October 25, 2018 | Scarless Laboratories Receives FDA Clearance to Initiate Phase I/IIa Trial of SLI-F06 Peptide for Scar Reduction
LOS ANGELES – (BUSINESS WIRE) – Magnify, the California NanoSystems Institute (CNSI) incubator at UCLA, is pleased to announce that Scarless Laboratories, Inc. (SLI) has received clearance from the U.S. Food and Drug Administration (FDA) to enter a Phase I/IIa Clinical Study of its novel therapeutic peptide, SLI-F06, to promote wound healing and improve scar appearance.
SLI was founded by UCLA Professors Chia Soo, M.D., FACS, Kang Ting, D.M.D., DMedSc, and Zhong Zheng, Ph.D., with CEO Carol Danielson, Ph.D. SLI, housed at Magnify, is focused on revolutionizing tissue repair and disrupting the billion dollar scar treatment and chronic wound healing industries.
SLI-F06 is a novel synthesized and modified polypeptide that mimics a key biological factor required for fetal scarless skin repair. While adult skin wounds heal by scar formation, fetal skin wounds heal by regeneration with the restoration of normal skin. SLI-F06 has a unique mechanism of action that biologically activates the wound cells to heal with less scarring by promoting cell migration – cells move to the wound faster – and cell differentiation and function –cells mature faster and work better in the wound. SLI-F06 modulates the early wound environment to promote accelerated wound healing, reduce scarring, and increase wound tensile strength.
The multicenter, double-blind study will be divided into two parts:
Part A is a Phase I safety/proof of concept study of wound healing and scar appearance in multiple small surgical wounds made in the section of abdominal skin scheduled to be excised during routine abdominoplasty (“pre-abdominoplasty” patients). At predefined times, “pre-abdominoplasty” patients in Part A will undergo abdominoplasty to start Part B.
Part B is a Phase IIa safety and efficacy study of postoperative scar appearance in patients undergoing abdominoplasty. Phase IIa is intended to provide the safety and efficacy data required to move into a larger Phase IIb study with an expanded patient population.
The SLI-F06 peptide is based on over twenty years of research at UCLA. Preclinical testing at UCLA using pig models demonstrated significant efficacy in improving scar appearance and strength and reducing scar size. In FDA-required preclinical safety studies, SLI-F06 was found to be safe in the rat and pig at maximum feasible doses.
Cutaneous fibrosis, or scarring, affects millions of patients per year in the United States. The global scar treatment market generated $19.2 billion revenue in 2017. Most scars are post-surgical, resulting from elective surgeries and surgeries for traumatic injuries. There are no FDA-approved therapeutic agents that biologically activate cells to promote tissue repair rather than excessive scarring. Current marketed products for scar treatment are mostly applied to pre-existing scars and are not intended to minimize a scar before it forms. While there are treatment options for patients who wish to minimize scar formation during post-surgical wound healing, there is a significant need for safer therapies to prevent or minimize scar formation without compromising wound strength.
Upon the successful completion of this study and with appropriate industry partnerships in place, SLI will expand the product development pipeline to include additional applications such as chronic wound healing and combination product-medical devices and topical peptides.
“The ability to biologically activate wound cells to affect faster and better tissue repair with less scarring can be tremendously impactful for patients suffering from disfiguring hypertrophic or keloid scars such as burn patients,” said Soo, who is also the Vice Chair for Research for UCLA Plastic and Reconstructive Surgery. “Faster and better healing can also benefit chronic wound patients, especially diabetic foot ulcer patients, to reduce the risk of limb amputation from non-healing wounds.”
The company has been funded by private investors and the National Institutes of Health. A key partner is the National Institute of Dental and Craniofacial Research (NIDCR) Center for Dental, Oral, and Craniofacial Tissue and Organ Regeneration (C-DOCTOR).
“We’re very excited about SLI’s technical progress and the recent FDA clearance for clinical trials,” said Ben Wu, D.D.S., Ph.D., who is the UCLA Director of the C-DOCTOR Consortium. “The development of versatile applications to maximize clinical impact on various wound healing clinical problems is exactly what C-DOCTOR is looking to achieve.”
Magnify, the California NanoSystems Institute (CNSI) incubator, accelerates the growth and success of transformative technology startups in the greater Los Angeles area by providing high-quality, affordable facilities, services, and expertise in a vibrant community of innovation. Centrally located at UCLA, Magnify offers entrepreneurs unique access to a collection of advanced instrumentation, business development and funding advice, as well as entrepreneurial networking and mentorship opportunities to vastly increase a startup’s likelihood for success.
Magnify at CNSI