On January 12th, 2022 Epics Therapeutics S.A., a private drug development company, reported the initiation of a First-in-Human, double-blind, placebo-controlled, single and multiple ascending dose study of EP282 to evaluate oral pharmacokinetics, pharmacodynamics, safety and tolerability in healthy male volunteers (Press release, EPICS Therapeutics, JAN 12, 2022, View Source [SID1234628628]). Specific biomarkers will also be monitored to evaluate drug-target engagement at different dose levels. Successful completion of this Phase I study will enable the initiation of Proof-of-Concept Phase II studies of EP282 in patient suffering from gastrointestinal inflammatory disorders as well as establish dose levels for initial clinical evaluation for specific types of cancer. Phase II studies are projected to start mid-2023.
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EP282 is a proprietary, oral, small molecule FFAR2 agonist discovered and developed at Epics Therapeutics. "We are the first company to bring an FFAR2 agonist into clinical development. FFAR2 is the focus of numerous published reports from the research community as it is an exciting target linking the microbiome with defence against intestinal infection, inflammation and cancer remission. Our preclinical dataset, in agreement with the published reports, indicates that our drug candidate represents a safe and powerful new approach for addressing the unmet medical needs in the treatment of gastrointestinal disorders and certain cancers" stated Jean Combalbert, CEO.