XBiotech Announces Completion of U.S. Enrollment in Phase 2 Multicenter Study Evaluating Bermekimab in Patients with Hidradenitis Suppurativa
AUSTIN, Texas, Sept. 24, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today that it had completed enrollment in the U.S. for its Phase 2, open label clinical study evaluating subcutaneous administration of bermekimab in patients with moderate to severe Hidradenitis Suppurativa (HS). Enrollment has exceeded the planned limit for the study in just over two months, significantly outpacing expectations. XBiotech plans to accept a limited number of additional patients in Europe prior to study completion.
John Simard, Chairman & CEO of XBiotech, commented, “We are very pleased by the enrollment rate we have seen in this study. Patient availability has been well beyond what was predicted. I believe this speaks to the need for new treatment options for this debilitating disease. I want to thank all of the patients and clinical sites for their ongoing participation in this study.”
The phase 2 study involves a 13-week treatment regimen. Two groups of patients are being treated with bermekimab: those who have had and failed prior anti-TNF therapy; and those with no prior anti-TNF treatment history. Bermekimab was previously evaluated for treatment of hidradenitis suppurativa in a double blind, placebo controlled study. In that study, 60% of treated patients achieved the primary efficacy endpoint, a positive HiSCR, versus only 10% of patients who had received placebo. Patients were treated with an intravenous formula of bermekimab. Based on feedback from key opinion leaders, XBiotech developed and is now evaluating a subcutaneous formulation in pre-filled syringes that can be conveniently administered.
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.
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