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 GlobeNewswire

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

https://globenewswire.com

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

Bio-Fence announces a breakthrough in Food Safety18.1.2019 08:11Pressemelding

The company have successfully completed a field trial of its new anti-microbial coating technology. The trials demonstrated a significant reduction in bacterial contamination during sensitive food production processes ASHDOD, Israel, Jan. 18, 2019 (GLOBE NEWSWIRE) -- Bio-Fence innovating coating technology announced today the successful completion of an intensive field trial on its innovative anti-microbial technology Pentagon. The trial was held in "Milouoff" (http://www.milouoff.co.il), one of the largest Ready to Eat poultry production sites in Israel and demonstrated superior results for Bio-Fence technology compared to alternatives. According to Mrs. Shiran Davidi, QA manager at Milouoff: “Bio-Fence technology seems to have clear benefits over existing antimicrobial solution. It is safe, highly potent and rechargeable.” The trial involved monitoring the performance of an epoxy floor coated with Bio-Fence anti-microbial technology compared to either commercial Silver Ion coating an

ERYTECH Presents TRYbeCA-1 Trial-in-Progress Poster at the 2019 ASCO GI Annual Meeting18.1.2019 07:00Pressemelding

LYON, France and CAMBRIDGE, Mass., Jan. 18, 2019 (GLOBE NEWSWIRE) -- ERYTECH Pharma (Euronext Paris: ERYP - Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, announced that a poster entitled “TRYbeCA-1: A randomized, phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with pancreatic adenocarcinoma (NCT03665441)” will be presented today at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in San Francisco. The poster (Abstract # TPS471) will be available at www.erytech.com after presentation at the conference. In September 2018, the TRYbeCA-1 trial was initiated. The Trial-in-Progress poster will provide an update on the study progress with investigators sites that have been initiated in multiple countries and actively recruiting patients. The trial is planned to enroll approximately 500 patients with

Fossil Group Enters Agreement To Sell Select Smartwatch Technology To Google17.1.2019 18:30Pressemelding

Transaction Unlocks Growth Opportunities for Fossil Group’s Wearables Business RICHARDSON, Texas, Jan. 17, 2019 (GLOBE NEWSWIRE) -- Today, Fossil Group (NASDAQ:FOSL) announced its plan to sell to Google for $40 million intellectual property (IP) related to a smartwatch technology currently under development by Fossil Group. As part of the transaction, a portion of Fossil Group’s research and development (R&D) team currently supporting the transferring IP will join Google. Fossil Group retains more than 200 R&D team members to focus on innovation and product development. The transaction showcases Fossil Group and Google’s shared investment in the wearables industry. In recent years, smartwatches have become Fossil Group’s fastest growing category. The company successfully developed and launched smartwatches across 14 of its owned and licensed brands. “Fossil Group has experienced significant success in its wearables business by focusing on product design and development informed by our

Calgon Carbon Corporation Announces Global Price Increase17.1.2019 17:16Pressemelding

Pittsburgh, PA, Jan. 17, 2019 (GLOBE NEWSWIRE) -- Calgon Carbon Corporation today announced a global price increase, effective February 1, 2019, where contracts permit, on all activated carbon products and related equipment due to a continued escalation in raw material costs and transportation expenses. The increase is expected to range between 10-15%, depending on the specific product, raw material type, services provided, and global market dynamics. The primary raw materials used for producing activated carbon are coal, coconut shell, and wood, each of which has gone up in price. Additionally, costs associated with both operating manufacturing facilities and transporting materials have also escalated. “Calgon Carbon’s raw material costs have increased significantly. Despite every effort to offset these increases through continuous improvements, the recent rise in raw material costs has exceeded our efforts,” said Jim Coccagno, Chief Commercial Officer for Calgon Carbon Corporation. “

Taconic Biosciences’ Animals Complete Most Recent Mission to the International Space Station17.1.2019 15:29Pressemelding

RENSSELAER, N.Y., Jan. 17, 2019 (GLOBE NEWSWIRE) -- Taconic Biosciences, a global leader in providing genetically engineered rodent model solutions, announces the completion of a recent mission to the International Space Station. This project represents a collaboration between the International Space Station (ISS) National Lab, National Aeronautics and Space Administration (NASA), Bioserve Space Technologies with support from the Leidos Corporation, and Taconic. Taconic has participated in several spaceflight missions with NASA since 1985. Most recently, as part of the science and research investigation payloads supported by the SpaceX Commercial Resupply Services missions, Taconic prepared mice to live aboard the International Space Station for extended periods. Previous spaceflight studies demonstrated that mice undergo rapid loss of muscle and bone mass, resembling accelerated aging. Therefore, mice exposed to microgravity via spaceflight are a valuable model to understand and devel

MPP Global Bridges the Innovation Gap by Centralising Physical and Digital Subscriber Management and Billing in a Single Cloud Platform17.1.2019 12:29Pressemelding

WARRINGTON, UK, Jan. 17, 2019 (GLOBE NEWSWIRE) -- MPP Global, the technology company that delivers eSuite, the world’s smartest subscriber management & billing platform, announces the launch of pivotal new functionality which enables media organisations to seamlessly create and manage the sale of physical subscriptions. This positions eSuite as the complete physical and digital subscription management solution. The development of this industry-first functionality was borne out of the common challenge for publishers when managing multiple systems for deploying bundled print and digital subscriptions. This is inflexible for publishers and limits choice for their customers, restricting the ability to seamlessly create and offer digital and print subscription bundles. Despite increased consumer uptake of digital subscriptions, print still accounts for almost 90% of circulation revenues globally. To drive reader revenues successfully, publishers require functionality to execute complementar