Breakthrough Results from Phase 2 Clinical Trial of Bermekimab in the Treatment of Atopic Dermatitis (AD) to be Presented on March 2, 2019 at American Academy of Dermatology Annual Meeting
Rapid and significant reduction in skin lesions, 66% (p<0.001) and 76% (p<0.001) mean reduction in EASI score in 4 and 7 weeks, respectively.
Rapid and significant resolution of worst itch and pain, 57% (p<0.001) and 61% (p<0.001) mean reduction within 4 weeks, respectively.
- Substantial mean reduction of worst itch and pain 71% (p<0.001) and 84% (p<0.001) within 7 weeks, respectively.
AUSTIN, Texas, March 01, 2019 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ: XBIT) announced today that breakthrough results from its Phase 2 clinical trial of its antibody therapy, bermekimab, are being presented tomorrow at a late-breaking oral presentation during the annual meeting of the American Academy of Dermatology (AAD) being held in Washington, DC. The presentation titled, “Bermekimab is a Rapid and Effective Treatment for Atopic Dermatitis (AD)” will take place on Saturday, March 2 at 1:10pmET in Ballroom A and will be presented by international dermatology expert, and lead researcher in the development of approved therapies for atopic dermatitis, Eric Simpson, M.D, M.C.R. Professor of Dermatology at Oregon Health & Science University, School of Medicine.
The results being presented by Dr. Simpson demonstrate that bermekimab treatment resulted in rapid and significant improvement of disease in patients with moderate-to-severe AD. After only 7 weeks of treatment, 71% of patients that received a 400mg bermekimab weekly regimen had at least 75% reduction in their disease, as measured by the Eczema Area and Severity Index (EASI) score (this compares to 44-51% of patients achieving 75% improvement in EASI score after 16 weeks therapy as reported for two Phase III clinical trials for the existing FDA approved biological drug for AD). Moreover, within 7 weeks, using patient reported Numerical Rating Scale (NRS) for itch and pain, patients receiving the 400mg bermekimab treatment regimen had 71% reduction in itch and an 84% reduction in pain (this compares to 36-41% reduction in itch [pain was not reported] after 16 weeks of treatment with the existing approved therapy for AD).
XBiotech CEO John Simard commented, “We are thrilled to have Dr. Simpson present these findings at the AAD tomorrow. We expect these results to enable the advancement of a new and very important treatment for what is a rather under appreciated disease in terms of its severity and wide-spread impact on the lives of people around the world.”
In the study, 38 patients in two treatment groups received a low (200mg) or high (400mg) dose of bermekimab once weekly for either a 4 or 7-week treatment regimen, respectively. There was statistically and clinically significant improvement in treatment response for key measures of disease severity in the high dose versus the low dose group.
About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
One Liberty Plaza - 165 Broadway
NY 10006 New York
GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
Følg saker fra GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra GlobeNewswire
Tricentis Disrupts RPA Market with Resilient Model-Based Automation22.5.2019 17:00:00 CEST | Pressemelding
Model-based automation technology trusted by 1600+ enterprise organizations now drives a dedicated Tricentis RPA offering MOUNTAIN VIEW, Calif., May 22, 2019 (GLOBE NEWSWIRE) -- Tricentis today announced the availability of Tricentis RPA, which is differentiated by its award-winning model-based automation technology and radically simplified bot pricing model. Tricentis’ model-based automation technology has over 12 years of research and development behind it, and is currently leveraged by 1600+ enterprise organizations. It is best known for delivering highly-resilient end-to-end automation of complex business processes—supporting over 150 enterprise technologies, from legacy applications to the most modern SaaS-based apps. “To satisfy rapidly-changing customer expectations, organizations must be able to change existing processes and applications with both agility and confidence,” explained Tricentis Founder and Chief Strategy Officer Wolfgang Platz. “They need to know that the automati
LGC Capital announces that it has increased its ownership to 40.4% of Little Green Pharma in Australia22.5.2019 16:25:00 CEST | Pressemelding
MONTRÉAL, May 22, 2019 (GLOBE NEWSWIRE) -- LGC Capital Ltd. (TSXV: LG) (OTCQB: LGGCF) ("LGC" or the “Corporation”) announces that after much negotiation, it has successfully acquired, from a non-executive founder, additional shares in Australia’s licensed medical cannabis producer Little Green Pharma (LGP) bringing its ownership from 14.1% up to 40.4%. LGP was the first, and is currently the only, domestic cannabis company in Australia producing a locally grown medicinal cannabis medicine for patients. LGC believes the opportunity to increase its ownership in LGP creates significant value for its shareholders and enables the Corporation to further take part in the rapidly expanding Australian medical cannabis market. Little Green Pharma has had over 400 patients approved in Australia, with new patients increasing exponentially month-over-month. The Australian industry represents one of the fastest growing international medical cannabis markets globally, with approximately 6,400 SAS B f
Virtusa recognized as a Visionary in the Magic Quadrant for CRM and Customer Experience Implementation Services, Worldwide22.5.2019 16:05:00 CEST | Pressemelding
SOUTHBOROUGH, Mass., May 22, 2019 (GLOBE NEWSWIRE) -- Virtusa Corporation (NASDAQ GS:VRTU), a global provider of digital strategy, digital engineering, and IT outsourcing services that accelerates business outcomes for its clients, today announced that Gartner, Inc. has positioned Virtusa in the Visionaries Quadrant of the 2019 Magic Quadrant for CRM and Customer Experience (CX) Implementation Services, Worldwide. The report evaluated Virtusa along with 17 other companies in CRM and Customer Experience Implementation Services. Virtusa was one of only three companies to be categorized as a Visionary. According to Gartner, “The CX and CRM implementation service market is completing the shift from the implementation of core CRM technology to complex initiatives that not only transform the front office but integrate across the full enterprise’s operations. Customers now demand that organizations provide them with a continuous experience, preserving continuity of user experience across trad
InnovMetric Launches PolyWorks® Metrology Suite 201922.5.2019 15:00:00 CEST | Pressemelding
Facilitates Deployment of PolyWorks|Inspector™ in Production and Accelerates CNC CMM Measurement Sequences QUEBEC CITY, May 22, 2019 (GLOBE NEWSWIRE) -- InnovMetric Software Inc., the leading provider of universal 3D metrology software solutions, today announced the launch of the 2019 release of the PolyWorks Metrology Suite. This latest major release delivers new object measurement scripts that open the door to all the custom measurement techniques of clients within the standard PolyWorks workflow, as well as a new assisted sequencing approach that promises to greatly accelerate the time to set up CMM sequences. “Simplifying the lives of our customers while keeping them fully in control. This statement embodies the development philosophy behind the PolyWorks Metrology Suite and the latest 2019 release,” said Marc Soucy, President of InnovMetric. He added, “With its outstanding innovations that combine increased simplicity with important time savings, we are proud to bring the producti
Brookfield Asset Management Announces Renewal of Normal Course Issuer Bid22.5.2019 12:55:00 CEST | Pressemelding
BROOKFIELD, May 22, 2019 (GLOBE NEWSWIRE) -- Brookfield Asset Management Inc. (NYSE: BAM) (TSX: BAM.A) (EURONEXT: BAMA) (“Brookfield”) today announced it has received approval from the Toronto Stock Exchange (“TSX”) for the renewal of its normal course issuer bid to purchase up to 82,530,440 Class A Limited Voting Shares (“Class A Shares”), representing 10% of the public float of Brookfield’s outstanding Class A Shares. Purchases under the bid will be made through the facilities of the TSX, the New York Stock Exchange (“NYSE”), and/or alternative trading systems. The period of the normal course issuer bid will extend from May 24, 2019 to May 23, 2020, or an earlier date should Brookfield complete its purchases. Brookfield will pay the market price at the time of acquisition for any Class A Shares purchased or such other price as may be permitted. As at May 17, 2019, the number of Class A Shares issued and outstanding totalled 994,568,660, of which 825,304,404 shares represented the pub
Phenom People Launches University Recruiting, SMS & Internal Mobility Chatbot22.5.2019 10:00:00 CEST | Pressemelding
Product Innovations to Support Demand for Talent Experience Management LONDON, May 22, 2019 (GLOBE NEWSWIRE) -- Phenom People, the global leader in Talent Experience Management (TXM), has announced several new features for the Phenom Talent Experience Management platform, adding University Recruiting, SMS, WhatsApp messaging and Internal Mobility chatbot functionality to further support the demands of the new talent economy, which is undergoing major technological and societal shifts. The Phenom Talent Experience Management platform connects the interactions of the four key experiences in the talent lifecycle: candidates, recruiters, employees and management, and delivers a single platform to unify them. Cross-functional insights can be used to power a more personalised and effective experience that meets the demands of today’s talent. The Phenom Talent Experience Management platform furthers chief human resources officers’ top responsibilities across talent acquisition, talent managem