Data continue to support ‘pipeline in a product’ hope for Celldex’s barzolvolimab
07 Nov 2023
Clinical ResultPhase 2
Celldex Therapeutics touted the “pipeline in a product” potential of its experimental drug barzolvolimab after reporting positive data for the monoclonal antibody in chronic spontaneous urticaria (CSU) and prurigo nodularis. The company plans to advance barzolvolimab into registrational studies in CSU next year, whilst kicking off mid-stage development in prurigo nodularis in early 2024.
Commenting on the results, Jefferies analysts said that in both conditions, the efficacy of barzolvolimab is “looking best-in-disease,” while there were no concerning safety signals. The analysts suggested that if this profile holds up, the drug – which that specifically binds the receptor tyrosine kinase KIT - will have a multi-billion-dollar market opportunity.
Results from a Phase II study in patients with CSU showed that the two higher doses of barzolvolimab were associated with a significant mean change from baseline to week 12 of the urticaria activity score over 7 days (UAS7) compared to placebo. Specifically, the mean change in UAS7 at week 12 for those given barzolvolimab at a dose of 300mg every 8 weeks was 23.87, while it was 23.02 in the group receiving 150mg every 4 weeks versus 10.47 for placebo.
According to Celldex, approximately 20% of patients in the study had received prior treatment with Roche and Novartis' Xolair (omalizumab). The company noted that these patients experienced a similar clinical benefit to the overall treated population..
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