Pfizer says its oral drug LITFULO significantly improved facial and total-body repigmentation in people with nonsegmental vitiligo in two Phase 3 trials, with benefits continuing to increase through 52 weeks.

 

The results, presented at the 35th European Academy of Dermatology and Venereology (EADV) Annual Congress in Vienna, could pave the way for Pfizer to seek regulatory approval for LITFULO as a potential new systemic treatment for adults with nonsegmental vitiligo.

 

The company said the TRANQUILLO 2 and TRANQUILLO trials — described by Pfizer as the largest Phase 3 program to date evaluating an oral systemic therapy for nonsegmental vitiligo — showed statistically significant improvements in facial and total-body repigmentation compared with placebo.

 

Pfizer plans to submit the findings to regulators worldwide, including the U.S. Food and Drug Administration and European Medicines Agency.

 

“LITFULO has dual selectivity for JAK3 and the TEC family kinases, signals that immune cells use to attack pigment-producing cells in the skin, so it addresses a root cause of nonsegmental vitiligo rather than its visible effects alone. 

 

"Across the largest Phase 3 program to date evaluating an oral systemic therapy for nonsegmental vitiligo, both TRANQUILLO 2 and TRANQUILLO demonstrated strong and increasing improvements in facial and total body repigmentation over time and also improved patients’ own perception of facial and overall disease severity. We look forward to discussing these results with regulators to bring this potential option to patients as soon as possible," said Michael Vincent, Chief Inflammation & Immunology Officer, Pfizer.

 

In TRANQUILLO 2, 21.86% of patients receiving 100 mg of LITFULO achieved at least a 75% improvement in facial vitiligo at Week 52, compared with 2.40% receiving placebo.

 

In TRANQUILLO, 12.47% of patients receiving 50 mg achieved the same benchmark, compared with 2.48% on placebo.

 

For total-body repigmentation, 13.02% of patients on 100 mg LITFULO in TRANQUILLO 2 achieved at least a 50% improvement, compared with 2.40% on placebo. In TRANQUILLO, 8.98% of patients on 50 mg reached that threshold, compared with 1.98% on placebo.

 

Pfizer said improvements in both facial and total-body vitiligo scores emerged as early as Week 24 and continued to increase through Weeks 36 and 52.

 

Patients receiving LITFULO also reported reductions in perceived facial and overall disease severity. The company said more patients described their vitiligo as “a lot less” or “no longer” noticeable by Week 52 compared with placebo.

 

The trials also showed greater disease stabilization among patients receiving ritlecitinib from Week 24 onward, according to Pfizer.

 

“Nonsegmental vitiligo is a disease that can have a substantial burden on patients’ lives beyond the visible symptoms on their skin. It is a chronic autoimmune disease, yet patients often face stigma because it is trivialized as a condition that affects only skin appearance. 

 

"It can progress unpredictably, often across highly visible areas, and for decades people living with vitiligo have relied on limited available treatment options. Research has shown that LITFULO (ritlecitinib) not only significantly improved facial and total body repigmentation, but also resulted in greater disease stabilization compared to the placebo. 

 

"The results solidify the potential of LITFULO to support a new treatment paradigm rooted in systemic treatment that can address underlying disease drivers for people living with nonsegmental vitiligo," said Iltefat Hamzavi, Senior Staff Physician, Department of Dermatology, Henry Ford Health and Hamzavi Dermatology Specialists.

 

The two pivotal Phase 3 studies enrolled 2,174 patients across 271 sites worldwide.

 

TRANQUILLO 2 evaluated once-daily 100 mg LITFULO in 1,567 adults, while TRANQUILLO evaluated once-daily 50 mg in 607 patients aged 12 and older. Pfizer said the 50 mg assessment in TRANQUILLO 2 was exploratory and descriptive.

 

The primary measures in the U.S. studies were the percentage of patients achieving at least 75% improvement in facial vitiligo and at least 50% improvement in total-body vitiligo at Week 52.

 

Pfizer said the safety profile observed in patients with nonsegmental vitiligo was consistent with LITFULO’s established safety profile in alopecia areata, with no new safety signals identified.