RCH-01: Androgenetic Alopecia
In 2017, RepliCel completed a phase 1 human clinical trial of RCH-01 in patients with androgenetic alopecia. The study proved the product’s safety and provided very promising indications of the product’s efficacy in terms of minimizing hair loss and increasing hair density in a subset of patients. We are very excited about this product’s potential but have several steps to go yet before we can bring it to the market.
A human clinical study of RCH-01 was recently completed at Tokyo Medical University Hospital and Toho University Ohasi Medical Center in Japan. The study was funded by RepliCel’s partner, Shiseido Company, which also manufactured the product for the study at its facility in Kyoto, Japan. The study was a randomized, double-blinded, placebo-controlled, dose-finding study of a one-time injection of RCH-01 (different doses vs placebo) in male and female patients with different stages of advanced hair loss dues to androgenic alopecia.
The results of this study confirmed the safety conclusions and efficacy observations from the phase 1 study but this time with statistical significance and clinically meaningful results with the low-dose tested. See here for more commentary on the data from this study.
Shiseido is now actively recruiting patients in another clinical study of the product in Japan this time involving a series of injections several weeks. RepliCel is also planning a phase 2 clinical study of RCH-01 testing even lower doses of RCH-01 than already tested, in a series of injections using RepliCel's proprietary RCI-01 dermal injector.
RepliCel is currently working with investigators at the University of British Columbia on a research study that is anticipated to provide improvements to the technology related to manufacturing, product profiles, and clinical outcomes.
We will continue to keep our stakeholders informed as we evaluate the right time to move into our own phase 2 clinical trial of RCH-02 (likely in Europe). If you are interested in signing up to stay informed or to register your interest in participating in a future trial (should one be located in your area), please use the sign-up form here.
FAQs About RCH-01
We certainly expect to see better outcomes in future trials because the product is continuously being improved, finding the best dose should deliver better results, and we expect to see greater hair density increases when we are permitted to test multiple rounds of injections.
We won’t know the answer to this until we do clinical testing on more advanced stages of hair loss than we did in our phase 1 trial.
We won’t know the answer to this until we do research and/or clinical testing on conditions other than androgenetic alopecia.
In short, we are not yet in a position to adequately predict this. RepliCel has completed phase 1 human clinical trials of all its products currently in development, including RCH-01. In Japan, Shiseido has funded a second study of the product to identify the optimal dose to be injected. Shiseido is now funding a third clinical study evaluating multiple injections of the optimal dose in a series of injection treatments over several weeks. In most countries, it takes completing at least three phases of clinical trials to obtain approval to market a product.Positive data from this study could lead to the launch of the product in Japan as early as 2023 but there is no guarantee this will happen for a host of reasons. Stay tuned!