RepliCel Life Sciences (OTCQB:REPCF; TSXV:RP; FRA:P6P2) reported statistically and clinically significant positive data from an interim analysis of its Phase I study evaluating RCS-01 for the treatment of aging and sun-damaged skin.
The primary objective of the trial was to establish a complete safety profile for intradermal injections of RCS-01, RepliCel's type 1 collagen-expressing, hair follicle-derived fibroblasts at six months post-injection.
Participants in the Germany-based study did not report any serious adverse events at the interim point of the trial. Researchers also gathered compelling positive proof-of-concept data indicating the product's potential for skin rejuvenation.
The study was neither powered for, nor was expected to show statistically significant results of efficacy. However, the nearly two-fold increase in gene expression of collagen-related biomarkers in the skin, after a single injection of RCS-01, was so profound with a single RCS-01 injection, that the results are considered statistically significant.
"Replication of these results in a larger trial would confirm our view of the product's potential as a more natural alternative to Botulinum toxins and fillers that only temporarily prevent and reverse the signs of aging," Prof. Dr. med Jean Krutmann, scientific manager of the IUF Leibniz Research Institute for Environmental Medicine, where the study was conducted, said in a statement.
Dr. Rolf Hoffmann, RepliCel's CMO, said the study not only showed an excellent safety profile, but also provides compelling proof-of-concept that RepliCel's RCS-01 cells are, by nature, very good collagen producers in the skin. “This is the first example of a treatment potentially capable of rejuvenating UV-damaged skin."
President and CEO, Lee Buckler, said this is the most compelling data RepliCel has announced to date.
"Longer term, this data is very complementary to our focus on commercializing a next-generation dermal injector and its targeted application not only with RCS-01, but also with other aesthetic products on the market today,” he added.
Mr. Buckler said RepliCel plans to discuss these findings and the potential of its products with a number of aesthetic-focused institutional investors and major multinational licensing partners who have already expressed interest in the company’s programs.