Oral Medicine for Alopecia Totalis and Universalis Starts Trial
Two of the most frequently asked questions Belgravia hair specialists have been receiving in recent years are 'when will there be a treatment for Alopecia Totalis and Alopecia Universalis?' and 'when will JAK inhibitor Alopecia treatments be released?'.
The reason for this is that, whilst Alopecia Areata treatment is possible in cases of the scalp-only form of this autoimmune disorder, there are currently no truly effective hair loss solutions for the more severe forms of Alopecia Areata - namely, Alopecia Totalis and Alopecia Universalis. These cause total baldness of the head, in the case of Totalis, whilst people with Alopecia Universalis have no hair at all anywhere on their scalp, face or body.
JAK inhibitors, or Janus kinase inhibitors to give them their full name, are a suite of drugs which were discovered to have hair growth properties after the drug tofacitinib was used experimentally to treat a patient with plaque psoriasis. The young man also happened to have Alopecia Universalis - both being autoimmune conditions - and had not grown any hair in around 20 years. Following just X weeks of treatment, whilst there were some improvements to his psoriasis, he had regrown a full head of hair.
Since then tofacitinib and other JAK inhibitor drugs have been in clinical development as researchers try to find the safest, most effective doses and solutions in order to minimise potential side effects whilst maximising hair regrowth potential for all forms of autoimmune alopecia.
Updates on trials and findings have been uncharacteristically forthcoming, not to mention regular, from companies at the forefront of these investigations, namely Aclaris Therapeutics Inc, and Concert Pharmaceuticals.
The latest news on JAK inhibitor treatments comes from Aclaris; on 27th June 2018, the company announced that the first patient taking part in its Phase 2 ATI-501 Oral Suspension treatment trial had started treatment. Other participants are still being recruited, however, all 80 volunteers taking part in the randomised, multi-centre trial (reference: AUAT-201) will have diagnoses of stable Alopecia Totalis or Alopecia Universalis.
They will be treated for six months, receiving either the ATI-50 solution or a placebo for the duration. Results will be measured at Week 24, with the primary goal being to establish increased mean changes in hair growth for each patient, using the Severity of Alopecia Tool (SALT). Other factors, including changes to hair density measured via the Alopecia Density and Extent Score (ALODEX) and observations from both clinicians and patients, will also contribute to the study's overall findings.
This information appears to bust the original assumptions that the oral treatment being developed would be in tablet form. An 'oral suspension' generally relates to liquid medication containing small particles of a drug which does not dissolve.
“This trial is the first step in evaluating the potential clinical benefit of ATI-501 oral suspension in treating patients with the alopecia totalis and alopecia universalis forms of alopecia areata,” said Dr. Stuart Shanler, Chief Scientific Officer of Aclaris. “This is an important step forward in understanding the clinical utility of our JAK inhibitors in patients with AA.”
Columbia University's medical department has been making the key discoveries and granting its patents to these treatments exclusively to Aclaris, which has helped it to build a portfolio of JAK inhibitor drugs. At least one of these is known to be a topical JAK inhibitor treatment, with an estimated release date for both drug formats currently being set at 2021.
This timeline is based on all necessary clinical trial stages going smoothly, to time, and being successfully completed in order to obtain the crucial medical regulatory board licenses and approvals, such as those from the UK's MHRA and the FDA in the USA.
Other drug companies including Pfizer and Concert Pharmaceuticals are also developing potential Alopecia Totalis and Universalis treatments. The FDA has even fast-tracked Concert's proposed treatment's trials, in recognition of the need to address this unmet need for affected patients. However, updates have been less forthcoming from these companies so far, with both currently being actively engaged in clinical trials.
The reason for this is that, whilst Alopecia Areata treatment is possible in cases of the scalp-only form of this autoimmune disorder, there are currently no truly effective hair loss solutions for the more severe forms of Alopecia Areata - namely, Alopecia Totalis and Alopecia Universalis. These cause total baldness of the head, in the case of Totalis, whilst people with Alopecia Universalis have no hair at all anywhere on their scalp, face or body.
JAK inhibitors, or Janus kinase inhibitors to give them their full name, are a suite of drugs which were discovered to have hair growth properties after the drug tofacitinib was used experimentally to treat a patient with plaque psoriasis. The young man also happened to have Alopecia Universalis - both being autoimmune conditions - and had not grown any hair in around 20 years. Following just X weeks of treatment, whilst there were some improvements to his psoriasis, he had regrown a full head of hair.
Updates on trials and findings have been uncharacteristically forthcoming, not to mention regular, from companies at the forefront of these investigations, namely Aclaris Therapeutics Inc, and Concert Pharmaceuticals.
Oral JAK inhibitor medicine
The latest news on JAK inhibitor treatments comes from Aclaris; on 27th June 2018, the company announced that the first patient taking part in its Phase 2 ATI-501 Oral Suspension treatment trial had started treatment. Other participants are still being recruited, however, all 80 volunteers taking part in the randomised, multi-centre trial (reference: AUAT-201) will have diagnoses of stable Alopecia Totalis or Alopecia Universalis.
They will be treated for six months, receiving either the ATI-50 solution or a placebo for the duration. Results will be measured at Week 24, with the primary goal being to establish increased mean changes in hair growth for each patient, using the Severity of Alopecia Tool (SALT). Other factors, including changes to hair density measured via the Alopecia Density and Extent Score (ALODEX) and observations from both clinicians and patients, will also contribute to the study's overall findings.
This information appears to bust the original assumptions that the oral treatment being developed would be in tablet form. An 'oral suspension' generally relates to liquid medication containing small particles of a drug which does not dissolve.
“This trial is the first step in evaluating the potential clinical benefit of ATI-501 oral suspension in treating patients with the alopecia totalis and alopecia universalis forms of alopecia areata,” said Dr. Stuart Shanler, Chief Scientific Officer of Aclaris. “This is an important step forward in understanding the clinical utility of our JAK inhibitors in patients with AA.”
Topical solution also in development
Columbia University's medical department has been making the key discoveries and granting its patents to these treatments exclusively to Aclaris, which has helped it to build a portfolio of JAK inhibitor drugs. At least one of these is known to be a topical JAK inhibitor treatment, with an estimated release date for both drug formats currently being set at 2021.
This timeline is based on all necessary clinical trial stages going smoothly, to time, and being successfully completed in order to obtain the crucial medical regulatory board licenses and approvals, such as those from the UK's MHRA and the FDA in the USA.
Other drug companies including Pfizer and Concert Pharmaceuticals are also developing potential Alopecia Totalis and Universalis treatments. The FDA has even fast-tracked Concert's proposed treatment's trials, in recognition of the need to address this unmet need for affected patients. However, updates have been less forthcoming from these companies so far, with both currently being actively engaged in clinical trials.
The Belgravia Centre
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