Toronto, June 27, 2017 – ScarX Therapeutics Corp. (“ScarX”) today announced it has completed enrollment for its initial human clinical trial of SCX-001, a first-of-its-kind topical treatment to significantly reduce surgical scarring. The Phase I trial will establish the safety profile of SCX-001 and integrates secondary endpoints to assess efficacy in reducing dermal scarring. ScarX expects study results to become available in late 2017.
SCX-001 is applied topically after surgical wound closure to reduce the amount of scar tissue that develops during the healing process. More than 100 million people in the developed world are affected by surgical scarring every year. In the United States, there are an estimated 7.4 million cosmetic and reconstructive plastic surgery procedures annually, leading management to estimate a U.S. target market of $2.5 billion.
“ScarX Therapeutics is working to transform scar treatment and prevention,” said Stephen Whitehead, President and CEO. “Virtually everyone identifies with the need to minimize scarring and current treatment options are exceptionally limited. SCX-001 is a novel agent that promises to help physicians heal wounds and lead to better outcomes for patients.”
The Phase I clinical trial is being conducted at the University of Alberta, led by Principal Investigator Dr. Edward (Ted) Tredget, who is a prominent expert in the treatment of burn injuries and hypertrophic scarring. Dr. Tredget is Director of the Firefighters’ Burn Treatment Unit and Wound Healing Research Laboratory at the University of Alberta, and a past President of the American Burn Association.
For the Phase I study, healthy volunteers are given identical surgically-induced wounds on each hip. They are then treated on one side with topical SCX-001 and on the other with placebo, twice daily for three weeks, and monitored for a three-month follow-up period. Two doses of SCX-001 are being tested (1% and 3% formulations) in this within-subject-control study design.
“This significant clinical milestone for ScarX leverages thirty years of research from our scientific founder, Dr. Ben Alman, while at the Toronto Hospital for Sick Children,” says Parimal Nathwani, Executive Chairman of ScarX Therapeutics and Vice President at MaRS Innovation, a founding investor. “Beyond the palpable excitement from the clinical community and future patients, we are advancing discussions with potential partners and investors to further advance product development.”