XBiotech Announces Enrollment Completion in Phase 2 Multicenter Study Evaluating Bermekimab in Patients with Atopic Dermatitis
AUSTIN, Texas, Oct. 05, 2018 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today that it has completed enrollment in its Phase 2, open label clinical study evaluating subcutaneous administration of bermekimab in patients with moderate to severe Atopic Dermatitis (AD). XBiotech has now completed and exceeded enrollment in the final cohort of patients who are receiving 400mg weekly doses of bermekimab over an 8 week treatment period. Enrollment for the study is now closed.
XBiotech recently announced it completed the first cohort of patients in the study who received a low dose of bermekimab (200mg/weekly) over a 4 week treatment regimen. The Company reported that patients in the first cohort had significant improvement in multiple efficacy endpoints and that the treatment was well-tolerated.
XBiotech’s Medical Director, Mark Williams, M.D., M.B.A., commented, “I am extremely encouraged by an enrollment rate that has exceeded expectations. We look forward to completing the treatment protocol for our patients and evaluating the results.”
The phase 2, open label, dose escalation, multicenter study consists of two dose cohorts of bermekimab in patients with moderate to severe AD. Dose ranging in the study includes evaluation of the Company’s new highly-concentrated subcutaneous formulation. Nine patients in the first dosing cohort received a total of 4 weekly 200mg subcutaneous injections of bermekimab followed by safety assessments. Patients in the second cohort will receive 8 weekly 400mg subcutaneous injections of bermekimab for assessment of safety and preliminary efficacy.
Dr. Williams is as a medical director at XBiotech. He received his undergraduate degree in Human Biology at Stanford University and completed medical school at Yale. He also earned an MBA from the Stanford Graduate School of Business and has been awarded fellowships from the California Heart Association, the National Science Foundation and the Rand Corporation. Dr. Williams has conducted research in cardiology, biochemistry, analytic chemistry and health policy, and is published in a number of peer-reviewed journals.
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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