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