Lilly, Incyte Gaining Ground in the Fight against Alopecia Areata

By Daniel Ojeda, Ph.D.

On October 30th, 2020, Eli Lilly and Incyte presented the results of their Phase 2 clinical trial for Baricitinib as a treatment for Alopecia Areata. The data presented during the annual Fall Clinical Dermatology meeting showed that the highest dose of Baricitinib significantly reduced hair loss in over 50% of the patients.

In the US alone, up to 6.8 million people suffer from Alopecia Areata (AA), which is an autoimmune disease that leads to hair loss in the scalp, face, and sometimes in other parts of the body. In March 2020, Baricitinib received the designation of FDA’s breakthrough therapy marking a milestone for this disease. There is no FDA approved drug to treat AA; however, corticosteroid injections, topical minoxidil applications, and other anti-inflammatory medications and hair growth stimulants have been shown to help only in some patients.

As explained by Abby Ellison, Research Director at the National Alopecia Areata Foundation, “Although there has been some progress in our understanding of this disease, there remains a significant unmet need to improve treatment strategies and the options available to people with alopecia areata. Today’s news builds upon this progress and provides hope to people living with alopecia areata.”

Baricitinib and BRAVE-AA1 Clinical Trial

Baricitinib, marketed under the name OLUMIANT was developed by Incyte and is a potent inhibitor of the JAK family of proteins. JAK proteins have been shown to increase the production of pro-inflammatory molecules, which can contribute to pathogenesis in inflammatory and autoimmune diseases.

In 2009, Eli Lilly and Incyte enter a collaboration to develop and commercialize Baricitinib to treat patients with inflammatory and autoimmune diseases.

The efficacy and safety of Baricitinib in AA patients were tested during the Phase 2 clinical trial known as BRAVE-AA1. For this study, patients were randomly assigned to one of four groups, 1-mg, 2-mg, 4-mg, or placebo. After 36 weeks, patients in the 2-mg and 4-mg had significantly lower hair loss than the placebo group. Only 3.6% of patients in the placebo group had 20% hair loss or lower versus 33.3% and 51.9% of patients in the 2-mg and 4-mg groups respectively.

Based on these results, Baricitinib will now move to the Phase 3 portion of the trail.

As expressed by Dr. Lotus Mallbris, vice president of immunology development at Lilly. “The results of this study underscore Baricitinib potential in alopecia areata, and we look forward to continuing the clinical development program for Baricitinib in hopes of becoming the first FDA approved treatment option for adults with AA.”

JAK Inhibitors Against Inflammatory and Autoimmune Diseases

Eli Lilly is not the only company trying to use a JAK inhibitor against AA. Back in 2019, Pfizer announced Phase 2B/3 clinical trials to evaluate PF-06651600, their JAK inhibitor, in patients with severe AA. Other companies testing a JAK inhibitor against AA in Phase 2 clinical trials include Reistone Biopharma Company Limited (SHR0302), Aclaris Therapeutics (ATI-501), CoNCERT Pharmaceuticals (CTP-543). Although Lilly is currently leading the race, it reminds to be seen if any of the competitors have higher efficacy in preventing hair loss.

Related Article: Eli Lilly Launches Phase 3 Trial with Baricitinib for COVID-19 Patients

References

1. https://investor.lilly.com/news-releases/news-release-details/fall-clinical-dermatology-2020-lilly-and-incyte-showcase
2. https://www.naaf.org/alopecia-areata
3. https://www.naaf.org/alopecia-areata/alopecia-areata-treatments
4. https://investors.pfizer.com/investor-news/press-release-details/2019/Pfizer-Initiates-Phase-2b3-Clinical-Trial-for-PF-06651600-an-Oral-JAK3-Inhibitor-for-the-Treatment-of-Patients-with-Moderate-to-Severe-Alopecia-Areata/default.aspx
5. https://investor.aclaristx.com/news-releases/news-release-details/aclaris-therapeutics-announces-phase-2-clinical-trial-ati-501
6. https://www.concertpharma.com/product-pipeline/ctp-543/

Author

Daniel Ojeda