Here is an update of progress:
Clinical Treatments And Drugs For Hair Loss In 2020
TissUse & J Hewitt – TissUse’s hair regeneration therapy is known as the Smart Hair Transplant or SHT which has been in development since 2011. In a familiar format, the SHT method seeks to take about 30 hair follicles from the back of one’s head and turn them into thousands of hair producing cells via culturing. In early 2019, the Japan-based company, J Hewitt, obtained a license to commercialize the SHT procedure. In September 2019, the CEO of J Hewitt announced his plans to conduct a 5 patient SHT trial by the end of the year. Due to complications in preparing the trial with a contracted cell processing company, the start date is now scheduled for late January 2020. J Hewitt’s CEO has made it clear he is committed to taking SHT to trial and proving whether it works in a timely manner. This initiative is possibly the most exciting development in the hair growth industry currently.
Follica – Follica’s FOL-004 treatment is scheduled to enter a pivotal FDA study in 2020. If successful, this final study would allow FOL-004 to become approved in the US and likely in Europe shortly thereafter. The first result photos from Follica’s wounding + topical combination surfaced on the internet in late 2019 and left audiences intrigued. An early estimation for FOL-004 to reach market approval is Q1 2021.
Samumed – The lengthy phase 3 trial of Samumed’s SM04554 is scheduled to complete in June 2020. The company will receive data from over 600 patients who applied its topical Wnt activator SM04554 on a daily basis for roughly a year’s time. Pending results, this trial could lead to the commercialization of SM04554 in Turkey and potentially the US. If approved, the prescription treatment would not reach patients until 2021 at the earliest.
Follicum – In their last major update, Follicum announced it is aiming to begin a phase 2 trial of its newly formulated topical FOL-005 peptide in January 2020. The trial will last around 3 months, so results from this important phase 2 should be available by summer 2020. This will be the first time the peptide will be trialed topically, so results from this trial are particularly important. Follicum’s FOL-005 will be looking to match or better results from its topical peers Breezula and SM04554.
Dr. Tsuji & Organ Technologies – It is anticipated that Dr. Tsuji’s fabled hair cloning therapy will enter its first clinical trial in 2020. A commercial release for this treatment in 2020 is extremely unlikely even with Japan’s expedited regulatory process. However, if Organ Technologies produces a successful initial trial in 2020, the ‘Tsuji hair cloning treatment’ could theoretically become available to patients in Japan within the next few years.
Stemson Therapeutics – The California-based hair regeneration company is within the scope of starting a human trial in late 2020. After launching their website and announcing an investment by Allergan in June 2019, CEO Geoff Hamilton told the media the company expected to begin trials in “about a year and a half.”
HairClone – HairClone continues to strive towards offering its expanded dermal papilla cell injections in the UK. Funding is required to create an MHRA licensed facility in which HairClone could prepare its cell therapy. Depending on the company’s ability to raise funds and create a licensed lab space, the DP cell therapy could potentially become available to patients in the UK by the end of 2020.
Cassiopea – The company developing the topical anti-androgen Breezula met with the FDA on November 13, 2019 to discuss the launch of a phase 3 clinical trial. The trial is expected to begin in Q1 2020 and is slated to last 6 months. As of now, results from this trial are estimated to read out in Q4 2020 and could lead to market approval in 2021.
Shiseido & Replicel – Replicel has recently stated that it is engaging Shiseido about releasing results from the RCH-01 trial which took place in Japan. As the results were due in 2019, it is virtually impossible to think that the holdout can last much longer. One way or another we will get clarity or closure regarding Shiseido’s trial in 2020.
Cosmetic & Over The Counter Treatments In 2020
Giuliani Pharma – In September 2019, Giulani Pharma gave an update regarding the development of a WAY-316606 product for hair growth. The company decided to go for the cosmetic regulatory route and is researching several analog molecule equivalents to WAY-316606 to create a product with. According to a lead scientist at Giuliani, a small pilot human trial has been initiated with one of the candidate molecules and results are expected around the beginning of the new year. Regardless of how the first trial turns out, Giuliani has multiple molecules in their repertoire and is committed to seeing the research through. Look for an update on this development in Q1 2020.
Applied Biology – AB-103 is listed as a “minoxidil adjuvant therapy” on Applied Biology’s pipeline page. In late 2019, Dr. Andy Goren of Applied Biology has stated his company is planning to release this product in the form of a shampoo. This shampoo is designed to help those who do not respond to minoxidil to get a response and is expected to enhance results in those who are already minoxidil responders. An estimated release of the product is Q3 2020.