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XBiotech Announces Dr. Alice Gottlieb to Chair Upcoming Phase 2 Study of Bermekimab in Hidradenitis Suppurativa

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AUSTIN, Texas, June 25, 2019 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ: XBIT) announces that Alice Gottlieb M.D., Ph.D., will Chair the Company’s upcoming Phase II study in Hidradenitis Suppurativa (HS). Dr. Gottlieb is Medical Director of dermatology at the Mount Sinai Beth Israel Campus, and Clinical Professor at the Icahn School of Medicine at Mount Sinai. She is one of few doctors in the nation board certified in Dermatology, Rheumatology and Internal Medicine. This will be the second study Chaired by Dr. Gottlieb involving bermekimab in HS and the third study conducted for the drug in HS.

Dr. Gottlieb received an M.D.-Ph.D. from The Rockefeller University-Cornell University Medical College. Dr. Gottlieb founded the Tufts Dermatology residency program (which formally was shared with Boston University) and served as Chair of Dermatology and Dermatologist-in-Chief of Tufts Medical Center. She also founded the Dermatology Division at UMDNJ-Robert Wood Johnson Medical School where she served as Professor of Medicine, Director of the Clinical Research Center and Founding Director of the Psoriasis Center of Excellence. Before joining the Mount Sinai faculty, she was a Professor of Dermatology at New York Medical College. She is the founder and President of the International Dermatology Outcome Measures (IDEOM) group. Founded in 2013, this 501c3 non-profit, consortium of patients, physicians, pharmaceutical scientists and other stakeholders is dedicated to bringing outcome measures to dermatologic clinical research and practice that satisfy the needs of all stakeholders.

Dr. Gottlieb is internationally recognized for her pioneering work using targeted biological therapies, which helped lead the way for FDA-approvals. Dr. Gottlieb has authored over 400 manuscripts in leading scientific journals, such as The Lancet and The New England Journal of Medicine and has presented her groundbreaking research at hundreds of dermatology and rheumatology conferences around the world. On June 7, 2018 she was honored by an award from the National Psoriasis Foundation for her leadership in psoriasis and psoriatic arthritis research and care.

Dr. Gottlieb commented, “We need more effective treatments for hidradenitis suppurativa. Bermekimab offers the potential option for a more effective treatment for HS.”

XBiotech’s President & CEO, John Simard, commented, “We are honored to have Dr. Gottlieb continue to advance our bermekimab program in HS.”

Dr. Gottlieb chaired a recent open label study with bermekimab that demonstrated that weekly treatment with bermekimab was associated with statistically significant improvement in HS, as measured by the 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.

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 abscesses. Pain is a paramount condition in patients suffering from HS, as this chronic inflammation and accompanying pain account for the fact that HS is ranked first among skin disorders in terms of adversely affecting quality of life. The global prevalence of HS is estimated at up to 4% of the population.

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.

About XBiotech
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.

Contact
Ashley Otero
aotero@xbiotech.com
512-386-2930

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