When it comes to developing new methods of treating hair loss
, though many potential drugs and devices may start clinical trials, it is often the case that they are never heard of again.
This can happen for a number of reasons, including the treatments being tested fail to meet the appropriate standards for safety, tolerability and efficacy. It may also be due to financial issues - whether there is insufficient funding for the necessary research to continue, or where the end product would be prohibitively expensive - especially where other, more affordable treatments already exist.
One area of hair loss research which has been, and remains, consistent in its progress updates is that of janus kinase inhibition - the use of JAK inhibitor drugs - to treat all forms of alopecia areata
Now, Concert Pharmaceuticals, a Massachusetts-based biopharmaceutical company, has released its latest progress report regarding the oral alopecia areata drug, CTP-543.
Oral hair loss solution for severe alopecia areata
Alopecia areata is an autoimmune disorder with many different phenotypes
in which the immune system attacks follicles, pausing the hair growth cycle
in its resting phase and causing patchy hair loss to total baldness as a result. This can be temporary or permanent but its duration cannot be predicted; the conditions may also recur once they have cleared up.
Though it is not actually a JAK inhibitor, CTP-543, a deuterium-modified analog of ruxolitinib, is based on one. It is a version of ruxolitinib, a JAK inhibiting drug currently used to treat various blood disorders and cancers, which is also known by the brand name Jakafi, and selectively represses Janus kinases 1 and 2. JAK enzymes form part of the JAK-STAT pathway whereby cells used by signalling proteins known as cytokines help to control various bodily functions, including immune and inflammatory responses.
Medical researchers in the USA first discovered ruxolitinib's ability to regrow hair loss caused by even the most extreme form of alopecia areata - alopecia universalis
- in 2014. The drug showed impressive regrowth results with the hair returning to completely bald scalps within a matter of months. It has been in development since then and is now about to start the second part of its Phase 2a trial - the penultimate stage
before it can be approved by the necessary medical authorities, such as the MHRA and FDA, and released for prescription use.
"Progressing as planned"
In the press release dated 12th February 2018, detailing enrolment for the second cohort of its Phase 2a clinical trial into CTP-543, Concert also outlined how it was making headway. It confirmed that an independent Data Monitoring Committee assessing the safety data from the first part of its Phase 2a trial recommended Concert's researchers continue and also begin the second cohort of this trial. The topline data outcomes from both the first and second cohorts of the Phase 2a trial are expected to be released between September and December 2018.
Commenting on the momentum, James Cassella, PhD, Chief Development Officer of Concert Pharmaceuticals said: “We are pleased that the CTP-543 trial is progressing as planned as we continue to advance the evaluation of our innovative product candidate for alopecia areata. There is a significant unmet medical need for alopecia areata and we intend to be at the forefront of advancing a new oral treatment for patients.”
For adults with the scalp-only form, there are already alopecia areata treatment
options available. At Belgravia
clients presenting with the condition's signature rounded patches of hair loss all over their scalp, or even just the odd bald spot, are often treated with topical applications of high strength minoxidil
. Though minoxidil is only MHRA-licensed and FDA-approved for the treatment of male and female pattern baldness, it is widely acknowledged as benefiting a number of other hair loss conditions, including alopecia when it only affects the scalp; it should not be used on the body or face.
Should it continue to advance as hoped, this oral drug may be something of a triple threat - being both the first effective treatment for alopecia totalis and alopecia universalis, the first oral treatment for alopecia areata and the first alopecia areata treatment to gain FDA-approval. Due to the need for an efficient treatment for the most severe forms of alopecia areata its development is currently being fast-tracked by the FDA.
The drug's estimated availability is unknown, though its competitors - Aclaris Therapeutics and Columbia University medical school - are aiming for a release date
of 2020/2021, assuming everything goes to plan with the rest of the clinical trials, for their oral and topical JAK inhibitors
which are also being developed to treat all forms of autoimmune alopecia.