Avita Medical receives FDA green light for US trial of potential vitiligo treatment

Melbourne-based medtech company Avita Medical (ASX: AVH) has received US Food and Drug Administration (FDA) approval to amend its clinical trial for the treatment of vitiligo patients, giving hope to the millions that suffer from the rare skin condition globally.

The study will assess the safety and effectiveness of Avita's RECELL System in the treatment of those with vitiligo - an autoimmune disease that results in the depigmentation of skin.

Vitiligo affects around 6.5 million people in the United States and around 70 million globally, and there is currently no cure for the autoimmune disease nor a method for limiting the spread of it.

Those impacted by vitiligo report discolouration of the skin and hair in patches as the disease destroys the functionality of pigment-producing cells. Famous examples of those with vitiligo include the late Michael Jackson and supermodel Winnie Harlow.

Avita will study its regenerative skin treatment RECELL for the repigmentation of stable vitiligo lesions. Previously, RECELL has been primarily used on burns victims, but the ASX-listed company is hopeful for a "high incidence of repigmentation".

RECELL, which was developed by Perth surgeon Fiona Woods and used to treat victims of the Bali bombings in 2002, is also approved by the FDA to treat full-thickness thermal burns that cover more than 50 per cent of the total body surface area.

Today's FDA approval is a milestone moment for Avita which hopes to launch the vitiligo treatment in the US market as early as the second half of 2023 if the trials prove successful.

"The simplified study design and reduced number of study subjects reflects confidence both in the exceptional safety profile of RECELL and in the anticipated high incidence of repigmentation with RECELL treatment, as we have seen in 11 peer-reviewed publications and in the treatment of more than 1,000 patients outside of the US," Avita Medical CEO Dr Mike Perry said.

"The design change allows this program to progress in a timely and cost-effective manner toward bringing a novel therapeutic option to an underserved population.

"The program is on tracks, and we continue to believe we could be in a position to enter the US market with the vitiligo indication, following successful completion of the clinical trial, as early as the second half of calendar year 2023."

The trial will include 15 clinical sites to test the RECELL system in treatment of vitiligo patients whose disease is stable - meaning they have not had any new lesions or lesions that have expanded for at least one year.

The primary effectiveness evaluation will be based on a comparison of successful repigmentation compared to that of a standard of care control.