Just to quote it all at once, before we start to over speculate what Replicel want to do or not.
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. There is a possibility the data from this study may be enough for Shiseido to decide to launch the product in Japan. All such commercial decisions for this product related to Asia (e.g., timing of product launch, pricing, etc) are for Shiseido to decide.
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
Will the RCH-01 treatment create greater hair density increases when it is commercially approved than we saw in the phase 1 trial?
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.
Will RCH-01 treatment work for people with the most advanced stages of hair loss?
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.
Will RCH-01 treatment work for hair loss caused by conditions other than androgenetic alopecia?
We won’t know the answer to this until we do research and/or clinical testing on conditions other than androgenetic alopecia.
When will the RCH-01 treatment for pattern baldness be available on the market?
In short, we are not yet in a position to adequately predict this. RepliCel recently completed phase 1 human clinical trials of all its products currently in development, including RCH-01. In most countries, it takes completing at least three phases of clinical trials to obtain approval to market a product.
Japan has recently created rules by which certain cell therapies may be commercially launched much faster than is the case in most countries. This has fueled speculation that RCH-01 may be put on the market after the current trial being conducted in Japan is completed sometime in 2018. While this is a possibility there is not guarantee this will happen for a host of reasons. Stay tuned!
