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Pfizer Phase 2b/3 clinical trial of Ritlecitinib for the treatment of hair loss have outstanding results
Pfizer Phase 2b/3 trials of Ritlecitinib for hair loss have outstanding results. Alopecia areata is an autoimmune disease characterized by patchy alopecia. It is the second highest incidence of alopecia in the world, second only to androgenic alopecia. Alopecia areata is the partial or complete loss of hair on the scalp, face, or other parts of the body caused by immune cells attacking healthy hair follicles.
The average age of onset of alopecia areata is between 25 and 35 years old, but it also affects the elderly, children, and adolescents, and can be seen in men and women and all races. Alopecia areata is associated with poor health-related quality of life for many patients, who may suffer from severe psychological disorders, including depression and anxiety. However, there is no drug or therapy approved by the FDA for the treatment of alopecia areata.
On August 4, 2021, Pfizer announced that its developed drug for alopecia areata, Ritlecitinib, has achieved positive top-line results in a Phase 2b/3 ALLEGRO clinical trials for the treatment of alopecia areata.
In this phase 2b/3 clinical trial, both 30mg and 50mg doses of Ritlecitinib reached the primary efficacy endpoint of improving scalp hair regeneration. After 6 months of treatment, the proportion of patients with scalp hair loss ≤20% was significantly higher than that in the placebo group.
In this randomized, placebo-controlled, double-blind clinical trial, a total of 718 alopecia areata patients aged 12 years and older participated. These alopecia areata patients had a scalp alopecia of more than 50% and had symptoms of alopecia areata for at least six months. The patients were randomly assigned to four groups, namely Ritlecitinib 50mg, 30mg, 10mg, and placebo group.
The primary endpoint was based on the proportion of patients with scalp hair loss ≤ 20% at week 24. Among them, the 30mg and 50mg doses of Ritlecitinib both reached the primary efficacy endpoint of improving scalp hair regeneration.
Ritlecitinib, a JAK3/TEC inhibitor developed by Pfizer, can inhibit IL-15 and CD8 cytokine signal transduction, these two cytokines are important factors that drive the immune system to kill hair follicle cells. Ritlecitini has achieved significant results in the previous phase 2 clinical trials and has been approved by the FDA as a breakthrough therapy. This innovative treatment has already begun clinical research in China. The therapy is still in research on leukoplakia, rheumatoid arthritis, Crohn’s disease and ulcerative colitis.
Ritlecitinib molecular structure
In addition, in March 2021, Eli Lilly and Incyte jointly announced that its oral JAK inhibitor Baricitinib reached the primary endpoint in a phase 3 clinical trial for the treatment of adult patients with severe alopecia areata. After 36 weeks of treatment, compared with the placebo group, the patient’s hair regrowth was significantly improved.
(source:internet, reference only)