Nasdaq GlobeNewswire

XBiotech Announces First Patient in Phase 2 Study Evaluating Subcutaneous MABp1 in Patients with Hidradenitis Suppurativa

Del

 

AUSTIN, Texas, July 10, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT) announced today that the first patient has been enrolled in its Phase 2 open label, dose escalation clinical study evaluating the Company's subcutaneous formulation of MABp1 in patients with moderate to severe Hidradenitis Suppurativa (HS). The patient began treatment at Tennessee Clinical Research Center located in Nashville under the care of Dr. Michael Gold.

Dr. Gold commented, "We are very excited to be participating with XBiotech in this ground breaking research endeavor for patients suffering from hidradenitis suppurativa.  We are hopeful that this research will unlock some of the important keys to successfully treating our patients."

XBiotech is developing a human-derived antibody (MABp1) which neutralizes IL-1 alpha (IL-1a), an inflammatory cytokine that plays a key role in the pathophysiology of a wide range of inflammatory skin disorders1. Three phase II studies sponsored by XBiotech have been completed in dermatologic indications (acne, psoriasis, pyoderma gangrenosum) 2,3. Results from an investigator sponsored phase 2 study evaluating MABp1 for the treatment of Hidradenitis Suppurativa were published in the Journal of Investigative Dermatology with the study meeting its primary endpoint, demonstrating significant improvement of HS patients treated with MABp1 compared to control after 12 weeks of therapy (response rate of 60% vs 10%, respectively (p=0.035)) 4,. This previous HS study, however, involved intravenous infusion of the antibody therapy.  This will be the first use of the MABp1 subcutaneous formulation in HS, including the use of pre-filled syringes with a newly developed concentrated formulation of MABp1 for convenient dosing.

For more information on this study, please visit www.clinicaltrials.gov

About Hidradenitis Suppurativa  
Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin disorder affecting areas rich in apocrine glands. Nodules appear in the affected areas and progressively become swollen with spontaneous rupture and release of pus. This process occurs repeatedly leading to formation of deep sinus tracts and painful dermal abscesses5,6. Therefore, HS is often devastating for patients with significant impact on quality of life 7. The Dermatology Quality Life Index (DQLI) for HS is 8.9, being higher than any other skin disorder8. Traditional treatments comprise of antibiotics, antiandrogens and surgery. The global prevalence for HS is estimated at up to 4% of the population 2.

About XBiotech
XBiotech is a fully integrated, global biopharmaceutical company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies. XBiotech currently is advancing a pipeline of therapies based on harnessing naturally occurring antibodies from patients with immunity to certain diseases. The approach to use natural human immunity as a source of new medicines offers the potential to redefine the standards of care a wide range of diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative manufacturing technology to reduce the cost and complexity of biological drug production. 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

1 Bou-Dargham MJ et al. The Role of Interleukin-1 in Inflammatory and Malignant Human Skin Diseases and the Rationale for Targeting Interleukin-1 Alpha. Med Res Rev. 2017 Jan;37(1):180-216.

2 Coleman KM et al. Open-Label Trial of MABp1, a True Human Monoclonal Antibody Targeting Interleukin 1a, for the Treatment of Psoriasis. JAMA Dermatol. 2015 May;151(5):555-6.

3 Carrasco D et al. An Open Label, Phase 2 Study of MABp1 Monotherapy for the Treatment of Acne Vulgaris and Psychiatric Comorbidity. J Drugs Dermatol. 2015 Jun;14(6):560-4.

4 Kanni T et al. MABp1 Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study. J Invest Dermatol. 2017 Nov 9.

5 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.

6 Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi: 10.1016/j.jaad.2008.11.911.

7 Vasquez BG, Alikhan A, Weaver, AL, et al. Incidence of hidradenitis suppurativa and associated factors: a population-based study of Olmsted County, Minnesota. J Invest Dermatol. 2013 Jan;133(1):97-103. doi: 10.1038/jid.2012.255. Epub 2012 Aug 30.

8 Révuz JE, Canoui-Poitrine F, Wolkenstein P, et al. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol 2008; 59: 695-701.




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: XBiotech, Inc via Globenewswire

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

Anomali Launches Comprehensive Threat Platform to Detect and Respond to Cyber Attacks20.9.2018 16:00Pressemelding

New Anomali Threat Platform delivers complete threat detection, analysis and response NATIONAL HARBOR, Md., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Anomali today announced at the Detect Conference 2018 the launch of the Anomali Threat Platform, a comprehensive threat detection and response suite. The Anomali Threat Platform represents the culmination of five years of ongoing innovation to provide organizations a unified solution to identify cyberthreats, understand the adversary, and automate response. The Anomali Threat Platform is comprised of five core capabilities, each addressing a specific need for threat mitigation, and all working together to deliver a complete security solution. Intelligence: collection, optimization and enrichment of threat intelligence Investigation: understand cyber threats with comprehensive analyst workbench Detection: proactive detection of active, serious threats targeting client networks Automation: eliminate manual processes and streamline investigation an

Anomali Announces Major Expansion of Threat Platform Partner Ecosystem20.9.2018 16:00Pressemelding

New Developer SDKs enable partners to integrate solutions with Anomali Threat Platform NATIONAL HARBOR, Md., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Anomali today announced at the Detect Conference 2018 the expansion of the partner ecosystem with the launch of a suite of partner developer resources. The new tools enable easier and faster integration with the Anomali Threat Platform and APP Store, allowing clients immediate access to partner content, integrations and analytics. The partner program expansion includes the launch of a suite of software development kits (SDKs). The SDKs address three critical integration areas: Threat Intelligence Feeds SDK: integrate proprietary threat intelligence feeds and make these accessible via the APP Store Integration SDK: integrate threat intelligence from the Anomali Threat Platform into third party products and solutions Enrichment SDK: integrate 3rd party threat analysis and data enrichments into the Anomali Threat Platform “Organizations need a com

Taconic Biosciences Becomes the First Animal Model Provider on Federal General Services Administration20.9.2018 15:40Pressemelding

RENSSELAER, N.Y., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered rodent model solutions, announces a new relationship with Government Scientific Source (GSS). GSS is a leading dedicated distributor of laboratory products and equipment to federal, state, and local governments. Most notably, GSS has direct procurement relationships with the federal General Services Administration (GSA). By having Taconic’s products available via GSS, they can now be accessed by all federal agencies, including but not limited to the National Institutes of Health and the Department of Defense. Taconic is the only animal model provider affiliated with GSS and also the only provider with a channel to the GSA. “An important component of providing customers with the best animal model solutions is access to key resources. Through this exciting new relationship with GSS, Taconic can now easily connect with scientists doing some of the most valuable res

Storms and Natural Disasters Create Millions in Recovery for Accounting Organizations20.9.2018 15:00Pressemelding

ATLANTA, Sept. 20, 2018 (GLOBE NEWSWIRE) -- As tropical storms and destructive forest fires attack the United States, companies and government organizations are in a rush to allocate dollars for the recovery of infrastructure. Meanwhile, strategic accounting teams prepare ahead of critical events by creating long-range asset plans, which include the repair and replacement of damaged infrastructure. The reason for the rush? This year is on track to have greater natural disaster recovery costs than last year. In 2017, the United States had a record-breaking year in damage caused by natural disasters, with the cumulative amount of damage totaling $306.2 billion, according to the National Oceanic and Atmospheric Administration. “As natural disasters and extraordinary events have become more common, organizations have realized the need to prepare financially to ensure the successful management of any resulting damage,” said Brent Burns, Chief Operating Officer of PowerPlan. “Pro-active orga

XBiotech Announces Addition of Top Dermatologist and Researcher Dr. Alice Gottlieb to its Team20.9.2018 14:00Pressemelding

AUSTIN, Texas, Sept. 20, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today the addition of Alice Gottlieb, M.D., Ph.D., to its Scientific Advisory Board (SAB). Dr. Alice Gottlieb is internationally recognized for her expertise and pioneering work in the development of biological therapies to treat skin diseases. Dr. Gottlieb has played key roles in the clinical evaluation of therapies such as etanercept, infliximab, ustekinumab and secukinumab. Dr. Gottlieb will work to help guide the clinical development of bermekimab, the Company’s candidate antibody therapy for skin diseases. Dr. Gottlieb is currently Professor of Dermatology at New York Medical College and former Chair of Dermatology and Dermatologist-in-Chief at the Tufts Medical Center and Tufts University School of Medicine. Dr. Gottlieb was elected to the Board of Directors of the American Academy of Dermatology from 2011-2015 and is the Founder and President of the Board of the International Dermatology Out

New Research Shows 63 Percent of Enterprises Are Adopting Microservices Architectures Yet 50 Percent Are Unaware of the Impact on Revenue-Generating Business Processes20.9.2018 14:00Pressemelding

Camunda Survey Reveals Digital Transformation Is Very Important to Virtually All Software Pros and More Than Half Say Digital Disruption is Accelerating Very Rapidly BERLIN and SAN FRANCISCO, Sept. 20, 2018 (GLOBE NEWSWIRE) -- As companies bring more business functions online through digital transformation initiatives, the adoption of microservices architectures is becoming mainstream, according to a survey of 354 enterprises conducted by Camunda. Sixty-three percent of companies surveyed are currently using microservices architectures, with “improved employee efficiency,” “improved customer/end-user experience,” and “cost savings on infrastructure and other development tools” as the top three business benefits cited. The global survey was conducted in July 2018 and represents the views of software architects, engineering managers and other experts in application development, across 51 countries and twelve industries. Despite the growing popularity of microservices, the survey reveals

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

Besøk vårt presserom