Pfizer Reports Positive Phase 3 Results For LITFULO In Nonsegmental Vitiligo
(RTTNews) - Pfizer Inc. (PFE) announced topline results from two pivotal Phase 3 trials of LITFULO in patients with nonsegmental vitiligo, showing that the studies met their co-primary endpoints with significant improvements in facial and total body repigmentation compared to placebo at Week 52.
Vitiligo is a chronic autoimmune disease in which the immune system attacks melanin-producing cells, leading to a loss of pigment and visible white patches on the skin. Nonsegmental vitiligo (NSV), the most common form, can affect highly visible areas such as the face, neck, and hands, often impacting patients' quality of life well beyond cosmetic concerns.
The Phase 3 program, the largest to date evaluating an oral systemic therapy for NSV included the TRANQUILLO study in patients aged 12 years and older and TRANQUILLO 2 in adults. Both the 50 mg and 100 mg doses of LITFULO demonstrated clinically meaningful improvements over placebo on the Vitiligo Area Scoring Index (VASI).
Michael Vincent, M.D., Ph.D., Chief Inflammation & Immunology Officer, Pfizer, said LITFULO was internally discovered and has a unique mechanism of action targeting TEC family kinases and JAK3. He noted that the positive results build on Pfizer's dermatology expertise and prior experience with LITFULO in alopecia areata, reinforcing confidence in its potential as a new oral systemic treatment option for adults with NSV.
Based on these findings, Pfizer intends to submit global regulatory filings for LITFULO as a potential new oral systemic therapy in NSV for adults. If approved, it could become the first oral systemic treatment designed to restore and maintain skin pigmentation in adults living with the condition.
PFE has traded between $23.11 and $28.75 over the past year. The stock closed Wednesday's trading at $25.15, down 0.40%. In pre-market trading the stock is at $25.00, down 0.64%.
