Celldex has just released positive results from a Phase 1 trial of an investigative therapy which could benefit patients living with chronic urticarias.

This disease can result in decreased energy, insomnia, social withdrawal, and even depression. It significantly impacts patient’s quality of life, and there has yet to be a treatment approved which targets the disease.

This Phase 1 study utilized healthy volunteers to investigate CDX-0159, a KIT inhibitor.

About The Therapy

CDX-0159 is a type of monoclonal antibody. It works by binding to the KIT receptor called tyrosine kinase, stopping its activity. This receptor is responsible for mediating the inflammatory response in the body. But current treatments for urticarias don’t focus on these cells. Instead, they only provide relief for symptoms.

That means this therapy could be a first ever treatment for chronic urticarias which actually targets the disease at its root. In addition to this condition, Celldex is examining whether this therapy could be beneficial for other mast cell diseases.

About the Study

The Phase 1 study was randomized, placebo-controlled, and double-blind. It aimed to evaluate the safety of CDX-0159 as well as its tolerability, immunogenicity, and the pharmacokinetics/pharmacodynamics. There were a total of 32 individuals involved in the study, all who were healthy subjects. Each participant received one IV infusion of the therapy at one of 4 dose levels, or the placebo treatment.

Results

This treatment was found to have a good safety profile. Most AEs were reactions to the infusion, and were mild. Some participants also experienced mild reductions in white blood cells and neutrophils.

Most importantly, the suppression of tryptase was profound, just with one dose of the therapy. This was maintained for over 2 months for participants who received a 3.0 or 9.0 mg/kg dose.

This means further research on the therapy is warranted and researchers are excited.

Looking Forward

Celldex is continuing their CDX-0159 program in both chronic urticarias and other conditions which are driven by mast cells. This year, they are beginning trials (Phase 1b) for chronic inducible urticaria (CINDU) as well as chronic spontaneous urticaria (CSU). Full results from these studies should be announced by the second half of next year.

You can read more about this investigative therapy here.