Toronto, August 18, 2016 – Toronto-based ScarX Therapeutics (ScarX) has received approval from Health Canada to begin a Phase I clinical trial of its SCX-001 nefopam cream, a first-of-its-kind topical treatment developed to significantly reduce surgical scarring.
Applied immediately after surgical wound closure, SCX-001 reduces the amount of scar tissue that develops during the body’s natural healing process. The 24-subject Phase I clinical trial will be conducted at the University of Alberta, and led by Principal Investigator Dr. Edward (Ted) Tredget. Dr. Tredget, a world-leading authority on burn injury and scarring, is Director of the Firefighters’ Burn Treatment Unit and Wound Healing Research Laboratory at the University of Alberta’s Faculty of Medicine & Dentistry, and President of the American Burn Association. Study enrolment is expected to begin in October, 2016.
“There is unquestionably a pressing need for new approaches to scarring and fibrosis; ScarX is the first treatment we’ve seen that has the potential to address this issue in a meaningful way,” says Dr. Tredget. “In addition, the model developed to test this treatment can be used to evaluate other new therapies for patients with scarring problems in the skin and potentially other tissues. In this regard, ScarX is leading crucial innovation that we anticipate will have broad and lasting impact on how we treat scarring.”
The company received an official No Objection Letter from Health Canada in July, giving them the green light to proceed with a Phase I clinical trial.
“Health Canada’s approval to begin clinical trials represents a significant milestone for ScarX and a promising advance for surgical patients,” says Stephen Whitehead, ScarX President & CEO. “Surgical scarring affects more than 100 million people in the developed world each year; most of these patients are unhappy with their scars. Despite this significant unmet need, no clinically-proven prescription anti-scarring treatment is available today. Our innovation will bring this critical therapeutic to market.”
ScarX Therapeutics is built on the research of its Chief Scientific Officer, Dr. Benjamin Alman, Professor in University of Toronto’s Department of Surgery and Adjunct Scientist at The Hospital for Sick Children (SickKids). Dr. Alman, who concurrently serves as Chair of Orthopaedic Surgery at Duke University, discovered that nefopam (the active ingredient in SCX-001), a well-characterized small molecule, modulates a protein called beta-catenin that is associated with excessive or hypertrophic scarring in humans.
The molecule, originally developed more than 30 years ago as a prescription oral and IV analgesic, had never been applied to dermal scarring until Dr. Alman uncovered this new application. He invented the technology while at SickKids; ScarX Therapeutics was spun off as an Ontario-based company by MaRS Innovation in partnership with SickKids.
In addition to the obvious cosmetic concerns, Dr. Alman notes that scarring can cause considerable disability, especially when it occurs near a joint. “We have significant evidence to indicate that we have a first-in-class therapeutic approach to the problem of dermal scarring,” Dr. Alman says. “While many factors play a role in excessive scarring, our work in the lab found that beta-catenin activation is a common mechanism for hypertrophic scars and we are pleased to see this research discovery be translated from bench to bedside.”
For the purposes of the study, two dozen healthy participants will be recruited to evaluate the safety of the cream. Participants will be treated for a period of three weeks, and followed for a further three months, with results expected to be available in Q3/2017.
In January 2016, ScarX closed a $2 million financing round supported by Accel-Rx Health Sciences Accelerator, BDC Capital, MaRS Innovation, and other investors, adding to previous investments from Ontario Centres of Excellence (OCE).
ScarX Therapeutics is a Canadian biotechnology company, founded in partnership with The Hospital for Sick Children and MaRS Innovation, that discovers and develops innovative treatments for dermal scarring (fibrosis). The company’s lead candidate will be the first topical prescription cream to treat and prevent post-surgical scarring, with the eventual goal of creating better functional and cosmetic outcomes for patients. In 2015, BioCentury featured ScarX Therapeutics as an emerging company to watch. To learn more, visit www.scarxtherapeutics.com.