Celldex's anti-cKIT antibody reduces chronic hives in phase 2 trial

In the competitive field of immunology, Celldex Therapeutics believes its recent phase 2 success in treating a chronic form of hives, known as chronic inducible urticaria (CIndU), signifies a potential to establish its own niche. The study evaluated 196 patients suffering from two common types of CIndU—cold urticaria (ColdU) and symptomatic dermographism (SD)—including some who had previously been treated with antihistamines. The results revealed that 12 weeks after administering one of two doses of the drug barzolvolimab, there was a statistically significant increase in the number of patients who tested negative in a TempTest for ColdU or a FricTest for SD.

Specifically, 46.9% of patients receiving a 150-mg dose every four weeks, and 53.1% of those receiving a 300-mg dose every eight weeks, tested negative. This is in contrast to just 12.5% in the placebo group. Celldex reported that barzolvolimab was well tolerated, showing a favorable safety profile. The most common adverse events observed were hair color changes (13%) and neutropenia (11%), which refers to a low level of a specific type of white blood cell.

Barzolvolimab is a humanized monoclonal antibody that functions by inhibiting the signaling of an enzyme called c-Kit on mast cells. Celldex CEO Anthony Marucci highlighted the remarkable nature of these findings, stating that barzolvolimab is the first drug to show statistically significant and clinically meaningful results in a large, randomized, placebo-controlled study for chronic inducible urticaria. He emphasized that these unprecedented data point to barzolvolimab's potential as a much-needed new treatment option for patients suffering from this condition. Marucci expressed the company's eagerness to advance barzolvolimab into registrational studies for inducible urticaria and work towards bringing this promising new medicine to patients.

This phase 2 achievement follows a mid-phase trial in November 2023 for another type of hives, chronic spontaneous urticaria. The previous trial results demonstrated that barzolvolimab significantly reduced symptoms, with a 300-mg dose decreasing the urticaria activity score by -23.87 from baseline, and the 150-mg dose showing a reduction of -23.02. Analysts at William Blair remarked that these results have established cKIT inhibition as a highly effective approach in treating urticarias, with potential applications in other indications. Meanwhile, Jasper Therapeutics is also developing a cKIT inhibitor named briquilimab for hives treatment.

Earlier this month, Celldex announced plans to initiate a phase 3 trial of barzolvolimab, which will include 1,800 patients with chronic spontaneous urticaria. Additionally, the drug is currently being tested in a phase 2 study for prurigo nodularis, a chronic skin disorder.

Sanofi, another major player in the field, had intended to challenge the dominant position of Novartis and Roche's Xolair in the chronic spontaneous urticaria market using its blockbuster drug Dupixent. However, these plans were disrupted by an FDA rejection last year. Despite this setback, the French pharmaceutical company remains hopeful, as it released phase 2 data in February indicating that its BTK inhibitor might still compete effectively in this space.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!