Novan, Inc., announced today the publication of positive efficacy and safety data from its completed B-SIMPLE 4 pivotal Phase 3 clinical study evaluating berdazimer gel, 10.3% for the treatment of molluscum in the peer-reviewed journal, JAMA Dermatology.1 Berdazimer gel, 10.3%, Novan potential first-in-class topical nitric oxide-based prescription treatment, demonstrated favorable efficacy and safety.
“Results from the B-SIMPLE 4 clinical study strongly demonstrate the promise of berdazimer gel, 10.3% as a potential first and only prescription medication for molluscum. The ability for the patient/caregiver to apply a nitric oxide-releasing topical gel to lesions that facilitates complete clearance is a breakthrough in molluscum treatment since many go untreated due to limited options. These study results also showed favorable tolerability which is a key factor in treating children,” said Adelaide Herbert, M.D., Chief of Pediatric Dermatology at McGovern School of Medicine and Children’s Memorial Hermann Hospital.
Berdazimer Sodium in Molluscum Patients with Lesions (B-SIMPLE) 4, was a multicenter, vehicle-controlled, double-blind study, which enrolled 891 patients across 55 clinics in the United States that were 6 months or older with 3 to 70 raised molluscum lesions. Enrolled patients were randomized to treatment with berdazimer gel, 10.3% (n=444), or vehicle gel (n=447), applying a thin layer to lesions once daily for 12 weeks. At the end of 12 weeks, 32.4% of patients in the berdazimer group achieved complete clearance of lesions as compared to 19.7% in the vehicle group. Adverse event rates were low, the most common were mostly mild application-site pain and erythema.
Secondary efficacy endpoints were favorable toward berdazimer gel, 10.3% treatment, with 43.5% (193/444) of berdazimer gel, 10.3% achieving a lesion count of 0 or 1 at week 12 versus 24.6% (110/447) of vehicle patients. Similarly, 43.0% (191/444) of those treated with berdazimer gel, 10.3% had a ≥90% reduction from baseline in the number of molluscum lesions at week 12, compared with 23.9% (107/447) of vehicle patients.
“If approved, berdazimer gel 10.3% could offer pediatricians a way to initiate molluscum treatment with a topical prescription. Unlike current molluscum treatments, like cantheradin or curettage, which often require more than one in-office application, berdazimer could provide molluscum patients or their caregivers the ease of self-applying the gel on the lesions,” said Stephan W. Stripling, MD, Co-Medical Director, Coastal Pediatric Research, Charleston, SC.