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Pfizer: Phase 2b/3 Ritlecitinib Trial Meets Primary Efficacy Endpoint In Alopecia Areata Patients

Drug major Pfizer Inc. (PFE) Wednesday announced positive top-line results from the Phase 2b/3 ALLEGRO trial evaluating oral once-daily ritlecitinib in patients with alopecia areata.

It is an autoimmune disease driven by an immune attack on the hair follicles that causes hair loss on the scalp and can also affect the face and body. At present, there are no U.S. Food and Drug Administration or FDA or European Medicines Agency approved treatments for the disease.

Pfizer said the Phase 2b/3 ALLEGRO trial met the primary efficacy endpoint of improving scalp hair regrowth. All participants entered the study with at least 50 percent scalp hair loss due to alopecia areata, as measured by the Severity of Alopecia Tool score.

In the trial, Ritlecitinib 50 mg and 30 mg achieved the primary efficacy endpoint of the study, namely the proportion of patients with less than or equal to 20 percent scalp hair loss after six months of treatment versus placebo.

Ritlecitinib was granted Breakthrough Therapy designation from the U.S. FDA for the treatment of alopecia areata in September 2018.

The company said it will submit the full results from the study for future scientific publication and presentation. These data, together with data that will become available from ALLEGRO-LT, will form the basis for planned future regulatory filings.

Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, said the company expects to bring the potential new treatment option to patients living with alopecia areata as soon as possible.

Ritlecitinib is also being evaluated for vitiligo, rheumatoid arthritis, Crohn's disease and ulcerative colitis.

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