Celldex Therapeutics (NASDAQ:CLDX) added ~12% marking the biggest intraday gain since November after the biotech announced early-stage results for its experimental monoclonal antibody barzolvolimab from patients with the skin condition urticaria.
Citing data from a Phase 1b trial involving patients with moderate to severe chronic spontaneous urticaria (CSU), Celldex (CLDX) said 56% of them showed a complete response at Week 12 in the 1.5 mg/kg, 3.0 mg/kg, and 4.5 mg/kg dose groups. Meanwhile, 76% of patients had well-controlled disease.
Additionally, the clinical benefit in 37% of those who had previously received omalizumab was found to be similar to the overall population. Omalizumab is an FDA-approved CSU therapy marketed by Novartis (NVS) and Roche (OTCQX:RHHBY),
The 45-patient trial tested intravenous barzolvolimab across four dose groups as an add-on treatment to H1-antihistamines alone or in a combination regimen with H2-antihistamines and/or leukotriene receptor agonists.
Additional data indicate that following the 12-week treatment period, 53% of patients in the 1.5 mg/kg and 3.0 mg/kg dose groups demonstrated complete response, while 70% witnessed well-controlled disease at Week 24.
The investigational therapy was well tolerated indicating a favorable safety profile. The effects of multiple-dose administration were consistent with data from single-dose studies.
Celldex (CLDX) has planned further studies for barzolvolimab in CSU with topline data from a Phase 2 trial expected later this year or in Q1 2024.
Ahead of the readout, Seeking Alpha contributor Avisol Capital Partners highlighted the promising early data from barzolvolimab