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xbiotech inc (XBIT) Details

XBiotech Inc., a pre-market biopharmaceutical company, engages in discovering and developing True Human monoclonal antibodies for treating various diseases. The company’s lead product is bermekimab, a therapeutic antibody that neutralizes interleukin-1 alpha, which has completed Phase III clinical trial in Europe for the treatment of symptomatic and advanced colorectal cancer. It has also investigating its lead product candidate in various clinical trials for other inflammatory conditions, including vascular disease, type II diabetes, acne, psoriasis, pyoderma gangrenosum, and hidradenitis suppurativa, as well as staphylococcus aureus infection and influenza diseases. XBiotech, Inc. was founded in 2005 and is headquartered in Austin, Texas.

56 Employees
Last Reported Date: 05/9/19
Founded in 2005

xbiotech inc (XBIT) Top Compensated Officers

Founder, President, CEO & Chairman
Total Annual Compensation: $787.0K
VP of Finance & Human Resources and Secretary
Total Annual Compensation: $199.0K
Chief Scientific Officer
Total Annual Compensation: $312.5K
Compensation as of Fiscal Year 2018.
xbiotech inc
XBiotech Announces Plan to Launch Randomized Phase 2b Study of Bermekimab in Hidradenitis Suppurativa

XBiotech announced plans to advance its dermatology program for its true human antibody bermekimab with the launch of a randomized, double-blind, placebo controlled, Phase 2b clinical study in patients with moderate to severe Hidradenitis Suppurativa (HS). This Phase 2b study will evaluate safety and efficacy of bermekimab at different subcutaneous doses compared with placebo. The study will further evaluate efficacy of bermekimab in HS and guide dosing strategies for the anticipated Phase 3 registration study. The Company expects the first patient to be enrolled during the third quarter of 2019. The Phase 2b study follows two previous successful clinical studies of bermekimab to treat HS. XBiotech recently evaluated bermekimab in a phase 2 study involving two groups of patients with HS: those who had no prior treatment with biologics; and those who had failed the only approved biological therapy to treat HS. The study, which was conducted at eleven research centers across the U.S. showed bermekimab was similarly effective in HS patients regardless of prior treatment with the current approved therapy. Results of the study demonstrated that weekly treatment with bermekimab was associated with statistically significant improvement in HS, as measured by the FDA-sanctioned Hidradenitis Suppurativa Clinical Response score (HiSCR). In the study, 61% of patients with no prior biological therapy achieved positive HiSCR at 12 weeks, while 63% of patients who had failed previous biological therapy also achieved a positive HiSCR. HS is associated with severe pain and thus pain was a key measure in the study. At the study’s endpoint, patients with no prior biological therapy had a 64% reduction in pain compared with baseline, while those who had previously failed anti-TNF therapy had a 54% reduction in pain (for the only approved therapy for HS (Humira), only 43% of patients achieved HiSCR in its Phase III study that did not allow antibiotics; and there was no significant reduction in pain for Humira treated patients in the Phase 3 study).

Xbiotech Inc. Reports Earnings Results for the First Quarter Ended March 31, 2019

XBiotech Inc. announced earnings results for the first quarter ended March 31, 2019. For the first quarter, the company announced operating loss was USD 5.805 million compared to USD 4.150 million a year ago. Net loss was USD 5.864 million compared to USD 4.069 million a year ago. Basic loss per share from continuing operations was USD 0.16 compared to USD 0.11 a year ago.

XBiotech Inc. Announces Enrollment Completion, Positive Findings for Bermekimab in Pancreatic Cancer Study

XBiotech Inc. announced enrollment of the final patient into its Phase I study1 evaluating bermekimab in patients with advanced pancreatic adenocarcinoma and cachexia. The study is being conducted and led by principal investigator Andrew Hendifar, M.D., Medical Oncology lead for the Gastrointestinal Disease Research Group and Co-Director of Pancreas Oncology at Cedars-Sinai Medical Center. A total of 18 patients are enrolled in the study. The purpose of the study is to assess the safety and tolerability of bermekimab in combination with chemotherapy. The study will also assess progression-free survival and overall survival of patients, as well as evaluate the relationship between treatment tolerance and patient functional status. Various health-related secondary measures, including changes in lean body mass, weight stability, and levels of systemic inflammation are also being assessed. Chemotherapy is being given intravenously with bermekimab every two weeks until disease progression. Extensive historical data on the pancreatic cancer population will be used to evaluate secondary endpoints in this study. The prognosis for advanced pancreatic cancer remains poor despite decades of studies. The 5-year survival has remained close to 5%, unchanged despite improvements in chemotherapeutics, surgical outcomes, and diagnostic techniques. Other than multi-agent cytotoxic therapy, there have been no treatment advances for pancreatic cancer or its associated cachexia. Bermekimab was found to improve clusters of symptoms and led to improvements such as reduced pain and fatigue, improved appetite, and increased lean body mass in advanced cancer patients. Patients who had these improvements were found to have less tumor progression, substantially reduced serious adverse events related to disease, and approximately a three-fold improvement in survival.

 

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