It’s not easy to muscle in on a space as competitive as immunology, but Celldex Therapeutics believes that its latest phase 2 win in a chronic form of hives means it has a shot at carving out its own niche.
The study assessed data from 196 patients with one of the two most common types of chronic inducible urticaria (CIndU)—namely cold urticaria (ColdU) and symptomatic dermographism (SD)—some of whom had already tried antihistamine treatment. The results showed that 12 weeks after taking one of the two doses of the drug, barzolvolimab, hit the primary endpoint of producing a statistically significant increase in the number of patients who gave a negative result to a TempTest for ColdU or a FricTest for SD.
Specifically, 46.9% of patients who received a 150-mg dose every four weeks tested negative, and 53.1% who received a 300-mg dose every eight weeks tested negative, compared to 12.5% of those who received placebo.
Barzolvolimab was well tolerated with a favorable safety profile, Celldex said. The most common adverse events among treated patients were hair color changes (13%) and neutropenia (11%), the term for a low number of a type of white blood cell.
Barzolvolimab is a humanized monoclonal antibody that works by blocking the signaling of an enzyme called c-Kit on mast cells. In this morning’s release, Celldex CEO Anthony Marucci described the barzolvolimab as the first drug to “demonstrate statistically significant and clinically meaningful results in a large, randomized, placebo-controlled study in chronic inducible urticaria.”
“These data are unprecedented and clearly demonstrate that barzolvolimab has the potential to become a critically needed new treatment option for patients suffering from this disease,” Marucci added. “We look forward to advancing barzolvolimab into registrational studies in inducible urticaria and moving towards our goal of bringing this potential new medicine to patients.”
The latest phase 2 success follows a midphase trial in another type of hives called chronic spontaneous urticaria that read out in November 2023, showing that barzolvolimab spurred clinically meaningful and statistically significant decreases in the urticaria activity score. Specifically, a 300-mg dose reduced hives on a common score of urticaria activity by -23.87 from baseline, while the 150-mg group saw a -23.02 change.
At the time, analysts at William Blair said the results “have established cKIT inhibition as highly effective in urticarias with clear potential in additional indications.” Jasper Therapeutics has its own cKIT inhibitor called briquilimab in development for hives.
Celldex already announced plans earlier this month for a phase 3 trial of barzolvolimab that will enroll 1,800 patients with chronic spontaneous urticaria. The drug is also in a phase 2 study for a chronic skin disorder called prurigo nodularis.
Sanofi and Regeneron had plans to use its blockbuster Dupixent to take on Novartis and Roche’s Xolair’s domination of the chronic spontaneous urticaria market but these were blown off course by an FDA rejection last year. However, the French drugmaker hasn’t given up hopes in the space, posting phase 2 data in February suggesting it has a BTK inhibitor that may have a shot at the crown.