CERC-002, an investigational fully human anti-LIGHT (tumor necrosis factor superfamily member 14 -TNFSF14) monoclonal antibody significantly reduced mean LIGHT levels and resulted in clinically meaningful endoscopic improvement in a phase 1b trial for adults with moderate to severe Crohn’s disease, according to a press release from the manufacturer.

The investigational agent, CERC-002, is a first-in-class agent that utilizes anti-LIGHT monoclonal antibodies as the mechanism of action compared to most other on the market treatments that use anti-TNF alpha monoclonal antibodies. In this clinical trial, patients were given four doses of CERC-002 via subcutaneous injection every 14 days, first at 1mg/kg for two cycles, and then at 3mg/kg for two cycles, for a total of 8 weeks. 

The trial included 4 patients, ranging in age from 28-63, all of which had active moderate to severe Crohn’s disease with a simple endoscopic score for Crohn’s disease (SES-CD) of at least 7 and had previously failed at least one anti-TNF alpha treatment. After 8 weeks, there was clinically meaningful endoscopic improvement in 75% of patients when comparing pre- and post-trial colonoscopies. There were also no adverse events reported and no evidence of increased infection related to immunosuppression.

“Crohn's disease is a serious, chronic disease with symptoms and complications that can have a major impact on patients’ daily lives, and additional therapies are needed to improve the prognosis for many living with this inflammatory bowel disease,” Gerald W. Dryden, MD, PhD, MS, MSPH, study investigator and Professor of Medicine and Director of the Inflammatory Bowel Disease Program, Department of Medicine, Gastroenterology, Hepatology and Nutrition at the University of Louisville, said in the release. “This proof-of-concept study included patients with moderate to severe Crohn's disease who failed more than three biologic treatment alternatives with multiple mechanisms of actions and had very resistant disease. These positive results support further advancement as a potential new treatment option that may address the unmet needs of patients living with this challenging disease.”

Following phase 1b results, this clinical trial has been approved to continue exploring the dosage, safety, and efficacy of CERC-002 for adults with moderate to severe Crohn’s disease. 

More information on this currently ongoing clinical trial can be found on clinicaltrials.gov under the identifier: NCT03169894.