FDA Approval Sought for Severe Alopecia Areata ATI-50001 Drug Trial

As part of its pledge to develop JAK inhibitor hair loss treatments, Aclaris Therapeutics, Inc. has announced the submission of an Investigational New Drug Application to the FDA.

The application is specifically for its newly developed ATI-50001, a drug which has been engineered for the treatment of alopecia universalis and alopecia totalis. These are the two most extreme types of the autoimmune disorder alopecia areata (AA). Though, whilst AA is often temporary and causes patchy hair loss on the scalp only, AT and AU cause total baldness of the head, and, in the case of AU, the body also.

Whilst there are effective alopecia areata treatment options available now, there are currently no treatments available for alopecia totalis or universalis. This is currently the subject of many clinical trials as researchers aim to finally develop a way to help people with these severe forms of hair loss.

Oral and topical formulations

In a press release, Aclaris announced its plans to conduct a 'human pharmacokinetic/pharmacodynamic (pK/pD) study to evaluate the safety of ATI-50001 in healthy volunteers'. The drug will be taken in oral, tablet form.

Dates, locations and eligibility criteria for the trial have not yet been announced as the FDA's approval to carry out the trial, is obviously needed before this can go any further.

Further to the ATI-50001 investigations, Aclaris is also developing a topical formulation known as ATI-50002 to treat alopecia areata. Both of these treatments are based on novel janus kinase inhibitors - better known as JAK inhibitors - which Aclaris has been acquiring the exclusive rights to in recent years. The company has acquired sole access to relevant drug portfolios from Rigel Pharmaceuticals, JAKPharm and Key Organics in its search to develop JAK inhibitors.

Most exciting, perhaps, is the announcement that it has also 'exclusively licensed a patent portfolio from Columbia University directed to methods of using JAK inhibitors for the treatment of alopecia areata, androgenetic alopecia, and other dermatological conditions. This portfolio includes a recently issued U.S. patent directed to methods of treating alopecia areata, androgenetic alopecia and other hair loss disorders by administering ruxolitinib, and a recently issued patent in Japan directed to pharmaceutical compositions comprising ruxolitinib, baricitinib or other JAK inhibitors for use in treating alopecia areata, androgenetic alopecia and other hair loss disorders.'

Thorough testing is crucial

As clinical trials are still in their early stages, it is somewhat doubtful that the company will be ready to release these drugs in the near future. Due to the high stakes involved when dealing with people's health, it takes many years of safety, tolerability and efficacy testing to develop new drugs, including hair loss treatments. However, from the study findings to date, the area of JAK inhibitors does seem to be a potent one.

"If they can prove these drugs have no serious side effects - a concern due to some of the currently known side effects listed for these drugs when used to treat different conditions other than hair loss - and are both safe and effective over the long-term, this will be an incredible breakthrough," advises senior Belgravia hair loss specialist, Leonora Doclis (pictured).

"It is likely to be most beneficial to men and women - and possibly children as we do not yet know which age range these treatments will be suitable for - with Alopecia Totalis and Universalis. Giving them the opportunity to grow their hair back - just like men and women with genetic hair loss conditions and alopecia areata have right now - will be a marvellous thing. My hope is that the studies are not rushed in order to bring this to market quickly - it is obviously important that everything is thoroughly investigated when developing new drugs."

Alopecia areata can affect men, women and children of any race and at any age although, according to Aclaris, two-thirds of those affected are under 30 years old when they develop the condition. Whilst it does not hurt or have any symptoms other than hair loss, it is not simply a 'cosmetic' problem. Autoimmune hair loss can have drastic, negative effects on a person's self-esteem, which may result in mental health issues.