Trial Into Oral ATI-50001 Drug as Severe Alopecia Areata Treatment

US pharmaceutical company Aclaris is fast establishing itself as one of the leading lights in the race to bring new treatments to market for people with the autoimmune disorder Alopecia Areata, which causes sudden, patchy hair loss.

The Pennsylvania-based company hit the headlines last year when it entered into a deal to acquire Vixen therapeutics, a company set up by Dr Angela Christiano and colleagues at Columbia University in New York, where some of the most ground-breaking work in new Alopecia Areata treatments has been taking place.

Shown promise

The buzzword is “JAK inhibitor” a suite of existing drugs originally designed to treat certain cancers, rheumatoid arthritis and other conditions, but which have shown promise at regrowing hair in people with severe Alopecia Areata and its related conditions, too.

At the time of the Vixen acquisition, Aclaris surprised the hair loss community by stating that they hoped that JAK inhibitors may also one day be used as a new treatment option for the genetic conditions Male Pattern Baldness and Female Pattern Hair Loss, too. Up until then, JAK inhibitors had only been mentioned in connection with Alopecia Areata-related hair loss.

Aclaris’ most recent announcement is that its Investigational New Drug application for ATI-50001, an oral JAK inhibitor tablet designed for the potential treatment of Alopecia Totalis and Alopecia Universalis, two extreme forms of Alopecia that both lead to total hair loss of the head, has cleared its 30-day review period by the US Food and Drug Administration.

This now paves the way for a Phase 1 clinical trial, which will take place over the coming months and for which 12 volunteer test subjects have been recruited.

“We are excited to have achieved this important milestone,” said Christopher Powala, Chief Operating Officer, via a company press release.  “We look forward to developing ATI-50001 as a potential oral treatment for these severe phenotypes of Alopecia Areata.”

Christopher Powala, COO of Aclaris

To say that Aclaris seems keen on bringing JAK inhibitor-based products for Alopecia Areata and its related conditions to market would be something of an understatement. As well as licensing a patent portfolio from Columbia University, Aclaris has licensed several other patents and patent applications involving novel selective JAK 1/3 inhibitors, including a patent portfolio from Rigel Pharmaceuticals that covers ATI-50001 as well as ATI-50002, a topical formulation also being developed as a potential treatment for Alopecia Areata.

Japanese patent

Additionally, they have licensed a patent portfolio from JAKPharm and Key Organics which is directed to novel covalently binding, highly-selective JAK 3 inhibitors. Interestingly, Aclaris states that the Columbia portfolio includes "a recently issued patent in Japan directed to pharmaceutical compositions comprising ruxolitinib, baricitinib or other JAK inhibitors for use in treating Alopecia Areata, androgenetic alopecia and other hair loss disorders."

It should be noted that, whilst there are effective alopecia areata treatment options already available for adults and over 16's, there are no such reliable Alopecia Universalis and Totalis treatments. For this reason, the hair loss community is watching all new developments - including the JAK inhibitor research - with interest, although it is expected to be several years before any new drugs, either topical or oral, make it to market.