Pfizer has reported positive top-line data from the Phase IIb/III ALLEGRO clinical trial of its drug, ritlecitinib, in alopecia areata patients.
Alopecia areata is an autoimmune disease, in which the immune system attacks the hair follicles leading to hair loss on the scalp and may even impact the face and body.
The randomised, placebo-controlled, double-blind trial analysed ritlecitinib in alopecia areata patients aged 12 years and above.
Subjects enrolled in the trial had 50% or more scalp hair loss, including those with complete scalp hair loss or alopecia totalis, and complete scalp, face and body hair loss or alopecia universalis. They also had an alopecia areata episode that lasted for six months to ten years.
Participants received oral once-daily ritlecitinib 50mg or 30mg, with or without a four-week initial treatment of 200mg once-daily; ritlecitinib 10mg; or placebo.
The trial met the primary efficacy goal of scalp hair regrowth improvement, Pfizer noted.
After 24 weeks of therapy, a statistically significantly higher proportion of subjects receiving 50mg or 30mg ritlecitinib had 20% or less scalp hair loss versus placebo.
In the trial, the 10mg ritlecitinib dosing group was not investigated for statistically significant efficacy as against placebo.
Ritlecitinib’s safety profile was in line with already reported trials.
Nasopharyngitis, headache and upper respiratory tract infection were the most common adverse events observed in the trial.
Pfizer Global Product Development inflammation an immunology chief development officer Michael Corbo said: “We are pleased by these positive results for ritlecitinib in patients with alopecia areata, a devastating and complex autoimmune disease for which there are currently no US Food and Drug Administration or European Medicines Agency approved treatments.
“We look forward to bringing this potential new treatment option to patients living with alopecia areata as soon as possible.”
The company plans to submit the latest data, along with further results, from the ALLEGRO-LT trial to seek regulatory approval in the future.
Last month, Pfizer and Valneva concluded participant enrolment in the Phase II VLA15-221 trial of an investigational vaccine candidate, VLA15, for Lyme disease.