Clinical data for berdazimer gel, 10.3% (SB 206), to treat molluscum contagiosum to be presented at the annual meeting of the Society for Investigative Dermatology.
Novan, Inc. announced it will present Beginning of The End (BOTE) clinical data from its previously completed Phase III trial of berdazimer gel, 10.3% for molluscum contagiosum (“molluscum”), B-SIMPLE4, at the Annual Meeting of the Society for Investigative Dermatology (SID) being held May 18-21, 2022 in Portland, Oregon.
About the Poster Presentation: Abstract: #294. Title: "BOTE (Beginning Of The End) inflammation can be enhanced with SB 206, a nitric oxide-releasing topical medication for molluscum contagiosum"; Authors: Tomoko Maeda-Chubachi, MD, PhD, MBA, Martina Cartwright, PhD, Amy Paller, MD.
In June 2021, Novan reported statistically significant positive topline results for the primary efficacy endpoint (p-value <0.0001) of complete clearance of all treatable lesions in its b-simple4 pivotal phase iii clinical study of berdazimer gel, 10.3% for the treatment of molluscum. additionally, and consistent with results from the company’s prior phase ii and phase iii studies, berdazimer gel, 10.3% was found to be well tolerated in the b-simple4 study and met company expectations. no treatment-related serious adverse events were reported.
BOTE sign observed in molluscum patients is known to be a sign of resolving molluscum contagiosum infection, but BOTE was never prospectively studied. Based on Novan’s B-SIMPLE4 study data, patients with a positive BOTE sign (BOTE+) at baseline had greater lesion reduction and clearance by Week 12 than patients with no BOTE or a negative BOTE sign (BOTE-) at baseline, supporting the hypothesis that BOTE sign predicts molluscum contagiosum resolution. Patients who were both BOTE+ at baseline and treated with berdazimer gel, 10.3% had the greatest chance of molluscum clearance. The mechanism by which nitric oxide release hastens molluscum clearance is unknown but may be due in part to immunomodulatory activity as indicated by induction of BOTE, although other mechanisms may be involved. For more information about the B-SIMPLE4 study, please visit clinicaltrials.gov and reference identifier: NCT04535531.
There are currently no FDA approved prescription therapies for the treatment of molluscum. The Company believes that berdazimer gel, 10.3% as a topical, prescription, self- or caregiver-applied therapy with a rapid treatment benefit, if approved, would satisfy an important patient-care need for the treatment of molluscum.
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