RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB), on April 4, announced that interim analysis of its Phase 1 study evaluating RCS-01 for sun-damaged and aging skin has produced "statistically and clinically significant positive data." According to the company, 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 ["NBDS cells"]) 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."
Although the study was not designed to test efficacy, the company reported that 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."
"This is the most compelling data we have announced to date," stated RepliCel CEO and President, R. Lee Buckler. "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. We look forward to discussing these findings and the potential of our products with a number of aesthetic-focused institutional investors and major multinational licensing partners who have already expressed interest in our programs."
Douglas Loe, an analyst with Echelon Wealth Partners, wrote on April 4 that the RCS-01 Phase 1 data "reveals clear biochemical signals that justify further Phase 2 dermatology testing." Loe stated that the skin trial "absolutely met its primary endpoint of demonstrating safety in patients, with no serious adverse events reported at the time of the trial. . . The lack of an observable side effect profile at least reassures us that RCS-01 development can continue Phase II testing unencumbered by any acute safety concerns and we do not expect regulators to see RCS-01 safety profile as an impediment to future studies."
The RCS-01 trial interim analysis follows RepliCel's March 28 announcement of "compelling safety and clinical data from its phase 1/2 tendon repair study investigating the use of RepliCel's type 1 collagen-expressing, hair follicle-derived fibroblasts (RCT-01) as a treatment for Achilles tendinosis."
On March 14, RepliCel reported the "successful completion of its first-in-human clinical study of the Company's autologous cell therapy for the treatment of androgenetic alopecia (pattern baldness). . .the five-year trial data set has confirmed the complete safety profile of a high-dose of dermal sheath cup cells (DSCC) for patients with pattern baldness due to androgenetic alopecia."
Douglas Loe concluded that "our expectations for RepliCel's recently updated suite of Phase I data in androgenetic alopecia, in Achilles tendinosis, and now in skin rejuvenation were all under best-case scenario going to provide insight into clinical path forward more than be definitive on clinical approvability as such, but on that basis, we consider Phase I performance for all NBDS and dermal sheath cup (DSC) cell therapies just concluded to be highly supportive of ongoing Phase II testing in relevant markets, including in skin rejuvenation."
In an April 3 report, Zacks Small-Cap Research stated that RepliCel is "targeting three potentially multi-billion dollar markets: regenerative hair growth, skin aging, and chronic tendinosis." It concludes that "with a market cap of only $17 million and positive data for its lead products, we believe that now is an excellent opportunity for investors to get to know RepliCel better as the opportunity for outsized returns is a distinct possibility."
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