ABBV-8736 / AbbVie - LARVOL DELTA

AbbVie Acquires Celsius Therapeutics (PRNewswire) - "AbbVie...announced today the acquisition of Celsius Therapeutics, Inc...a privately held biotechnology company pioneering new therapies for patients with inflammatory disease. Celsius' lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody that has completed a Phase 1 clinical study for the treatment of IBD....Under the terms of the agreement, AbbVie has acquired all outstanding Celsius equity for $250 million in cash, subject to certain customary adjustments."

M&A • Inflammatory Bowel Disease

First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Celsius Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion

First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Celsius Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

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

Trial status • Immunology • Inflammatory Bowel Disease

First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Celsius Therapeutics, Inc.

New P1 trial

Single cell RNA sequencing of Ulcerative Colitis and Crohn's Disease tissue samples informs the selection of Triggering Receptors Expressed on Myeloid Cells 1 (TREM1) as a target for the treatment of Inflammatory Bowel Diseases (ECCO-IBD 2023) - "To identify potential mediators of persistent inflammation in inflammatory bowel disease (IBD), we performed single cell RNA sequencing on tissue samples collected from UC and CD patients before and after beginning adalimumab. Our single cell RNA sequencing data provide further evidence that TREM1 is an exciting therapeutic target for UC and CD. We therefore developed a highly potent and selective monoclonal antibody inhibitor of TREM-1, CEL383, with the Phase 1 clinical trial expected to start in 2023."

Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Celsius Therapeutics to Present Preclinical Data on Anti-TREM1 Antibody at 18th Congress of ECCO - Inflammatory Bowel Diseases (Businesswire) - "Celsius Therapeutics...announced that new data on CEL383, a potential first-in-class anti-TREM1 antibody for the treatment of inflammatory bowel disease (IBD), has been selected for a digital oral presentation at the 18th Congress of ECCO - Inflammatory Bowel Diseases, hosted by the European Crohn’s and Colitis Organisation from March 1-4, 2023, in Copenhagen, Denmark....'We anticipate filing an investigational new drug application for CEL383 with the U.S. Food and Drug Administration and commencing a Phase 1 clinical study in the first half of this year.'"

IND • New P1 trial • Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Celsius Therapeutics to Present Preclinical Data on Anti-TREM1 Antibody for Inflammatory Bowel Disease at 2023 Crohn’s & Colitis Congress (Businesswire) - "Celsius Therapeutics...announced that new data on CEL383, a potential first-in-class anti-TREM1 antibody for the treatment of inflammatory bowel disease (IBD), has been selected for oral presentation at the 6th Annual Crohn’s & Colitis Congress, taking place January 19-21, 2023, in Denver, Colorado....'These data demonstrate the power of our SCOPE platform (Single Cell Observations for Precision Effect) to create promising new therapeutics in IBD and other diseases,' said Tariq Kassum, M.D., President and CEO of Celsius. 'We anticipate filing an investigational new drug application for CEL383 with the U.S. Food and Drug Administration and commencing a Phase 1 clinical study in the first half of this year.'"

IND • New P1 trial • Preclinical • Crohn's disease • Immunology • Inflammatory Bowel Disease

SINGLE CELL RNA SEQUENCING OF ULCERATIVE COLITIS AND CROHN’S DISEASE TISSUE SAMPLES INFORMS THE SELECTION OF TREM1 AS A TARGET FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASES (CCCongress 2023) - "To identify potential mediators of persistent inflammation in inflammatory bowel disease (IBD), we performed single cell RNA sequencing on tissue samples collected from UC and CD patients before and after beginning adalimumab. Our single cell RNA sequencing data provide further evidence that TREM1 is an exciting therapeutic target for UC and CD, with inhibition of TREM1 signaling expected to address pathology while maintaining an anti-bacterial response. We therefore developed a highly potent and selective monoclonal antibody inhibitor of TREM-1, CEL383, with the Phase 1 clinical trial expected to start in 2023."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Rheumatology • Ulcerative Colitis

Celsius Therapeutics Highlights Recent Accomplishments and Key Initiatives for 2022 (Businesswire) - "Celsius today announced its first clinical candidate, CEL383, an anti-TREM1 antibody, for the treatment of IBD....The company anticipates filing an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) within the next year, with a Phase 1 study expected to commence in early 2023."

IND • New P1 trial • Inflammatory Bowel Disease