Incyte Announces 52-Week Data From the Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo

- Use of ruxolitinib cream (Opzelura™) resulted in further improvement in facial and total body repigmentation at Week 52

- Results will be featured as an oral presentation in a late-breaking abstract session at the 2022 American Academy of Dermatology (AAD) Annual Meeting

WILMINGTON, DE, March 26, 2022 I Incyte (Nasdaq:INCY) today announced new 52-week results from its pivotal Phase 3 TRuE-V clinical trial program evaluating ruxolitinib cream (Opzelura™), a topical JAK1/JAK2 inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. These data were presented today as an oral presentation in a late-breaking abstract session (Session #S026 – Late-Breaking Research: Clinical Trials) at the 2022 American Academy of Dermatology (AAD) Annual Meeting, held from March 25-29 in Boston.

The 52-week results build on the previously announced positive 24-week results and include data from the 24-week double-blind and 28-week treatment extension periods of the Phase 3 TRuE-V1 and TRuE-V2 studies. Findings from the Week 52 analysis showed that patients applying 1.5% ruxolitinib cream twice daily (BID) had clinically meaningful facial and total body repigmentation as shown by greater proportions of patients reaching the facial and total body Vitiligo Area Scoring (F-VASI and T-VASI, respectively) endpoints at Week 52.

Specifically, efficacy results of patients who applied ruxolitinib cream from Day 1 showed:

  • At Week 52, approximately 50% of patients achieved ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75) compared to the F-VASI75 improvement from baseline reported for these patients at Week 24 (the primary endpoint of the study) which was approximately 30%.
  • At Week 52, approximately 75% of patients achieved ≥50% improvement in F-VASI (F-VASI50), and nearly one-third (approximately 30%) achieved ≥90% improvement in F-VASI (F-VASI90) compared to the Week 24 response rates for F-VASI50 and F-VASI90 which were approximately 51% and 15%, respectively.
  • Additionally, a greater proportion of patients at Week 52 achieved ≥50% improvement in total body Vitiligo Area Scoring Index (T-VASI50), and over one-third of patients achieved a Vitiligo Noticeability Scale (VNS) response. Further improvement on percentage change from baseline in facial body surface area (F-BSA) with application of ruxolitinib cream was also observed.

Results at Week 52 in crossover patients (those who received 28 weeks of treatment with ruxolitinib cream after initial treatment with vehicle cream) were consistent with Week 24 data in patients who applied ruxolitinib cream from Day 1.

The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data – there were no clinically significant application site reactions or serious treatment-related adverse events related to ruxolitinib cream.

“The positive 52 week results in facial and total body repigmentation seen with ruxolitinib cream in our pivotal Phase 3 TRuE-V program, which were presented today at the 2022 AAD meeting, add to the robust data showing ruxolitinib cream has the potential to be a meaningful treatment option for those with vitiligo,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte.

“Vitiligo is a serious and chronic autoimmune condition that can severely impact a person’s life and has very limited treatments,” said David Rosmarin, M.D., Vice Chair of Research and Education, Department of Dermatology at Tufts Medical Center. “These results are extremely encouraging and highlight the clinical potential of ruxolitinib cream for patients with vitiligo.”

As previously announced, based on the 24-week results, Incyte submitted marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo (age ≥12 years) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The FDA Prescription Drug User Fee Act (PDUFA) target action date is July 18, 2022.

About Vitiligo

Vitiligo is a chronic autoimmune disease characterized by depigmentation of skin that results from the loss of pigment-producing cells known as melanocytes. Over-activity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo. It affects approximately 1.9-2.8 million people in the United States1 and can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 30.2

About TRuE-V

The TRuE-V clinical trial program includes two Phase 3 studies, TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), evaluating the safety and efficacy of ruxolitinib cream in patients with vitiligo.

The studies each enrolled over 300 patients (age ≥12 years) who have been diagnosed with non-segmental vitiligo and have depigmented areas including at least 0.5% of the body surface area (BSA) on the face, ≥0.5 facial Vitiligo Area Scoring Index [F-VASI] score, at least 3% BSA on nonfacial areas, ≥3 total body Vitiligo Area Scoring Index [T-VASI] score and total BSA involvement (facial and nonfacial) of up to 10%. Participants were randomized into two arms: 1.5% ruxolitinib cream twice daily (BID) and vehicle control for the 24-week double-blind period. Patients who successfully completed baseline and Week 24 assessments, including those that received vehicle control during the double-blind phase, were offered treatment extension with 1.5% ruxolitinib cream BID for an additional 28 weeks.

The primary endpoint of both studies in the TRuE-V program is the proportion of patients achieving F-VASI75, defined as at least a 75% improvement from baseline in the F-VASI score at Week 24. Key secondary endpoints include: the percentage change from baseline in facial BSA (F-BSA) at Week 24, the proportion of patients achieving F-VASI50 (at least 50% improvement from baseline in the F-VASI), F-VASI90 (at least 90% improvement from baseline in the F-VASI) and T-VASI50 (at least 50% improvement from baseline in the T-VASI) at Week 24 and the proportion of patients achieving a Vitiligo Noticeability Scale (VNS) score of 4 (a lot less noticeable) or 5 (no longer noticeable) at Week 24. Additional secondary endpoints included the proportion of patients achieving F-VASI75, F-VASI90, T-VASI50 and T-VASI75 (at least 75% improvement from baseline in the T-VASI) at Week 52.The studies also track the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.

For more information on the TRuE-V studies, please visit https://clinicaltrials.gov/ct2/show/NCT04052425 and https://clinicaltrials.gov/ct2/show/NCT04057573.

About Ruxolitinib Cream (Opzelura™)

Ruxolitinib cream (Opzelura) a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura. On October 28, 2021, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement.

About Incyte Dermatology

Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.

About Incyte

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

1 Gandhi K, et al. Prevalence of vitiligo among adults in the United States. JAMA Dermatol. 2022;158(1):43-50.
2 Frisoli M, et al. Vitiligo: mechanisms of pathogenesis and treatment. Annu. Rev. Immunol. 2020;38(1):621-648.

SOURCE: Incyte

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