Novan Inc (NASDAQ:NOVN) enrolled 525 patients for Simple4 Phase 3 clinical trial. It exceeds 60% enrollment of 825 patients and expects to complete the process in Q1 2021.
Treatment for contagious skin infection
The main aim of phase 3 clinical trial is to obtain topline efficacy results of the antiviral gel – SB206 to cure Molluscum contagiosum. Around 6 million Americans are suffering from this disease annually. Molluscipoxvirus causes contagious skin infection. It is more common in children aged between one and 14 years.
A multicenter and randomized clinical trial
Novan will conduct a randomized, double-blind, and multicenter clinical trial of SB206 across 50 sites in the US. It will administer the treatment for 12 weeks and again at week 24. The company plans to completely treat lesions of Molluscum at week 12 as a primary endpoint in a majority of the patient population.
60% enrollment for a clinical trial is noteworthy
CEO of Novan, Paula Brown Stafford said it is noteworthy to enroll 60% of patients for this pivotal clinical trial amid the ongoing coronavirus pandemic. He further said the company is encouraged with the enthusiasm for the unmet medical need and expects that SB206 will offer a potential treatment for Molluscum contagiosum.
Novan anticipates topline efficacy results of the antiviral gel – SB206 in Q2 2021. Currently, no FDA approved treatments exist in the market for patients suffering from molluscum. The company expects to provide rapid treatment at home for patients with contagious skin infection soon.
Patients suffering from this contagious skin infection expect to have nearly 100 lesions. Since the disease is more prevalent among children, parents are the caregivers and expect to achieve a quick cure with SB206 antiviral gel.
Signs MSA with Catalent to treat COVID-19
Novan entered a pact with Catalent to develop intranasal formulation using berdazimer sodium for the patients suffering from COVID-19. As part of the agreement, Catalent will provide control, manufacturing, and chemistry activities for the development of intranasal formulation.
Paula commenting on the development said the company is pleased to work with Catalent and expects to utilize its expertise in the production and development of the drug.