Berdazimer gel safe, tolerable with minimal systemic exposure in molluscum contagiosum
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Berdazimer gel 10.3% was well tolerated with minimal systemic exposure in the treatment of children with molluscum contagiosum, according to a study published in the Journal of Drugs in Dermatology.
“Molluscum contagiosum (MC) is a highly contagious viral skin disease characterized by raised, umbilicated, pink-to-red lesions. It is estimated that 6 million Americans suffer from molluscum contagiosum, mostly children,” Martina M. Cartwright, PhD, vice president of medical affairs at NOVAN, and colleagues wrote. “FDA-approved prescription medication treatments for MC remain elusive, and an estimated two-thirds of patients with molluscum go untreated.”
According to the Cartwright and colleagues, berdazimer gel may be able to influence cellular and molecular aspects of MC pathogenesis because it acts like an antiviral and possibly contains immunomodulatory properties.
In this 12-week open-label, multicenter phase 1 trial, researchers assessed the safety, tolerability and pharmacokinetic (PK) parameters of berdazimer gel 10.3% in 34 patients (mean age, 5.3 years; age range, 2-12 years; 50% girls; 97.1% white). The mean MC lesion count at baseline was 50. The primary endpoint was the PK profile of the hydrolyzed N-methylaminopropyl-trimethoxysilane (hMAP3) monomer and nitrate — which would be markers for systemic exposure to berdazimer sodium — during a 2-week PK period when berdazimer gel was applied under maximal use conditions once a day. Safety and tolerability were then evaluated through the 10-week extension period.
During the PK period, researchers applied the once-daily gel on days 1, 8 and 15, whereas caregivers applied all other doses at home. The gel was still applied if lesions cleared.
Patients had no quantifiable plasma hMAP3 on day 1 of the study. On day 15, two patients displayed maximum hMAP3 concentrations of 33.9 ng/mL; however, this amount was more than 10-fold lower than the adverse effect level observed in an animal toxicology study, the researchers wrote. Mean nitrate concentration profiles remained flat throughout the PK period, and the highest plasma methemoglobin level observed was 3.2%, according to the study.
By week 12, the researchers found that the mean lesion count decreased from baseline by 68.4% and four patients also achieved complete MC clearance, including one with heightened hMAP3 levels on day 15.
According to the researchers, the most common treatment-emergent adverse events included application-site pain (38.2%) and application-site erythema (17.6%), with most adverse events being mild or moderate.
“This study supports the safety of berdazimer gel, 10.3% with respect to systemic exposure in children under maximal use conditions,” Cartwright and colleagues wrote. “Berdazimer gel, 10.3% is in late-stage clinical development and, if FDA-approved, would be the first prescription medication indicated for MC.”
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