Pfizer reports positive Phase 3 results for LITFULO in nonsegmental vitiligo
Pfizer announced that its oral JAK3/TEC inhibitor LITFULO achieved statistically significant skin repigmentation in two Phase 3 studies of nonsegmental vitiligo. In the TRANQUILLO 2 trial, 21.86% of participants receiving 100 mg reached at least a 75% improvement in facial vitiligo, versus 2.40% on placebo. In the lower‑dose TRANQUILLO study, 12.47% of patients on 50 mg met the same facial endpoint, compared with 2.48% for placebo. The company said it will file the data with U.S. and European regulators.
Why it matters
Pfizer states the data support regulatory submissions, which could create a new approved indication and generate additional revenue if the therapy receives approval.
Key facts
- 1In the TRANQUILLO 2 study, 21.86% of patients given 100 mg LITFULO achieved at least a 75% reduction in facial vitiligo area versus 2.40% on placebo. marketscreener.com
- 2In the TRANQUILLO study, 12.47% of patients receiving 50 mg LITFULO reached the same facial improvement, compared with 2.48% on placebo. marketscreener.com
- 313.02% of the 100 mg group achieved a 50% improvement in total body vitiligo scoring, versus 2.40% for placebo. marketscreener.com
- 48.98% of the 50 mg group achieved the total‑body endpoint, compared with 1.98% on placebo. marketscreener.com
- 5Treatment‑emergent adverse events were reported in 67.7% of the 100 mg cohort and 62.0% of placebo participants. marketscreener.com
- 6Adverse events occurred in 81.0% of the 50 mg group and 77.1% of the corresponding placebo group. marketscreener.com
Summary written by AlphAI from 9 of 9 sources. Not investment advice. Figures are as stated by the linked sources.