Nasdaq GlobeNewswire

XBiotech Announces Completion and Positive Interim Findings for Initial Cohort in Bermekimab Pilot Study in Atopic Dermatitis

Del

Company Reports Positive Safety Outcome and Statistically Significant Improvements in Atopic Dermatitis Patients Treated with Low Dose, Short Course of Bermekimab

AUSTIN, Texas, Sept. 13, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced that it has completed the first cohort of its open label pilot study in Atopic Dermatitis (AD).  In the first phase of the study, 9 patients received a low dose (200mg/weekly) over a short course of treatment (4 weeks). Multiple secondary endpoints used to assess efficacy showed significant improvements. The 200mg subcutaneous injections were well tolerated in the cohort. The study will now begin enrollment of 20 patients to receive 400mg weekly doses over an 8 week treatment period.

The Study Chair, Dr. Francisco Kerdel, commented, “Although this is a small sample, I am encouraged by the benefit observed in AD patients treated with bermekimab.  I look forward to the results from the second cohort in patients who will receive a higher dose and longer treatment duration with bermekimab.”

Bermekimab treatment was associated with the following statistically significant outcomes for assessment of atopic dermatitis severity and response:

  • Eczema Area and Severity Index score (EASI) improved by at least 50% for one third of the patients from baseline to week 4 [p=0.02, Wilcoxon Signed-Rank Test (WSRT)].
  • Dermatology Life Quality Index (DLQI), a questionnaire used to measure the impact of skin disease on the quality of life, showed a mean improvement of 57% (four out of nine patients showing at least a 75% improvement from baseline to week 4 of study, p=0.004, WSRT).
  • The SCORAD, a clinical tool for assessing extent and intensity of atopic dermatitis, showed a mean improvement of 25% for the cohort after 4 weeks.
  • The Pruritus Numerical Rating Scale (NRS), a patient-reported measure to assess itch intensity, decreased by more than 50% in one third of patients between baseline and Week 4 (p=0.04, WSRT). 
  • The Patient Oriented Eczema Measure (POEM), used to assess atopic dermatitis severity from the patient’s perspective, showed that seven out of nine patients reported more than 33% improvement from baseline to week 4 (p=0.004, WSRT).
  • The Hospital Anxiety and Depression Scale (HADS) was used to measure patient symptoms of anxiety and depression during the study.  Anxiety scores were reduced by at least half in 44% of patients.  In addition, two thirds of patients improved their depression scores by at least 66% (Anxiety and depression scores, p=0.0078 and p=0.03, respectively, WSRT).

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.

About XBiotech
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.

Contact
Ashley Otero
aotero@xbiotech.com
512-386-2930

Om Nasdaq GlobeNewswire

Nasdaq GlobeNewswire
Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra Nasdaq GlobeNewswire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Nasdaq GlobeNewswire

Bombardier Will Fully Cooperate with the AMF Review16.11.2018 00:06Pressemelding

MONTRÉAL, Nov. 15, 2018 (GLOBE NEWSWIRE) -- Bombardier acknowledges the announcement by the Autorité des marchés financiers (AMF) that it is reviewing the operations surrounding the establishment by Bombardier of an Automatic Securities Disposition Plan (ASDP) in August 2018 and various subsequent announcements. The ASDP had been reviewed by the AMF prior to its establishment on August 15, 2018. Bombardier intends to fully cooperate with the AMF in its review. The Company has taken the necessary measures to suspend all sales of securities pursuant to the ASDP until further notice. About Bombardier With over 69,500 employees across four business segments, Bombardier is a global leader in the transportation industry, creating innovative and game-changing planes and trains. Our products and services provide world-class transportation experiences that set new standards in passenger comfort, energy efficiency, reliability and safety. Headquartered in Montreal, Canada, Bombardier has product

ERYTECH Partners with New York Blood Center for Red Blood Cell Supply and Research15.11.2018 22:05Pressemelding

LYON, France and CAMBRIDGE, Mass., Nov. 15, 2018 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, today announced a strategic partnership with New York Blood Center (NYBC) for red blood cell supply and research. The partnership encompasses NYBC becoming a long-term supplier of donor red blood cells (RBC) to ERYTECH, enabling ERYTECH to diversify and broaden its supply of RBC source materials for the production of eryaspase and future product candidates derived from its proprietary ERYCAPS® platform as the company ramps up clinical development. Specifically for the Phase 3 trial in second-line metastatic pancreatic cancer that recently started enrolling patients in Europe, and the Phase 2 trial in first-line triple negative breast cancer (TNBC), which are both expected to begin enrollment in the United States early in 2019. The partnershi

Zageno Deepens Engagement with Scientists and Vendors through Its Meaningful and Unbiased Rating System for Scientific Products — Scientific Score gets Algorithm Update15.11.2018 15:37Pressemelding

Call for Contributions: Zageno’s rating system for scientific products — the Scientific Score — adds a crucial dimension to help research scientists purchase the right material for their experiment. Scientists: share your experimental data and professional experience about products; Life Science Vendors: provide additional product-specific resources and data points to make your products reach the right scientist CAMBRIDGE, Mass. USA and BERLIN, Germany, Nov. 15, 2018 (GLOBE NEWSWIRE) -- Zageno Inc., the largest and fastest-growing online marketplace for research materials, today issues an open call for scientists and vendors alike to contribute to the continuous improvement of the Scientific Score. Designed as an unbiased indicator to help purchasing scientists navigate the enormous amount of product information, the Scientific Score is the result of proprietary algorithms calculating and weighing different data points across multiple information formats. Among others, factors like rec

Motiv Ring Expands International Footprint and Delivers Industry-First Sizing Process15.11.2018 15:00Pressemelding

The wearable ring lands in 20 new countries and eight new stores, and introduces frictionless sizing method SAN FRANCISCO, Nov. 15, 2018 (GLOBE NEWSWIRE) -- Motiv Inc., creators of breakthrough wearable technology, today announced an increase of its product availability through new international availability and a new digital sizing set alternative. Motiv Ring’s international expansion will be through its website MyMotiv.com. Featured countries include: North America (Canada), Europe (Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Lithuania, Latvia, Netherlands, Poland, Portugal, Spain, Sweden, United Kingdom, Norway and Switzerland), as well as Japan, Taiwan, Turkey, Australia and New Zealand. Good fit is imperative to great functionality. To date, Motiv Ring users select their sizes after receiving a physical sizing kit in the mail. Releasing in Open Beta , Motiv Ring users will now have the additional option of determining their Motiv size via a

SignalFx Delivers Next Generation of Application Performance Monitoring15.11.2018 15:00Pressemelding

The first to enable directed troubleshooting for applications and microservices SAN MATEO, Calif., Nov. 15, 2018 (GLOBE NEWSWIRE) -- SignalFx, the leader in real-time cloud monitoring for infrastructure, microservices, and applications, today unveiled SignalFx Microservices APM™, the industry’s first real-time application performance monitoring solution designed to accelerate troubleshooting for DevOps teams through advanced real-time analytics. Powered by NoSample™ distributed tracing architecture, SignalFx Microservices APM observes every single transaction – not just a small random sample – and reports on every anomaly. With the new Outlier Analyzer™, the most challenging issues can now be pinpointed and resolved with a single click. SignalFx Microservices APM is built on top of SignalFx’s advanced streaming analytics platform for metrics which applies unsurpassed data science in real-time to identify the root cause of critical application problems. Integration with advanced automat

Minerva Neurosciences to Host Roluperidone Update and Key Opinion Leader Discussion of Negative Symptoms in CNS/Psychiatric Diseases on November 20, 201815.11.2018 14:30Pressemelding

Minerva management to provide update on Phase 3 clinical trial with roluperidone and single-dose escalation study findings Additional topics to include review of recent BDNF data with roluperidone and KOL discussion of trans-diagnostic approach to treating negative symptoms in CNS/psychiatry diseases WALTHAM, Mass., Nov. 15, 2018 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will host a roluperidone update and key opinion leader event on Tuesday, November 20, 2018 beginning at 8:00 a.m. Eastern Time in New York. Members of Minerva’s senior management will be joined by an expert key opinion leader. Discussions will feature the following speakers and topics: Gregory P. Strauss, Ph.D., Assistant Professor; Director: Clinical Affective Neuroscience Laboratory; Director: Georgia Psychiatric Risk Evaluation Program; Depa

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom