Incyte, one of the pharmaceutical companies currently investigating Janus Kinase (JAK) inhibitor treatments for hair loss
caused by severe forms of the autoimmune disorder Alopecia Areata
, has noted an estimated Phase III completion date of 25th March 2022.
Baricitinib development timeline
These latest Incyte trials will feature three arms, with doses of oral baricitinib (also referred to as LY3009104) in high and low doses, and a placebo being administered as a control. All participants will be aged 18 to under 60 for men, and under 70 for women, with severe or 'very severe' Alopecia Areata that affects more than half the scalp, has been on-going for less than eight years and has shown no signs of spontaneous regrowth. Hair growth will be monitored using the SALT method at the 36 week mark, when primary data will be gathered.
According to documentation lodged via Incyte's trial registration on the clinicaltrials.gov
database, Phase 2 then Phase 3 trials are due to commence on 24th September 2018 at various centres across the USA. The initial data is expected on 4th December 2020, with the final studies then scheduled to end on 25th March 2022.
After this, should the necessary regulatory bodies agree that Incyte has presented sufficient evidence to show the drug's safety, tolerability and efficacy in the treatment of Alopecia Totalis and Alopecia Universalis, the necessary green lights will be given. How long this stage could take depends entirely on the relevant agencies, however, the FDA in particular has already expressed its desire to fast-track
other treatments for these severe forms of autoimmune alopecia given there are currently no approved treatments for these conditions.
Ruxolitinib connection (Jakafi)
Incyte is already responsible for producing Jakafi - the brand name for the JAK inhibitor, ruxolitinib
- which is currently used to treat conditions such as myelofibrosis and certain cancers.
However, it was shown in research by Columbia University Medical Centre to have potentially significant hair growth applications in cases of Alopecia Areata and its more extreme phenotypes, Alopecia Totalis and Alopecia Universalis
. These involve patchy hair loss of the scalp only, baldness of the head, and becoming completely hairless from head to toe, respectively.
Successful completion of Phase III trials is the last stage of development
that must be passed before medical regulatory bodies, such as the MHRA and FDA, licence or approve a drug for prescription, allowing it to then be released.
Although it was previously thought that JAK inhibitors for autoimmune hairloss would be ready to release by 2021/2022
, this was based on information from another company - Aclaris
- which is heavily involved in their development.
Interestingly, Aclaris - due to its exclusive licensing deal with the holders, the Trustees of Columbia University in the City of New York - already holds various patents
relating to the treatment of various forms of hair loss - including all forms of autoimmune alopecia - using baricitinib
and many other JAK inhibitor drugs.
Given the connection between Columbia University's medical team and ruxolitinib discoveries in relation to severe Alopecia Areata treatment, there may be an existing relationship between the two institutions though this is not mentioned in the latest trial registration information.