Pfizer has started a phase 2b/3 clinical trial of PF-06651600, an oral JAK3 inhibitor to treat patients with moderate to severe alopecia areata.
Alopecia areata is a chronic autoimmune skin disease, which makes hair loss on the scalp, face and body. At present, there are no approved therapies for this autoimmune skin disease.
The PF-06651600 has achieved the primary efficacy endpoint in Phase 2a study, which showed that it improved hair regrowth on the scalp relative to baseline at week 24 as measured by the Severity of Alopecia Tool (SALT) score.
The investigational candidate also reached all secondary endpoints in the study, in addition to meeting the primary efficacy endpoint.
Last September, the company secured breakthrough therapy designation from the US Food and Drug Administration (FDA) to treat alopecia areata. The approval was based on the totality of the data and the emerging clinical profile.
The PF-06651600 is also being assessed for rheumatoid arthritis, Crohn’s disease and ulcerative colitis.
Pfizer will enroll up to 660 patients in the double-blind, placebo-controlled and dose-ranging phase 2b/3 clinical trial to assess the safety and effectiveness of PF-06651600 in adults and adolescents aged 12 years and older with 50% or greater scalp hair loss.
The company has multiple kinase inhibitors in clinical trials across multiple indications, including the PF-04965842 investigational selective JAK1 inhibitor in phase 3 clinical trial to treat atopic dermatitis and the PF-0670084 investigational tyrosine kinase 2(TYK2)/JAK1 inhibitor to treat soriasis, Crohn’s disease, ulcerative colitis and alopecia areata.
Pfizer global product development inflammation and immunology chief development officer Michael Corbo said: “We are proud to start this global pivotal Phase 2b/3 trial for PF-06651600 in patients with alopecia areata. We hope this potential treatment will be able to help patients who currently have limited treatment options.
“Including our JAK3 program, Pfizer has several selective kinase programs in the clinic with studies spanning across rheumatology, gastrointestinal disorders, and medical dermatology, where we aspire to deliver potentially transformative medicines to those living with chronic autoimmune and inflammatory conditions.”