DUBLIN, Ireland, July 30, 2018 (GLOBE NEWSWIRE) — Sublimity Therapeutics, a specialty pharmaceutical company focused on the treatment of ulcerative colitis, today announced the appointment of industry veteran Jesse W. Hall, M.D., as Chief Medical Officer.
Dr. Hall has more than 14 years of experience leading medical affairs and drug development activities for major pharma and innovative biotech companies with portfolios encompassing both small and large molecules.
“Jesse is an accomplished biopharmaceutical executive with a proven track record in drug development resulting in successful submissions across the globe,” said Sublimity Therapeutics’ Chief Executive Officer and Biologist, Albert Agro, Ph.D. “He will play a pivotal role in shaping Sublimity’s future as our lead pipeline product for the treatment of ulcerative colitis, STI-0529, moves into the next phase of clinical development.”
STI-0529 (formerly “CyCol®”) is a cyclosporine-based therapy administered via Sublimity’s proprietary, advanced oral drug delivery technology platform. It allows for optimized local, topical treatment of gastrointestinal diseases while minimizing systemic absorption.
Dr. Hall said, “It’s an exciting time to lead Sublimity’s global drug development program. More than 900,000 people suffer from ulcerative colitis in the U.S. I look forward to advancing the development of STI-0529 to address the significant unmet needs of patients looking for a safer, more tolerable alternative to current treatments.”
Dr. Hall started his career at Abbott Laboratories working in the immunology franchise assigned to Humira (adalimumab) and leading the US rheumatology medical affairs team. After leaving Abbott, Dr. Hall joined Amgen as a medical director working to launch the first monoclonal antibody, Prolia (denosumab), in primary care, for osteoporosis. He next joined Ardea Biosciences, a San Diego-based biotechnology company, as an executive medical director, leading both the early development program as well as a global phase 2 development program.
Dr. Hall received his medical degree from the University of Oklahoma and a Bachelor of Arts from the University of San Diego. He conducted his surgical training at Hahnemann University in Philadelphia, Pennsylvania.
About Ulcerative Colitis
It is estimated that ulcerative colitis affects approximately 1.4 million patients in North America, Europe and other developed countries. The moderate to severe patient segment represents the fastest growing market segment, with double-digit annual growth. The mainstays of treatment for this disease are anti-TNFs; however, these drugs are limited by their toxicities and safety liabilities. A large portion of patients are either unresponsive to initial front-line anti-TNF therapy or become refractory to treatment within the first year. Despite the introduction of new medicines, these patients still have significant unmet medical needs.
About Sublimity Therapeutics
Sublimity Therapeutics is a specialty pharma company with offices in Dublin, Ireland, and Solana Beach, California. Sublimity’s goal is to identify and create meaningful new therapies for unmet clinical needs in gastrointestinal and immunological diseases. Sublimity’s priority focus is on its lead product, STI-0529, for treatment of moderate to severe ulcerative colitis. Sublimity has a strategic collaboration with Dr. Falk Pharma GmBH that includes development funding, milestone payments and tiered double-digit royalties for the future development and commercialization of STI-0529 and related products in Europe. In May 2018, Sublimity announced a US$64 million financing to further the development of STI-0529, including a global Phase 2b dose-ranging study designed to evaluate the safety and efficacy of STI-0529. The financing was co-led by OrbiMed and Longitude Capital with participation from HBM Healthcare Investments.
About Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH is one of the leading companies worldwide in gastroenterology with its products being sold in more than 60 countries. Its pharmaceuticals are used successfully to treat inflammatory bowel disease, cholestatic liver disease, irritable bowel syndrome, constipation, and for colon cleansing prior to colonoscopies. The Falk Foundation, which is associated with the company, provides medical information via international symposia, forums, postgraduate courses and literature services. Over the past 45 years the Falk Foundation has sponsored more than 200 international Falk symposia and workshops in which over 100,000 researchers and physicians from 110 countries have come together to advance knowledge in gastroenterology and hepatology.
This press release contains forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties. We have tried, wherever possible, to identify such statements by using words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “forecast,” “goal,” “objective,” “aim” and other words and terms of similar meaning or by using future dates in connection with any discussion thereof. In particular, statements, express or implied, concerning future actions, conditions or events, future operating results, the potential medical benefits of STI-0529, the perceived potential opportunity in the ulcerative colitis market for an oral alternative, the intended completion of the Phase 2b study and the success of future clinical trials, the ability to obtain required regulatory approval for STI-0529, the ability to generate income or cash flow from STI-0529, are forward-looking statements. We cannot guarantee that any forward-looking statement will be realized, although we believe we have been prudent in our plans and assumptions. Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions. Should known or unknown risks or uncertainties materialize, or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. You should bear this in mind as you consider forward-looking statements, and you are cautioned not to put undue reliance on forward-looking statements. Sublimity undertakes no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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