Incyte Announces Full Results From Phase 3 TRuE-V Program Evaluating Ruxolitinib Cream (Opzelura™) in Patients With Vitiligo
Incyte (Nasdaq:INCY) today announced the full 24-week results from its pivotal Phase 3 TRuE-V clinical trial program investigating ruxolitinib cream (Opzelura™), a topical JAK inhibitor, in adolescent and adult patients (age ≥12 years) with nonsegmental vitiligo. These data will be presented today as a late-breaking oral presentation (Abstract #D3T01.2A) at the European Academy of Dermatology and Venereology (EADV) 30th Congress, held virtually from September 29-October 2, 2021.
Building on the previously announced positive topline results from the TRuE-V program, findings from the Week 24 analysis showed treatment with 1.5% ruxolitinib cream twice daily (BID) resulted in greater improvement to vehicle for the primary and all key secondary endpoints in both the TRuE-V1 and TRuE-V2 studies. Results, which were consistent across both studies, showed:
- At Week 24, 29.9% of patients applying ruxolitinib cream achieved ≥75% improvement from baseline in the facial Vitiligo Area Scoring Index (F-VASI75), the primary endpoint.
- More than 51% of patients applying ruxolitinib cream achieved ≥50% improvement from baseline in F-VASI (F-VASI50), and more than 15% of patients applying ruxolitinib cream achieved ≥90% improvement from baseline in F-VASI (F-VASI90), key secondary endpoints.
- Additional key secondary endpoints were met, including a significantly greater proportion of patients achieving ≥50% improvement from baseline in total body Vitiligo Area Scoring Index (T-VASI50) and a Vitiligo Noticeability Scale (VNS) response with application of ruxolitinib cream compared to vehicle, and a significant improvement on percentage change from baseline in facial body surface area (F-BSA) with application of ruxolitinib cream compared to vehicle.
“We are pleased to share the full 24-week results from our pivotal Phase 3 TRuE-V program for the first time with the global dermatology community at EADV, which resulted in significant improvements in facial and total body repigmentation in vitiligo patients treated with ruxolitinib cream,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “These positive results reinforce the potential for ruxolitinib cream as a meaningful treatment option for people suffering from vitiligo, and we look forward to working with regulators to bring the first approved medical treatment that directly addresses repigmentation to patients in the U.S. and Europe.”
The overall safety profile of ruxolitinib cream in vitiligo was consistent with previous study data. In the TRuE-V studies, patients using ruxolitinib cream did not report clinically significant application site reactions. Treatment-emergent adverse events were consistent with previous studies, with no serious treatment-related adverse events reported.
“The skin depigmentation associated with vitiligo can have a profound impact on a person’s life and patients are in need of additional treatment options,” said David Rosmarin, M.D., Vice Chair of Research and Education, Dermatology Department at Tufts Medical Center. “I am extremely encouraged about the potential of ruxolitinib cream, as evidenced by the clinically meaningful improvements in repigmentation shown in the pivotal trials, and the potential benefits it may bring for my patients.”
As previously disclosed, based on these findings Incyte expects to submit 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) before the end of 2021. In September 2021, Opzelura™ (ruxolitinib) cream was approved by the FDA for the short-term and non-continuous 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.
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 has been shown to drive inflammation involved in the pathogenesis and progression of vitiligo. It affects approximately 0.5% to 2.0% of the population globally1 and there are no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA)-approved drug therapies for the treatment of vitiligo. It can occur at any age, although many patients with vitiligo will experience initial symptoms before the age of 202.
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 approximately 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, 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 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. The studies also track the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.
About 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.
Additionally, ruxolitinib cream is in Phase 3 development for the treatment of adolescents and adults with vitiligo in the TRuE-V clinical program. Results from this Phase 3 program were recently announced.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.
Opzelura is a trademark of Incyte.
IMPORTANT SAFETY INFORMATION
OPZELURA cream is for use on the skin only. Do not use OPZELURA cream, in your eyes, mouth or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: OPZELURA cream contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA.
OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA.
Increased risk of death from all causes, including sudden cardiac death, has happened in people taking JAK inhibitors by mouth.
Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Some people have had lymphoma and other cancers while taking JAK inhibitors by mouth, especially if they are a current or past smoker. Some people have had skin cancers while taking OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA.
There is an increased risk of major cardiovascular events such as heart attack, stroke or cardiac death in people with cardiovascular risk factors and who are current or past smokers while using JAK inhibitors to treat inflammatory conditions.
Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening.
Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen.
Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides.
Before starting OPZELURA, tell your healthcare provider if you:
- have an infection, are being treated for one, or have an infection that keeps coming back
- have diabetes, chronic lung disease, HIV, or a weak immune system
- have or had TB, or have been in close contact with someone with TB
- have had shingles (herpes zoster) or hepatitis B or C
- live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
think you have an infection or have symptoms of an infection such as:
- fever, sweating, or chills
- muscle aches
- cough or shortness of breath
- blood in your phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinating more often than usual
- feeling very tired
- have ever had any type of cancer, or are a current or past smoker
- have had blood clots in the veins of your legs or lungs in the past
- have high cholesterol or triglycerides
- have or have had low white or red blood cell counts
- are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463.
- are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose.
After starting OPZELURA:
- Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have.
Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat
- nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
- Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing.
- Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath or fever.
Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of OPZELURA include: pain or swelling in your nose or throat (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea).
These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.
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.
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.
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding Incyte’s TRuE-V clinical program, whether and when ruxolitinib cream might be approved to treat patients with vitiligo , the potential for success of such treatment, Incyte’s expectations with respect to submitting marketing applications for ruxolitinib cream for the treatment of adolescent and adult patients with vitiligo to regulators and Incyte’s Dermatology program generally, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by the FDA, EMA and other regulatory authorities; the efficacy or safety of the Company’s products; the acceptance of the Company’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended June 30, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.
1 Kruger C. A review of the worldwide prevalence of vitiligo in children/adolescents and adults. Int J Dermatol. 2012;51(10):1206-1212.
2 Rodrigues M. New Discoveries in the pathogenesis and classification of vitiligo. J Am Acad Dermatol. 2017; 77:1-13.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
+1 302 498 6171
+1 302 274 4324
+1 302 274 4773
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Peru Holds a Ribbon Cutting Ceremony at Its Pavilion at Dubai Expo and Wins 4 World Travel Awards22.10.2021 19:15:00 CEST | Press release
The Dubai World Expo took place in an electrifying musical atmosphere where thousands of attendees were captivated by the variety of artistic, musical and cultural expressions that characterize the different regions of Peru. All this was part of the inauguration of the Peru Pavilion at the most important cultural event in the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211022005454/en/ Peru inaugurated its Pavilion at Expo 2020 Dubai and received four awards from the “Tourism Oscars.” (Photo: Business Wire) The Peru Pavilion was inaugurated by the Commissioner General for Peru at the Expo, Amora Carbajal, and Najeeb Mohammed Al-Ali, Executive Director of Expo 2020 Dubai, in front of official representatives from different country pavilions. “The purpose of the pavilion is to offer a complete learning experience about ancient Peruvian wisdom throughout the visit, communicating the importance of the heritage, biodive
Schlumberger Announces Third-Quarter 2021 Results22.10.2021 12:50:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the third-quarter 2021. Third-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeSept. 30, 2021Jun. 30, 2021Sept. 30, 2020SequentialYear-on-yearRevenue* $5,847 $5,634 $5,258 4% 11% Income (loss) before taxes - GAAP basis $691 $542 $(54) 28% n/m Net income (loss) - GAAP basis $550 $431 $(82) 28% n/m Diluted EPS (loss per share) - GAAP basis $0.39 $0.30 $(0.06) 30% n/m Adjusted EBITDA** $1,296 $1,198 $1,018 8% 27% Adjusted EBITDA margin** 22.2% 21.3% 19.4% 90 bps 280 bps Pretax segment operating income** $908 $807 $575 12% 58% Pretax segment operating margin** 15.5% 14.3% 10.9% 120 bps 460 bps Net income, excluding charges & credits** $514 $431 $228 19% 126% Diluted EPS, excluding charges & credits** $0.36 $0.30 $0.16 20% 125% Revenue by Geography International $4,675 $4,511 $4,210 4% 11% North America* 1,129 1,083 1,034 4% 9% Other 43 40 14 n/m n/m $5,847 $5,634 $5,258 4% 11% *Schlumberger dive
Disruptive.Asia: Huawei's Ryan Ding and Peng Song Discuss How Operators Can Leverage Connectivity to Unlock New Growth22.10.2021 12:30:00 CEST | Press release
Disruptive.Asia reported that Ryan Ding and Peng Song stressed the growing importance of connectivity in driving industry growth and generating value amid a rapidly evolving landscape at the 7th Ultra-Broadband Forum (UBBF 2021) in Dubai, which is jointly hosted by the UN Broadband Commission and Huawei. Ding, Executive Director of the Board and President of the Carrier Business Group, Huawei, said that connectivity has made it possible to innovate, especially in a digital age where increasing efficiency has become paramount. The pandemic has also ushered a paradigm shift in connectivity, as homes turned into multi-functional centers for education, work, and business. It became increasingly clear that connectivity not only drives digital economies forward but also maintains the functioning of society. Peng, President of the Global Carrier Marketing & Solution Sales Department, Huawei, said that looking at connectivity through Huawei's C.A.F (Coverage, Architecture and Fusion) model can
Suzano Brings Its Target for Capturing 40 Million Tons of Carbon From the Atmosphere Forward To 202522.10.2021 12:19:00 CEST | Press release
Suzano, the world's leading eucalyptus pulp producer and a global benchmark in the manufacture of bioproducts developed from eucalyptus, announces today that it has revised one of its 14 long-term goals – collectively known as Suzano’s “Commitments to Renewing Life”*. Suzano’s goal to remove 40 million tons of carbon from the air by 2030 has been brought forward by five years to 2025. With this revision, Suzano reinforces its capacity to make an even more positive contribution to the planet's climate by achieving net carbon removals from the atmosphere at a faster pace than previously expected. The new five-year target will be supported by the expansion of Suzano’s forest covering which will involve both an uplift in commercial planting operations and setting aside new designated conservation areas that were previously anthropized. Alongside these improvements, Suzano will maintain its focus on reducing carbon emissions across its own operations and supply chain and will continue to im
AntChain Launches Its First Security Chip and New Blockchain Platform Powered by Privacy Computing Technology22.10.2021 12:01:00 CEST | Press release
AntChain, the flagship technology brand of Ant Group, today unveiled two new products at the Apsara Conference 2021 in Hangzhou – the FAIR platform and the T1 security chip – to ensure the security and trustworthiness of data flows within blockchain networks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211022005166/en/ Yan Ying, technical director of AntChain, unveiled the FAIR platform at the Apsara Conference on October 22, 2021. (Photo: Business Wire) Based on AntChain’s upgraded technical architecture, the FAIR platform natively integrates privacy-preserving computation (PPC) and blockchain technologies in a unified platform, unleashing the value of data flows over their entire lifecycle. FAIR is designed to address pain points in multi-party collaboration on data flows, which is increasingly common on the industrial internet. It replaces traditional “PPC plus blockchain” dual-system architecture, integrating the two
Total Telecom: Maximizing the Value of Connectivity22.10.2021 12:00:00 CEST | Press release
Total Telecom reported that industry leaders gathered recently at Ultra-Broadband Forum 2021, organized by UN Broadband Commission and Huawei, held in Dubai to discuss building future-proof networks sustainably. Total Telecom thinks that the expectations from digital connectivity have been redefined in the last one year. From conducting financial transactions online to remote factory management, the digital way of life is becoming pervasive. "Connectivity reshaped how we live and work when the pandemic hit in 2020. Connectivity is more than an expansion of functions, it is an emotional bond. As long as there is connectivity, there is a bond. Where there is connectivity, there is innovation. It presents us with unlimited possibilities. I believe in our shared mission to create a connected world," says Ryan Ding, Executive Director of the Board, President of the Carrier BG, Huawei, in his inaugural address. The C.A.F (Coverage, Architecture and Fusion) model is emerging as a way for the
Egle Therapeutics Raises 40 Million € Series a to Develop First-In-Class T-regulatory Cells Therapies Based On Treg-starvers22.10.2021 11:30:00 CEST | Press release
Egle Therapeutics SAS (Egle), an emerging biotechnology company focused on developing First-In-Class immunotherapies targeting immune suppressor regulatory T-cells (Tregs) for oncology and autoimmune diseases, today announces that it has completed a €40M ($46.4M) Series A financing. The Series A was co-led by LSP and Bpifrance through their InnoBio 2 fund. Fund+, Bioqube Ventures and Takeda Ventures, Inc. also participated in this round. Egle Therapeutics was founded in early 2020 with a vision to become a game changer in the field of Tregs immunomodulation through the unique concept of Tregs starving and specifically targeting the most immunosuppressive ones. Spun out of Institut Curie, Egle’s scientific foundation leverages unprecedented, computational-based, IL-2 modified variants and newly tumor-associated Treg targets to build a furnished pipeline of First-In-Class immunocytokines against Tregs. The new capital will be used primarily to advance 2 leads assets into the clinic and f