Alopecia Areata Treatment Pipeline 2023
In this article we will cover the most prominent therapeutic candidates in the alopecia areata treatment industry in 2023.
Frontrunners To Market
In June 2022, Eli Lilly/Incyte received the FDA’s first ever approval for a systemic treatment for alopecia areata with their drug Olumiant. Alopecia areata, an auto-immune disorder which results in patchy and sometimes total hair loss, differs from “common” hair loss or pattern baldness which is driven by androgen sensitivity. Prior to this FDA approval designation, baricitinib was previously an FDA approved drug for other conditions and was prescribed off-label for AA.
Just days ago, Pfizer announced that its candidate for alopecia areata which has received “breakthrough” designation by the FDA, , ritlecitinib, met its endpoints in a phase 2b/3 study. Because of the breakthrough designation, Pfizer will be able to use data from the phase 2b/3 and from an ongoing long term study of ritlecitinib to file for FDA approval in the near future. Concert Pharmaceuticals has also reached a phase 3 trial for AA.
Alopecia Areata Pharmaceutical & Biotech Therapies In Development
AnaptysBio– Rosnilimab or ANB030 is a Anti-PD-1 agonist. It is currently being evaluated in a 45 patient phase 2 clinical trial in moderate to severe alopecia areata. Rosnilimab is administered through subcutaneous injection. The phase 2 “AZURE” trial is expected to produce clinical data in Q1 2023.
Arena Pharmaceuticals– Etrasimod is an oral selective S1P receptor modulator. It’s currently at the phase 2 stage for AA in Arena’s pipeline. It appears the company is looking for a commercial partner to initiate a trial with.
Bioniz Therapeutics– See Equillium.
Concert Pharmaceuticals– CTP-543 (deuterated ruxolitinib) is an oral inhibitor of JAK1/2. A phase 3 trial of CTP-543 was initiated in November 2020 and the company expects to report topline results in 2022.
Eli Lilly/Incyte– Baricitinib is an oral inhibitor of JAK1/2. It has completed two successful phase 3 trials and a new drug application is expected to be filed by the end of 2021. In June 2022, baricitinib became the first drug candidate to receive FDA approval for the treatment of severe AA.
Equillium–EQ101 is an IL-2/9/15 antagonist. In November 2022, Equillium announced the initiation of a phase 2 clinical trial of EQ101 in adults with moderate to severe alopecia areata.
HCW Biologics– HCW9302 is an IL-2-based immunotherapeutic being developed for AA. HCW’s pipeline page currently lists the program as currently working on IND-enabling studies for HCW9302. This means that when those studies are complete, HCW can bring this drug into FDA clinical trials.
地平线疗法/Q32 Bio– Bempikibart (formerly ADX-914), a partnered program between Q32 Bio and Horizon Therapeutics, is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP. In September 2023, the companies announced the initiation of a phase 2 clinical trial for bempikibart in adults with severe AA. Horizon Therapeutics also has listed in its pipeline daxdilimab, which similarly is a fully human monoclonal antibody against ILT7 that depletes certain dendritic cells. Daxdilimab is currently undergoing a phase 2 clinical trial in adults with moderate to severe AA which is expected to complete in 2024.
Legacy Healthcare– LH-8 or Coacillium is a botanical compound intended to treat pediatric alopecia areata. The company has announced positive results from its phase 2/3 trial for children and adolescents with moderate to severe alopecia areata, on its website. Subsequently, Legacy has applied for marketing approval which is currently under evaluation by the CHMP in Europe.
Nepsone– A preclinical-stage pharmaceutical company developing a topical and novel treatment for AA.
Pfizer– Ritlecitinib, an oral JAK3/TEC inhibitor, is Pfizer’s lead candidate for AA. The candidate has successfully completed a phase 2b/3 trial in August 2021 and a new drug application may be filed by Q1 2022. Pfizer also has an oral TYK2/JAK1 inhibitor, brepocitinib, in its pipeline for AA. Brepocitinib is listed at phase 2 but not currently enrolling for a clinical trial.
Reistone Biopharma– SHR0302 is an oral JAK1 inhibitor with high selectivity, according to the company’s website. A phase 2 trial with 94 participants was recently completed in July 2021.
Serpin Pharma–SP16 is a novel peptide therapeutic aimed at resolving inflammation. Serpin’s AA program is listed at proof of concept.
siRNAgen Therapeutics– A silencing-RNA therapeutic company with alopecia areata listed as a target in its pipeline. (note the pipeline listings have changed since this was written, however AA is still likely a target for this early stage company.)
TagCyx Biotechnologies– Developing a nucleic-acid based therapy for AA which is currently listed at the preclinical stage. A highly interesting additional tidbit, Cage Bio Inc. is listed as a partner for the AA program in TagCyx’s pipeline.Cage Biois a startup developing a novel technology which limits the systemic exposure of liquid formulations. This could be highly useful in the androgenic alopecia industry as well, for example, even in conjunction with established drugs like finasteride.
TIGO GmbH– A biotech company developing IFN-y receptor antagonists with AA as a highlighted indication target. The company is seeking strategic partnerships for their programs.
Zelgen Biopharmaceutical– Zelgen’s pipeline lists an oral JAK inhibitor for severe AA and a cream JAK inhibitor for mild to moderate AA.
It’s good to see so many new potential players working to find cures for alopecia areata, particularly a few outside the realm of JAK inhibitors. Please share this information and hope with those who you think would benefit from it.