Incyte Announces Positive Data from Phase 2b Trial of Ruxolitinib Cream in Patients with Atopic Dermatitis
Incyte Corporation (Nasdaq:INCY) today announced positive results from its randomized, dose-ranging, vehicle- and active-controlled Phase 2b study evaluating ruxolitinib cream in patients with atopic dermatitis (AD) who are candidates for topical therapy. The study, part of the True-AD clinical trial program, met its primary endpoint, demonstrating that ruxolitinib cream 1.5% administered twice daily (BID) significantly improved Eczema Area and Severity Index (EASI) scores – a measurement of the extent and severity of AD – from baseline versus vehicle control (non-medicated cream) at Week 4. Additionally, treatment with ruxolitinib cream 1.5% BID resulted in a rapid and sustained reduction in itch versus vehicle, a key secondary endpoint. These results were shared in an oral presentation today at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris, France.
“The positive results of this Phase 2 study demonstrate the potential of ruxolitinib cream to offer a novel, effective non-steroidal topical therapy to the millions of patients suffering from AD,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “We look forward to further advancing the True-AD clinical trial program for ruxolitinib cream and initiating Phase 3 registrational trials in this indication to further explore the potential of JAK inhibition to modulate inflammation and itch, and therefore provide much-needed relief to patients with this disease.”
Key study results included:
- Significantly improved EASI score in the ruxolitinib cream 1.5% BID arm versus vehicle at Week 4 (71.6 percent vs. 15.5 percent improvement; P<0.001), the primary endpoint, and improvement (meeting the criteria for non-inferiority) in EASI score versus the active control, triamcinolone 0.1% cream (a mid-potency topical corticosteroid), at Week 4 (71.6 percent vs. 59.8 percent improvement), a secondary endpoint.
- Significantly improved EASI scores in the ruxolitinib cream 1.5% BID arm versus vehicle at Weeks 2 and 8 (52.7 percent vs. 4.8 percent and 78.5 percent vs. 26.9 percent, respectively; P<0.001).
- Significantly greater changes in EASI score in the once daily (QD) ruxolitinib cream 1.5% and 0.5% arms versus vehicle at Week 4 (1.5% QD [67.0 percent vs. 15.5 percent improvement], 0.5% QD [52.2 percent vs. 15.5 percent improvement]; P<0.001).
- Significantly more Investigator’s Global Assessment (IGA) responders – a measure of disease severity – in the ruxolitinib cream 1.5% BID arm versus vehicle at Week 4 (38.0 percent vs. 7.7 percent; P<0.001), and greater IGA response rates across other ruxolitinib arms versus vehicle.
- Rapid and sustained reductions in itch numerical rating scale (NRS) score observed as early as within two days from the initiation of therapy (ruxolitinib cream 1.5% cream BID vs. vehicle, ‒1.8 vs. ‒0.2; P<0.0001), and a more pronounced reduction in itch with ruxolitinib cream 1.5% BID and QD than with triamcinolone cream 0.1% BID.
Ruxolitinib cream was well-tolerated at all dosage strengths and was not associated with clinically-significant application site reactions. All treatment-related adverse events were Grade 1 or Grade 2 in severity.
Ruxolitinib cream is the first JAK1/JAK2 inhibitor to exhibit positive results as a topical monotherapy in the AD patient population. Over-activity of the JAK signaling pathway has been shown to drive inflammation involved in the pathogenesis of AD. These data support the planned initiation of a global, pivotal Phase 3 program, for which preparations are already underway.
"There is no cure for AD, and it continues to be a major therapeutic challenge for patients, primary care providers and specialists. Though topical corticosteroids have been a mainstay in treatment of AD for decades, their utility has been limited due to significant side effects associated with long-term use,” said principal investigator of the trial, Brian Kim, M.D., M.T.R., F.A.A.D., Assistant Professor of Dermatology and Co-Director of the Center for the Study of Itch at Washington University School of Medicine in St. Louis, Missouri, USA. “There is an urgent need for new and innovative treatments for patients with this condition, which tends to be chronic. As a physician who treats patients with AD, I am encouraged by the potential of ruxolitinib cream to fill this gap.”
About Atopic Dermatitis
Atopic dermatitis (AD) is a common chronic disease characterized by inflammation of the skin. Approximately 11 million people in the United States have been diagnosed with AD, and the majority (10 million) have a mild or moderate form of the disease. Signs and symptoms of AD include skin rash and dry skin, and it can cause intense itching, scratching and lesions that may ooze or crust. Patients with AD are also more susceptible to bacterial, viral and fungal infections.
About the Study
The safety and efficacy of ruxolitinib cream in adults with atopic dermatitis (AD) were evaluated in an Incyte-sponsored randomized, dose-ranging, vehicle- and active- controlled Phase 2b study (NCT03011892), which began in December 2016 and completed in March 2018. The study, part of the True-AD clinical trial program, enrolled 307 adults (aged 18-70 years) diagnosed with AD for at least two years and who were candidates for topical therapy.
Patients with AD on 3 to 20 percent of their body surface area, with an IGA score of 2 to 3, were equally randomized across six treatment-arms, including: twice daily (BID) ruxolitinib 1.5% cream; once daily (QD) ruxolitinib 0.15%, 0.5% or 1.5% cream; vehicle (non-medicated cream); and active control (triamcinolone 0.1% cream [TAC], a mid-potency topical corticosteroid). All patients received eight weeks of blinded study treatment; the TAC arm received four weeks of TAC followed by four weeks of vehicle; and there was an additional four weeks of open-label ruxolitinib 1.5% cream BID.
The primary efficacy endpoint was mean percentage change from baseline in Eczema Area and Severity Index (EASI score) – a measurement of the extent and severity of AD – at Week 4 in the ruxolitinib 1.5% BID arm versus vehicle. Key secondary endpoints included percent change from baseline in EASI score at Week 4 in the other ruxolitinib cream arms versus vehicle BID and versus triamcinolone 0.1% cream; the proportion of patients achieving an IGA score of 0 (clear) to 1 (almost clear) with at least a 2-point improvement from baseline; the proportion of patients achieving at least a 75 percent improvement from baseline in EASI (EASI75); itch numerical rating scale (NRS); and safety through 12 weeks of dosing.
For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03011892.
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company's web site at www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including statements regarding the potential of ruxolitinib cream to meaningfully improve the outcomes of patients with atopic dermatitis and plans to initiate a pivotal study. These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including scheduling and related issues with respect to study initiation, unanticipated developments in and risks related to the efficacy or safety of ruxolitinib cream for the treatment of atopic dermatitis, the results of additional data and additional analyses of data from this study, actions taken by regulatory authorities, and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2018. Incyte disclaims any intent or obligation to update these forward-looking statements.
Om 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.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Pierre Fabre Receives EU Approval for BRAFTOVI® (encorafenib) + MEKTOVI® (binimetinib) in Adult Patients with Advanced BRAF-Mutant Melanoma20.9.2018 17:21 | Pressemelding
Pierre Fabre today announced that the European Commission (EC) has granted marketing authorisation for the combination of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.1,2 The EC decision is applicable to all 28 European Union (EU) member states plus Liechtenstein, Iceland and Norway. "We are extremely pleased that European patients with advanced BRAF-mutant melanoma will now have the combination of BRAFTOVI and MEKTOVI as a new treatment option”, said Frédéric Duchesne, President & CEO of the Pierre Fabre Pharmaceuticals Division. “All of us at Pierre Fabre are driven to make a real difference for patients. Bringing more than 30 years of oncology experience and our heritage in dermatology to our partnership with Array BioPharma, we have been able to harness our expertise in order to help men and women living with this devastating disease. Today’s
Clothesource Report Shows Retail Sales Aren’t Falling or Moving Online: Management’s Let Itself Get Misguided20.9.2018 17:19 | Pressemelding
According to a new Clothesource report, “The Emperors’ Clothes” retail sales aren’t falling, and they’re not leaving physical stores. Both the UK’s Office of National Statistics and the US Bureau of the Census report higher retail sales than ever – with sales in physical stores still growing every year. Retailers just need to rely on their own customer understanding, recapture their self-confidence, and rediscover their traditional frugality. Among recent front-page stories have been Sears in the US hinting it’s about to go under and profits at Britain’s John Lewis falling 99%. But the well run clothing retailers are prospering. Primark goes from strength to strength: the biggest clothing specialists on either side of the Atlantic (Inditex and TJX) have just upped their sales and profit forecasts. So it’s not about consumer purchasing: The main problem lies with management, says Clothesource CEO Mike Flanagan in a new report “The Emperors’ Clothes”. They’ve lost touch with their custom
BCW Names Latin America Market Leaders20.9.2018 16:23 | Pressemelding
BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced the appointment of market leaders in Latin America who will be responsible for business growth, client satisfaction and talent development. All market leaders report to Francisco Carvalho, President, Latin America, BCW. “BCW has a dominant presence in Latin America, thanks to Burson-Marsteller’s 40-year-history and expansive footprint across the region and Cohn & Wolfe’s strength in Brazil and Mexico,” said Carvalho. “This team has unmatched market knowledge, strong client relationships and deep commitment to talent, all of which is critical for our continued success in the region. Those strengths, together with our industry-leading expertise in delivering digitally driven integrated communications programs, make BCW a powerful partner for our clients.” All of BCW’s Latin America market leaders have been drawn from the legacy Burson-Marsteller organization and had been leading their respective markets, e
NavVis Achieves Breakthough 6D SLAM Indoor LiDAR Mapping With Velodyne’s 3D LiDAR Sensor20.9.2018 14:43 | Pressemelding
On April 18th, 2018, NavVis released their M6, a fully-integrated, cart-based system designed for large-scale indoor mapping. The M6 utilizes VLP-16 sensors by Velodyne LiDAR, Inc., which allows it to produce a 3D map of the surrounding environment. Six cameras capture 360° immersive imagery and photorealistic point-clouds, resulting in high-resolution mapped images. NavVis developed this product in response to their customers’ request for a more versatile and sophisticated system which could be used effectively with uneven terrain. In addition to AEC professionals, construction companies and manufacturers can also draw benefits from the higher data quality provided by this enhanced innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005560/en/ NavVis M6 is a fully-integrated, cart-based system designed for large-scale indoor mapping. (Photo: Business Wire) The M6 was developed by NavVis after customers requeste
Steve Bannon’s New Documentary Film Trump @War Launches Free Online Access20.9.2018 14:34 | Pressemelding
Trump @War in conjunction with its online distribution partner, The Western Journal, is pleased to announce that the full length HD feature film Trump @War is free and available to viewers worldwide at Trumpmovienow.com. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180920005553/en/ Watch free full-length feature film: trumpmovienow.com (Photo: Business Wire) “The Western Journal does great work and we are happy they are partnering with us,” stated Stephen K. Bannon. “It’s a film that every American, regardless of political belief, should watch. It’s a historic time for our country, and no one should be sitting on the sidelines during the upcoming elections.” Directed by Bannon and produced by Dan Fleuette, Trump @War is a retelling of the most significant election campaign in modern U.S. history and a look forward to the high-stakes midterm election in November 2018, which will cement President Trump’s legacy. “Steve Banno
GTIS Partners Grabs Top Spots in Prestigious GRESB Sustainability Ranking20.9.2018 14:24 | Pressemelding
GTIS Partners LP (“GTIS”), a real assets investment firm headquartered in New York City, with offices in São Paulo, Los Angeles, San Francisco, Atlanta, Paris and Munich, today announced that the GTIS Brazil Real Estate Fund (“GTIS Brazil Real Estate Fund I”) has been recognized as 2018’s most sustainable private equity real estate investment fund in South America by the Global Real Estate Sustainability Benchmark (GRESB). This is the fourth year running the fund has clinched the top ranking. GTIS Brazil Real Estate Funds II and III took second- and third-place honors, respectively, matching the funds’ 2017 survey rankings. “Our across-the-board top-place rankings are a testament to the day-in, day-out efforts of the entire GTIS Brazil team, who’ve incorporated environmental, social and governance principles into their investment and management practices,” said Josh Pristaw, Senior Managing Director, Head of Capital Markets and Co-head of Brazil at GTIS Partners. “What we’re most proud