Celsius Therapeutics Announces Initiation of Dosing in Phase 1 Clinical Trial of CEL383, an Anti-TREM1 Antibody for the Treatment of Inflammatory Bowel Disease

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Celsius Therapeutics, a biotechnology company pioneering new precision medicines for patients with inflammatory disease by harnessing the power of single-cell RNA sequencing and human biology at scale, today announced the initiation of dosing in the company’s first-in-human Phase 1 clinical trial of CEL383 in healthy volunteers. CEL383 is a potential first-in-class anti-TREM1 antibody that Celsius is advancing for the treatment of inflammatory bowel disease (IBD).

“The initiation of this study marks an important milestone for Celsius as we advance the first clinical candidate identified through our SCOPE platform into the clinic,” said Tariq Kassum, M.D., President and CEO of Celsius. “A substantial and growing body of evidence shows that TREM-1 plays a central role in ulcerative colitis and Crohn’s disease, chronic inflammatory conditions that can significantly impact patient lives. 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 IBD.”

The first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study was designed to evaluate the safety, tolerability, and pharmacokinetics of CEL383 in healthy volunteers. Additionally, the study includes an exploratory assessment of target engagement as measured by receptor occupancy. To learn more about the CEL383 clinical trial, visit clinicaltrials.gov (Identifier: NCT05901883).

About CEL383

CEL383, Celsius’ first clinical candidate, is an antibody directed towards Triggering Receptor Expressed on Myeloid Cells 1 (TREM1). In preclinical assays, CEL383 has been shown to inhibit TREM1 signaling, reducing the levels of multiple inflammatory mediators of high clinical relevance in inflammatory conditions, such as TNFα and IL23. Celsius has also identified biomarkers of TREM1 pathway dependence that may enable a precision approach to patient selection for CEL383 in ulcerative colitis and Crohn’s disease.

About Celsius Therapeutics

Celsius Therapeutics is a clinical-stage biotechnology company developing novel precision medicines in inflammatory disease by harnessing the power of single cell RNA sequencing and human biology at scale. The company’s first therapeutic candidate is an anti-TREM1 antibody for the treatment of IBD. Celsius is based in Cambridge, Mass. For more information, please visit https://celsiustx.com, or follow us on LinkedIn or Twitter.

Katie Engleman, 1AB
katie@1abmedia.com