• Avita Medical successfully achieved two co-primary endpoints
  • Noxopharm received $5.011 million in R&D rebate

Avita makes crucial progress in pivotal trial

Avita Medical (ASX:AVH) announced that it has achieved the co-primary endpoints in an updated analysis of its pivotal trial of RECELL System for soft tissue repair.

The study design had included two co-primary endpoints based on pairwise comparisons where each subject received both RECELL treatment and standard of care treatment (Control).

One endpoint had a hypothesis of superiority for donor skin sparing, and the other co-primary endpoint had a hypothesis of non-inferiority for healing.

Avita says both co-primary endpoints have been met.

Latest results showed that RECELL achieved statistically significant donor sparing over Control (p<0.001). RECELL also achieved statistical non-inferiority for healing versus Control (p<0.025).

Previously, the company announced that the donor sparing endpoint had achieved superiority, and that the healing endpoint had just missed non-inferiority.

Subsequently, further re-verification resulted in corrections to the healing data, ultimately leading to a conclusion of non-inferiority for healing.

“These results reinforce the potential for RECELL to become a new standard of care for soft tissue repair,” said Jim Corbett, Avita’s CEO.

“We look forward to sharing the soft tissue repair outcomes with the FDA via our PMA submission expected in December 2022.”

The Avita RECELL System was approved by the US FDA in September 2018.

The RECELL System is used to treat acute partial-thickness thermal burn wounds in adult patients, or in combination with meshed autografting for acute full-thickness thermal burn wounds in children and adults.

Noxopharm receives $5m in rebate

Noxopharm (ASX:NOX) has received a $5.011 million rebate under the Australian Government’s Research and Development Tax Incentive scheme for expenditure during FY22.

The rebate is set to strengthen Noxopharm’s cash position as it looks to advance its drug development pipeline.

Noxopharm has three active drug development programs: its clinical drug candidate Veyonda, plus two technology platforms – Chroma (oncology) and Sofra (inflammation and autoimmunity).

“Specifically, it will support our ongoing clinical trials for Veyonda, as well as further our early-stage R&D assets via the Chroma and Sofra programs,” said Noxopharm CEO Dr Gisela Mautner.


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