One of the most truly significant avenues of hair loss
research over the last few years has been the area of janus kinase (JAK) inhibition.
Researchers across the world, though mostly in the USA and associated to the medical arm of Columbia University in New York, have been trying to exploit the JAK-STAT
pathway in order to develop an effective treatment for some of the most severe hair loss conditions
. These include autoimmune disorders which cause total baldness of the head, and from head to toe, respectively - Alopecia Totalis and Alopecia Universalis
, which are currently untreatable.
Dr Angela Christiano of Columbia University, USA, has been instrumental in the development of JAK inhibitor hair loss treatment
As the drugs move along the clinical trial process - currently working towards an estimated initial release date of 2020/2021 - more information about their progress is released. The latest milestone is that Aclaris Therapeutics, Inc. has been assigned two new patents by the United States Patent and Trademark Office for the use of certain JAK inhibitors as hair loss treatments.
These have been granted in relation to treating both autoimmune alopecia
and androgenetic alopecia, more commonly known as male pattern baldness
and female pattern hair loss
Treating alopecia and inducing hair growth
Aclaris Therapeutics, Inc. pledged its support
to developing JAK inhibitors for hair loss early on. It has been acquiring a vast patent portfolio over the past few years, clearly hoping to be the first to bring these drugs to the alopecia market ahead of competitors such as Pfizer
, who are also currently conducting clinical trials into JAK inhibition and hair loss. The American company is described as being 'a dermatologist-led biopharmaceutical company focused on identifying, developing and commercialising innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology'.
U.S. Patents No. 9,737,469 and 9,730,877 have been granted to The Trustees of Columbia University in the City of New York, who are the patent owners. They, in turn, have licensed them exclusively to Aclaris just as they did with earlier U.S. Patents
from this project, which were awarded in April 2017. Both cover methods of use and administration of various JAK inhibitor drugs in relation to treating different hair loss conditions.
U.S. Patent No. 9,737,469 relates to the use of baricitinib
in 'inducing hair growth and for treating hair loss disorders such as alopecia areata
and androgenetic alopecia'. It covers 10 separate issued claims, including specific methods of using baricitinib to treat forms of alopecia areata - understood to be Alopecia Totalis and Alopecia Universalis.
U.S. Patent No. 9,730,877 relates to the use of a number of JAK inhibitor drugs, including tofacitinib,
to treat male and female pattern hair loss. This contains 22 individual claims.
Both patents expire in November 2031.
Dr. Neal Walker, President and Chief Executive Officer of Aclaris, said of the announcement: “We are extremely pleased with the continued development of the patent portfolio we exclusively licensed from Columbia. These new issuances continue to expand the breadth and depth of our JAK inhibitor intellectual property portfolio covering methods of use for certain JAK inhibitors for the treatment of hair loss disorders. The issuance of these patents is another successful step in the development of a robust patent portfolio relating to JAK inhibition and hair loss.”
Oral and topical hair loss treatments
Aclaris is known to be developing two products currently known as ATI-50001 - an oral medication - and ATI-50002, which has a topical formulation.
The development of both oral and topical drugs mimics the formats of currently available - and the only MHRA licensed and FDA approved
options - for treating genetic hair loss in men and women.
These hair loss treatments
comprise one oral option
suitable for men only and one topical solution
- available in various formulations - which is suitable for both men and women.
Additionally, both men and women can use supplementary hair growth supporting products
to help stimulate the follicles and promote good scalp and hair health.
Furthermore, treatment for alopecia areata
when in its moderate scalp-only form, is also often possible.
It is likely that some of the JAK inhibitor drugs being developed for topical, rather than oral, use is in a bid to reduce their side-effect profile. Concerns have been raised by medical agencies in the past regarding tofacitinib in particular - currently available as a prescription rheumatoid arthritis drug under the brand name Xeljanz - due to the seriousness of its side-effects
. This is likely to be something researchers are working hard to reduce in order to achieve the necessary safety and tolerability standards needed to be eligible for eventual MHRA and FDA approval in the coming years.