Concert Races to Create Alopecia Treatments Based on JAK Inhibition
Another announcement has proved the race to develop the first treatment for autoimmune hair loss that is approved and licensed by appropriate medical regulatory boards, is now picking up speed.
Concert Pharmaceuticals, Inc. - one of the two front-runners in the area of treatment development for Alopecia Areata - issued a press release stating that it has now enrolled all 90 volunteers taking part in its latest clinical trial.
This is a Phase 2a trial which will investigate an FDA-fast-tracked drug known as CTP-543 as a potential treatment for mild to severe forms of Alopecia Areata.
Chief Development Officer of Concert Pharmaceuticals, James Cassella, Ph.D., says: “The speed with which we enrolled the trial speaks to the significant unmet need for alopecia areata and interest in this program. We are grateful to the patients who volunteered to participate in our trial.”
Whilst Alopecia Areata treatment - often involving the use of formulations of topical medications currently approved for use on male and female pattern baldness - is available for people aged 16 years and over with the mild phenotype which affects the scalp only, more extensive iterations presently have no effective options. These include Alopecia Totalis, which causes baldness of the entire head, including loss of facial hair, eyelashes and eyebrows, and Alopecia Universalis, which causes the body to lose all hair from head to toe.
What pharmaceutical companies are currently exploring involves drugs - topical and oral - which may treat all phenotypes, including these unserved and often distressing forms. Although these autoimmune hair loss conditions can affect men, women and children, available data suggests that treatments are being tested on adults.
Concert's CTP-543 drug is a topical substance and will be tested as part of a Part 2a double-blind, randomised, placebo-controlled clinical trial with sequential dosing. What this essentially means is that some participants will use the actual CTP-543 medication, whilst others will use a placebo; who gets which one was chosen at random and neither group knows if they are using the real thing or an inactive substitute. Of those who receive the active CTP-543 treatment, half will receive 4mg strength solutions and the rest will receive 8mg versions. The solutions will be applied directly to the scalp twice per day in each instance.
Primary outcomes will be measured at the 24 week usage mark, using the severity of alopecia tool (SALT). At this point doses may be amended to also explore the effects of using 12 mg strength CTP-543 twice daily.
Data from the initial findings is expected to be released at some point between October and December 2018, with a follow-up Phase 2b trial starting in 2019.
Concert Pharmaceuticals is undoubtedly one of the big names racing to development effective severe alopecia areata treatments; the other is Aclaris Therapeutics. Aclaris has been amassing a large patent portfolio through exclusively licensing a suite of janus kinase inhibition drugs, known as JAK inhibitors, from Columbia University in New York. Researchers from the university's medical school have been investigating the potential of various JAK inhibitor drugs and discovered a range which have shown significant hair regrowth results for patients with Alopecia Totalis and Alopecia Universalis - including regrowth of eyebrows and facial hair.
The difference between the drugs involved in each company's trials is that Aclaris/Columbia medications are all JAK inhibitors - including ruxolitinib, tofacitinib and baricitinib. JAK inhibitors work on the principle that janus kinases influence the resting period of the hair growth cycle - the Telogen phase - so by using drugs known to inhibit these, hairs are promoted to the active growth, Anagen phase. Thus preventing hair loss and encouraging hair regrowth.
Meanwhile, Concert's CTP-543 is made from a deuterated form of ruxolitinib. As Concert's team explains it, the company's 'approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy'. It does this by using a proprietary DCE Platform® (deuterated chemical entity platform) to create novel medicines.
Deuterium chemistry allows scientists to replace one or more hydrogen atoms within a drug's molecule with a heavier, stable isotope deuterium, thereby modifying the original drug - in this case, ruxolitinib. Despite it currently being a licensed blood disorder medication, going by the brand name of Jakafi in the USA - ruxolitinib was discovered by Columbia University School of Medicine researchers to also promote hair regrowth in cases of extreme alopecia areata.
Concert claims, 'Deuterium modification of ruxolitinib was found to alter its human pharmacokinetics in ways which may enhance its use as a treatment for alopecia areata'.
There are currently concerns regarding whether - if any do fulfil the relevant testing and licensing requirements to become commercially available for prescription use - JAK inhibitors will be affordable. Some reports suggest these novel hair loss solutions may be prohibitively expensive for many and - due to some insurance companies classing Alopecia Areata as a 'cosmetic issue' - may not be covered by medical insurance in the USA, nor offered by the UK's National Health Service. Whether these worries are valid, and if they also apply to Concert's proposed treatment, remains to be seen. But the fact that scientists are so close to developing a treatment for conditions which can have such a serious impact on people's lives, for the first time ever, remains an exciting prospect.
Concert Pharmaceuticals, Inc. - one of the two front-runners in the area of treatment development for Alopecia Areata - issued a press release stating that it has now enrolled all 90 volunteers taking part in its latest clinical trial.
This is a Phase 2a trial which will investigate an FDA-fast-tracked drug known as CTP-543 as a potential treatment for mild to severe forms of Alopecia Areata.
CTP-543 alopecia areata treatment
Whilst Alopecia Areata treatment - often involving the use of formulations of topical medications currently approved for use on male and female pattern baldness - is available for people aged 16 years and over with the mild phenotype which affects the scalp only, more extensive iterations presently have no effective options. These include Alopecia Totalis, which causes baldness of the entire head, including loss of facial hair, eyelashes and eyebrows, and Alopecia Universalis, which causes the body to lose all hair from head to toe.
What pharmaceutical companies are currently exploring involves drugs - topical and oral - which may treat all phenotypes, including these unserved and often distressing forms. Although these autoimmune hair loss conditions can affect men, women and children, available data suggests that treatments are being tested on adults.
Concert's CTP-543 drug is a topical substance and will be tested as part of a Part 2a double-blind, randomised, placebo-controlled clinical trial with sequential dosing. What this essentially means is that some participants will use the actual CTP-543 medication, whilst others will use a placebo; who gets which one was chosen at random and neither group knows if they are using the real thing or an inactive substitute. Of those who receive the active CTP-543 treatment, half will receive 4mg strength solutions and the rest will receive 8mg versions. The solutions will be applied directly to the scalp twice per day in each instance.
Primary outcomes will be measured at the 24 week usage mark, using the severity of alopecia tool (SALT). At this point doses may be amended to also explore the effects of using 12 mg strength CTP-543 twice daily.
Data from the initial findings is expected to be released at some point between October and December 2018, with a follow-up Phase 2b trial starting in 2019.
JAK inhibitors versus deuterated ruxolitinib
The difference between the drugs involved in each company's trials is that Aclaris/Columbia medications are all JAK inhibitors - including ruxolitinib, tofacitinib and baricitinib. JAK inhibitors work on the principle that janus kinases influence the resting period of the hair growth cycle - the Telogen phase - so by using drugs known to inhibit these, hairs are promoted to the active growth, Anagen phase. Thus preventing hair loss and encouraging hair regrowth.
Meanwhile, Concert's CTP-543 is made from a deuterated form of ruxolitinib. As Concert's team explains it, the company's 'approach starts with previously studied compounds, including approved drugs, in which deuterium substitution has the potential to enhance clinical safety, tolerability or efficacy'. It does this by using a proprietary DCE Platform® (deuterated chemical entity platform) to create novel medicines.
Deuterium chemistry allows scientists to replace one or more hydrogen atoms within a drug's molecule with a heavier, stable isotope deuterium, thereby modifying the original drug - in this case, ruxolitinib. Despite it currently being a licensed blood disorder medication, going by the brand name of Jakafi in the USA - ruxolitinib was discovered by Columbia University School of Medicine researchers to also promote hair regrowth in cases of extreme alopecia areata.
Concert claims, 'Deuterium modification of ruxolitinib was found to alter its human pharmacokinetics in ways which may enhance its use as a treatment for alopecia areata'.
There are currently concerns regarding whether - if any do fulfil the relevant testing and licensing requirements to become commercially available for prescription use - JAK inhibitors will be affordable. Some reports suggest these novel hair loss solutions may be prohibitively expensive for many and - due to some insurance companies classing Alopecia Areata as a 'cosmetic issue' - may not be covered by medical insurance in the USA, nor offered by the UK's National Health Service. Whether these worries are valid, and if they also apply to Concert's proposed treatment, remains to be seen. But the fact that scientists are so close to developing a treatment for conditions which can have such a serious impact on people's lives, for the first time ever, remains an exciting prospect.
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