lesions for at least one year.
Effectiveness is based on a comparison between RECELL and standard of care controls in re-pigmentation.
Long-term durability data, assessing sustained repigmentation over 52 weeks will be collected.
Initially, the company’s trial consisted of a three-arm study of 84 subjects, with the first patient enrolled in September 2020.
However it has decided to pursue a new single-arm design to evaluate 23 subjects at 15 clinical sites.
Avita said the amendment came from data that indicated the “improbability” of “meaningful” clinical performance differences among the three cell suspensions.
Moreover CEO Mike Perry said the design change reflected confidence both in the safety profile of RECELL and in the anticipated high incidence of re-pigmentation.
It’s hoped the simplified study design and reduced number of study subjects will aid the program to progress in a timely and cost-effective manner.
The company said the program was on-track and it believes it could be in a position to enter the US market, following successful completion of the clinical trial as early as the second half of calendar year 2023.
SShares have been trading 1.27 per cent lower at $4.66 at 1:48pm AEST.