Commences study to assess novel RORγt inhibitor for the treatment of psoriasis Recruits key opinion leaders to guide clinical development of its RORγt programs.
NIJMEGEN, The Netherlands and Encinitas, California, August 13, 2018 – Escalier Biosciences, BV, a privately held biopharmaceutical company and a leader in the field of immunology, today announced that the first patient has been dosed in a Phase 1/2a study evaluating ESR-114 topical gel in patients with mild-to-moderate psoriasis.
“The initiation of this study represents a significant milestone for Escalier as it validates our model of advancing high quality drug candidates from the bench to the clinic in less than two years,” said Raju Mohan, Ph.D., founder and Chief Executive Officer of Escalier. “We look forward to announcing top-line clinical results from the Phase 1/2a study of ESR-114 topical gel and progressing our lead oral RORγt inhibitor into the clinic in the first half of 2019. We will provide an update on our oral RORγt program in the fourth quarter of 2018.”
“We are pleased to also announce our Clinical Advisory Board,” continued Raju Mohan. “They are all leading experts in their field and the broad range of experience and expertise that they bring in autoimmune diseases will be invaluable as we develop ESR-114 topical gel and other RORγt inhibitors.”
Members of the Escalier Clinical Advisory Board include:
James G. Krueger, M.D., Ph.D.
Dr. Krueger is Head of the Laboratory for Investigative Dermatology at the Rockefeller University where he also serves as a physician, co-director of the Center for Clinical and Translational Science and the Chief Executive Officer of the Rockefeller University Hospital in New York City.
Emma Guttman-Yassky, M.D., Ph.D.
Dr. Guttman-Yassky is a Professor of Dermatology and Immunology and Vice Chair, Department of Dermatology at the Icahn School of Medicine at Mount Sinai in NY. She is also the Director of the Center for Excellence in Eczema and the Laboratory for Inflammatory Skin Diseases.
Alexa Kimball, M.D., M.P.H.
Dr. Kimball is the Medical Director of the Massachusetts General Physician Organization and a Professor of Dermatology at Harvard Medical School. She is also the Director of the Clinical Unit for Research Trials and Outcomes in Skin based at the Massachusetts General Hospital in Boston.
Willam Sandborn, M.D.
Dr. Sandborn is a Professor in the Department of Medicine at the University of California San Diego School of Medicine (UCSD) and the Chief of the Division of Gastroenterology, Vice Chair of Clinical Operations. He also directs the Inflammatory Bowel Disease Center at UCSD.
Sander van Deventer, M.D., Ph.D.
Dr. van Deventer is an Operating Partner at Forbion Capital partners and a Professor of Translational Gastroenterology at Leiden University Medical Center. He is also the General Manager and Chief Scientific Officer of uniQure in Amsterdam.
About the Phase 1/2a Study with ESR-114
The study is designed to evaluate the safety, tolerability, dose-response and pharmacokinetics of two concentrations of ESR-114 topical gel compared with its vehicle (placebo). Over 110 subjects with mild to moderate psoriasis will be randomized into this double-blind, placebo-controlled trial across 10 centers in the United States and Canada.
About ESR-114 Topical Gel
ESR-114 topical gel is a selective, potent inhibitor of RORγt designed to have its pharmacological activity targeted to the skin with minimal systemic absorption. Inhibition of RORγt has been shown to reduce production of the inflammatory cytokine IL-17, which plays a key role in psoriasis and other autoimmune disorders. ESR-114 topical gel is currently being evaluated to determine if it may reduce or treat the clinical manifestations of psoriasis.
Psoriasis is a chronic, autoimmune disease that results in raised, red, scaly patches on the skin. It is estimated that 7.5 million Americans and 125 million people worldwide have psoriasis. Between 10-30% of people with psoriasis also develop psoriatic arthritis. Patients are categorized into mild, moderate or severe with the National Psoriasis Foundation. The majority of psoriasis patients are in the mild to moderate category.
Escalier Biosciences, BV is a privately held biopharmaceutical company developing novel small molecule therapeutics that target RORyt for the treatment of psoriasis and other autoimmune disorders. Escalier is registered in The Netherlands with offices in Nijmegen, The Netherlands and Encinitas, California. www.escalierbio.com.
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