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Celsius Assessing Safety of Inflammatory Bowel Disease Drug in First-in-Human Study

NEW YORK – Celsius Therapeutics, a company developing precision inflammatory bowel disease treatments, has begun dosing healthy volunteers in a first-in-human Phase I trial of its investigational anti-TREM1 antibody CEL383.

In this study, Celsius is aiming to enroll 48 participants and randomize them to receive either ascending doses of CEL383 or a placebo. The Cambridge, Massachusetts-based firm is evaluating CEL383's safety, tolerability, and pharmacokinetics, and is conducting an exploratory assessment to gauge if the drug engages its target.

Celsius designed CEL383 to inhibit TREM1 signaling and lower levels of clinically relevant inflammatory mediators. The firm has also identified biomarkers of TREM1 pathway dependence that it hopes to use to identify which patients with inflammatory bowel disease are likely to respond to CEL383.

According to Celsius President and CEO Tariq Kassum, there is evidence suggesting that TREM-1 plays a key role in chronic inflammatory conditions such as ulcerative colitis and Crohn's disease. "We believe a precision therapy like CEL383 has the potential to offer a clinically meaningful treatment option that could improve the quality of life for people suffering with inflammatory bowel disease," Kassum said in a statement.