Novan Inc (NASDAQ:NOVN) commenced a double-blind, multi-center, vehicle-controlled, and randomized Phase 3 clinical study of SB206 to cure molluscum (molluscum contagiosum). It opened clinical sites to recruit patients.
Several million in the US suffer from molluscum
Annually several million Americans that include children below the age of 14 are suffering from molluscum. Molluscipoxvirus causes contagious skin disease. An antiviral gel SB206 offers an excellent substitute for the caregivers and patients to treat molluscum. The OTC treatments and off-the label prescriptions possess an unknown safety profile and clinical efficacy.
B-SIMPLE4 clinical trial
If the clinical trials are successful, SB206 could address a significant unmet need and offers patients an effective treatment for molluscum. In the B-SIMPLE4 clinical study, the company will enroll 750 patients at 45 sites for 12 weeks trial. It will be followed up with a visit to 24-week.
The primary endpoint of Phase 3 clinical trial of SB206 is to get skin free from molluscum lesions at the 12-week. CEO of Novan, Paula Brown Stafford, said the company is excited to begin the B-SIMPLE4 clinical study. She praised the team for continuing the clinical trials during the ongoing coronavirus. The company relentlessly worked with trial sites, enrolling patients actively, and expect to complete the enrollment in Q1 2021.
Topline results of SIMPLE4 clinical trial in Q2 2021
Novan expects to report topline results of Phase 3 clinical trial of SB206 in Q2 2021. However, it is subject to the timely recruitment of the patients and the trial’s execution plan, which may get impacted by the ongoing coronavirus.
Novan is conducting a Phase 3 clinical trial after receiving guidance from the US FDA during its Type C meeting. If it could achieve success in Phase 3 clinical trial, an NDA filing can be submitted to the FDA to support the previously concluded SIMPLE2 clinical study. No FDA approved therapies exist in the market to treat molluscum.
Robert Ingram retires as EC
Robert Ingram will be retiring from the Executive Chairman position. However, he will continue as a board member. With effect from July 28, 2020, Stafford will assume the role of EC as well. She played a vital role at the helm in raising the capital for advancing the Phase 3 clinical study.