If you haven’t heard of Eirion Therapeutics yet, you will. That’s a promise. Headquartered in Woburn, MA, the aesthetic dermatology company boasts a disruptive pipeline focusing on treatments for wrinkles, primary axillary hyperhidrosis, androgenic alopecia, and hair graying and just scored some major financing. Jon Edelson, MD, Eirion’s Chairman, CEO, and President, talked to Modern Aesthetics® magazine about what we can expect in the coming weeks, months and years.


“Eirion Therapeutics, Inc. recently closed a $40 million Series A investment and licensing deal with Shanghai Haohai Biological Technology Ltd. The deal will result in a $32 million Series A Preferred Stock investment into Eirion along with exclusive licenses that will be for all of Eirion’s products for the territory of China in exchange for an upfront payment of $8 million. The deal is struc- tured in segments over the next 18 months. Haohai’s dermal filler products include Hyalumatrix, Matrifill, and Janlane. The companies have signed two product licenses that have the potential in aggregate to provide Eirion approximately $43 million in development fees,

$444 million in sales milestones, with significant product royalty rates. One license is for Eirion’s neuromodulator- based product candidates, ET-01 (topical) and AI-09 (injectable) for aesthetic indications; and a second license is for Eirion’s small molecule product candidates, ET-02 (topical) and ET-03 (oral), which are intended for the treatment of hair loss and hair greying. Under the terms of the licenses, the products will be manufactured in the US by Eirion and developed and commercialized by Haohai in China.”


“The new funding is very exciting and important. It allows us to move our entire pipeline forward starting with our topical neuromodulator (ET-01), which is in Phase 2 trials for smoothing lateral canthal lines. This funding will get us to Phase 2b. Two aspects of this technology are unique. Our topical product is formulated with a patented proprietary nanoemulsion delivery system that allows the product to enter the skin. The skin is preconditioned to create temporary micropores, which further accelerates the delivery. We are creating portals in the skin mechanically that close up after the procedure. These two things together make for a highly different approach. The procedure itself takes five to 10 minutes with no downtime. This will be a paradigm change and has the potential to greatly expand the neuromodulator market. The same technology is being investigated for hyperhidrosis. There is still a significant unmet need here. The current hyperhidrosis treatments all present some challenges. For example, Botox injections require up to 15 needle sticks per underarm. This is painful and time consuming. Our topical product, ET-01, is specifically for underarm hyperhidrosis.”


“Our treatments, ET-02 and ET-03, target a defect we have identified in stem cells in hair follicles that controls hair growth and hair color. If we reverse this defect or prevent it from emerging, we can affect hair loss and hair graying. Billions of dollars are spent on hair dye each year, most of which goes to covering up grays. There is a tremendous benefit if a pharmaceutical could address this problem. In controlled non-clinical studies of human scalp tissue affected by androgenic alopecia, ET-02 demonstrated approximately twice the hair growth compared to a control treatment over approximately four months. This amounted to approximately three times the hair growth per centimeter seen in minoxidil clinical

trials that were 12 months in duration. Eirion plans to launch its first clinical trial of ET-02 in 2022.”


“All the current neuromodulator injectables have to be reconstituted in a doctor’s office with saline which can be time consuming and inconvenient, compared to off-the-shelf dermal fillers. AI-09, an injectable which is being developed for the treatment of glabellar lines, does not need to be reconstituted. It also has other benefits. There is no albumin, which carries a risk of disease transmission, and it is stable for weeks or months. In contrast, current formulations have a limited shelf life once reconstituted. Eirion plans to file an IND for AI-09 later this year.”


“Right now we are five-person company, but the new funding will allow us to expand. We have a very capital-efficient model where we outsource most tasks. We have partners who manufacture and test products, and we work with aesthetic practices who do the clinical trials. We invent and direct the processes. We will start to have our research presented on podiums at clinical conferences in the next few years. We already have a distinguished group of advisers including Ken Beer, MD, a dermatologist in West Palm Beach and Jupiter, FL, and Cary, NC-based dermatologist Tim Flynn, MD. For our androgenic alopecia candidate, we are working with Jerry Shapiro, MD, a dermatologist in New York City, and Ken Washenik, MD, PhD, President and CMO of Bosley Medical Group in Beverly Hills. In the coming years, I’d like to see all the products on the market improving the quality of life of those who use them.”