Celldex laces up next to Big Pharma players as drug reduces severity of chronic hives

Celldex Therapeutics has some huge competition in immunology, but new phase 2 data from its monoclonal antibody showing a reduction in the severity of a chronic form of hives is helping put the biotech in the game. 

Barzolvolimab was tested in 208 patients to assess the mean change in hives from start to Week 12. Patients in the trial had moderate to severe chronic spontaneous urticaria (CSU) that is resistant to antihistamines. Some patients had previously received biologics to treat their condition. CSU means that hives have occurred for six weeks or longer without an identifiable trigger or cause. These patients are typically treated with Genentech and Novartis’ Xolair, but few options are available if that does not work.

Celldex reported that barzolvolimab reduced hives on a common score of urticaria activity by -23.87 from baseline in the 300-mg dose group, which featured 51 patients, according to a Monday press release. The 150-mg group of 52 patients saw a -23.02 change in score. The therapy met the primary endpoint of the study by spurring clinically meaningful and statistically significant decreases in the urticaria activity score, the company said. 

The therapy was well tolerated with a favorable safety profile, Celldex said. The company reported that most of the adverse events were mild to moderate in severity. The most common treatment-emergent adverse events in patients who received barzolvolimab were hair color changes, hives and neutropenia, which is low levels of certain white blood cells. The rates of neutropenia in the treatment arm and placebo group were similar, Celldex noted.

The data sent Celldex’s shares flying up 24% to $32 apiece as the market opened Monday, compared to $25.98 at close Friday.

CEO Anthony Marucci said the data reinforce the therapy’s mechanism of action that targets an underlying pathway of CSU. Celldex will now move toward registrational trials, he noted.

Full 12 week data will be shared at a future medical meeting. Treatment will also continue to 52 weeks for patients.

Celldex has some heavy hitters as competition in the immunology space. Last week, Sanofi said rilzabrutinib improved itch severity in a phase 2 trial of patients with CSU. The therapy was picked up from the $3.7 billion acquisition of Principia. The candidate missed in another midstage trial for atopic dermatitis.

But the French Pharma and partner Regeneron suffered a rare setback at the end of October for blockbuster Dupixent, which was rejected by the FDA for CSU. The agency requested additional efficacy data. The companies are currently conducting a phase 3 trial in the indication, which is due to read out at the end of next year and could provide the necessary evidence.  

Meanwhile, Novartis is fighting to hang on to the market with the BTK inhibitor remibrutinib. The therapy helped patients experience a significant improvement in urticaria activity score after 12 weeks in two phase 3 clinical trials, according to data posted in August.