Positive burns trial results and a new CEO at Avita Medical

The board of regenerative medicine company Avita Medical has appointed Dr Michael Perry as its new CEO, effective immediately.

Currently based in the US, Dr Perry has been an Avita non-executive director since February 2013. His former executive role was senior vice president and chief scientific officer of global business development and licensing for Novartis AG. He also served as chief scientific officer of Novartis’ Cell and Gene Therapy Unit from 2014–16.

The board determined that Avita’s recent achievement of US-focused milestones will largely drive company value, including a US$62 million contract with US defence preparedness group BARDA for burns applications using Avita’s ReCell autologous cell harvesting device. As such, a decision was made to retain a US-based chief executive to optimise shareholder value. Former CEO Adam Kelliher, based in London, elected not to relocate to the US and has thus resigned from his position, but will remain a consultant to the board of directors.

“We are most grateful to Mr Kelliher for his significant contributions to Avita during his tenure,” said Avita Chairman Lou Panaccio. “He oversaw a diversity of critical company achievements, most notably progress of our clinical programs, strategic capital raises and continued progress on our BARDA contract. We are also appreciative of the keen focus and energy he brings to his work — qualities we are sure he will apply in his future endeavours.

“Mike’s expertise across the value chain in cell therapy along with his experience in business development, regulatory affairs and general management will be crucial to Avita’s future success. These fundamental attributes, complemented by his US presence, will maximise Avita’s prospects as the company progresses through PMA submission, FDA review and preparation for large-scale product commercialisation.”

Avita recently completed a US pivotal burns trial which compares ReCell in combination with meshed autograft against conventional skin grafts, results of which were released on 18 May. The company achieved both co-primary endpoints for the trial, which will soon be submitted to the FDA as part of an application to support premarket approval (PMA) for the treatment of severe burns.

The 30-patient trial was conducted at seven US burn centres between 2015 and early 2017. Co-primary endpoints were designed to demonstrate the effectiveness of ReCell when combined with widely meshed (expanded) skin grafting in the closure of deep-partial and full-thickness burn injuries. Treatment was randomly allocated to two separate parts of each patient’s burn wound such that a controlled comparison of outcomes could be made for conventional skin grafting versus the combination of ReCell with a more expanded skin graft.

The first co-primary effectiveness endpoint gauged superiority of donor skin expansion, to resolve whether using ReCell could lead to less donor skin being needed. Donor skin expansion with ReCell resulted in use of an average of just over 30% less donor skin than the control — an important result for patients dealing with burn injuries, as the harvesting of donor skin adds discomfort and increases the effective size of their injury.

The second co-primary effectiveness endpoint explored the incidence of healing within eight weeks, which was similar in wounds that received ReCell compared to those that received control treatment. Healing with ReCell was found to be statistically non-inferior relative to conventional treatment.

Three secondary endpoints evaluated patient preference of scar outcomes, along with patient- and blinded-observer overall opinion ratings using a standardised scar assessment scale. No statistical difference was observed between ReCell and control on these measures. The company said it was encouraged by the equivalent secondary endpoint data because more expanded meshed skin grafts are expected to result in a worse long-term scar outcome, but this was not the case with the adjunctive use of ReCell with these autografts.

Avita is now focused on fulfilling requirements for remaining non-clinical data needed for the PMA submission, which is on track for mid-2017. Based on expected timelines, approval could occur by Q2 2018, the company said.