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FDA guidance for Phase III B-SIMPLE 4 trial of SB 206 to treat molluscum contagiosum.- Novan Inc.

Written by | 1 May 2020 | COVID-19

Novan, Inc.has announced that the Company has received meeting minutes from the April 1, 2020 Type C meeting with the FDA regarding SB 206 for the treatment of molluscum contagiosum (“molluscum”). Based on guidance the Company received during the meeting and subsequently contained within the meeting minutes, Novan is preparing to conduct one additional pivotal trial (“B-SIMPLE4”), which, if successful, could be supported by the previously completed B-SIMPLE2 trial in a future New Drug Application (“NDA”).

In addition, the FDA provided guidance with regard to the study design for B-SIMPLE4 and expectations for a future NDA submission, which has been incorporated in the B-SIMPLE4 preliminary trial design characteristics.

B-SIMPLE 4 Design Characteristics: Number of patients: approximately 750 (1:1 randomization).Stratification: investigator type, subjects per household and inflammation of molluscum lesions as measured by BOTE1 (beginning of the end).Primary endpoint: proportion of patients with complete clearance of all treatable molluscum lesions at Week 12 (Intent-to-Treat or “ITT” population, where the analysis assumes that patients with missing data at Week 12 are assessed as treatment failures).Visits: Screening/Baseline, Week 2, Week 4, Week 8, Week 12 and safety follow-up at Week 24. Implementation of additional patient and caregiver training and retention efforts. Use of decentralized visit capabilities for conduct during COVID-19 pandemic.

Novan plans to send the proposed protocol to the FDA in the near term. The Company has begun the planning and start-up phase for B-SIMPLE4. Novan is targeting enrolling the first patient for B-SIMPLE4 in September 2020, and if the trial is initiated on this timetable, the Company would expect top-line efficacy results late in the second quarter of 2021. The initiation and execution of B-SIMPLE4, beyond the start-up phase, is subject to additional funding or strategic partnering and may be further impacted by the COVID-19 pandemic.

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