Dr. Alice Gottlieb to Chair Phase II Bermekimab Study for Hidradenitis Suppurativa Patients

Jun 25, 2019 | Dermatology, Gottlieb, Alice MD Content, Hidradenitis Suppurativa, Investigator Content, XBiotech

TrialSite News has reported extensively about XBiotech’s quest to cure Hidradenitis suppurative. Our readers struggling with Hidradenitis suppurativa will be happy to know that Alice Gottlieb, MD, Ph.D., will chair the company’s upcoming Phase II bermekimab clinical trial.

Dr. Alice Gottlieb received an MD and PhD from the Rockefeller University—Cornell University Medical College. She is the Medical Director of Dermatology at the Mount Sinai Beth Israel Campus, and Clinical Professor at the Icahn School of Medicine at Mount Sinai. One of a few physicians in the nation board-certified in dermatology, rheumatology and internal medicine. This will be the second study Chaired by Dr. Gottlieb involving bermekimab in Hidradenitis suppurativa and the third study conducted for the drug on this difficult condition.

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 the 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 the quality of life. The global prevalence of HS is estimated at up to 4% of the population. 

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