– SB206 demonstrates continued favorable safety profile consistent with previous studies and meets Company’s expectations –
– Pre-NDA meeting with the FDA, as well as conduct of customary stability testing, targeted for 1H 2022 –
– Potential NDA submission on track, targeting Q3 2022 –
DURHAM, N.C., Sept. 23, 2021 (GLOBE NEWSWIRE) — Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today announced the comprehensive safety data readout as part of the Company’s B-SIMPLE4 pivotal Phase 3 study of SB206 for the treatment of molluscum contagiosum (“molluscum”).
B-SIMPLE4 was a multi-center, double-blind, randomized, vehicle-controlled study that exceeded its enrollment target by randomizing 891 patients (1:1 randomization) in the study, across 55 clinical sites. Patients were treated for up to 12 weeks with a follow-up visit at Week 24. The primary endpoint for the study is the proportion of patients with complete clearance of all treatable molluscum lesions at Week 12.
“We are pleased to see the comprehensive results from the B-SIMPLE4 study and that there is little difference between the reported Week-24 and Week-12 safety data; all of which are in line with our expectations. We believe the safety profile of SB206 remains attractive and consistent across all three of our Phase 3 studies,” commented Tomoko Maeda-Chubachi, M.D., Ph.D., MBA, Chief Medical Officer of Novan. “If approved, SB206 should provide a great treatment option to patients and caregivers who can easily and conveniently apply at home.”
In June 2021, Novan reported statistically significant positive topline results for the primary endpoint (p-value <0.0001) of complete clearance of all treatable lesions at Week 12 in its B-SIMPLE4 pivotal Phase 3 clinical study of SB206. Consistent with results from the Company’s prior Phase 2 and Phase 3 studies, SB206 was also found to be safe and well tolerated in the B-SIMPLE4 study at Week-12. In July 2021, the Company announced that the last patient had completed their planned Week-24 follow-up visit in the B-SIMPLE4 study.
“I am thrilled with the B-SIMPLE4 efficacy and final safety data for Novan’s SB206 product candidate for the treatment of molluscum, demonstrating clinically meaningful results. Patients and caregivers are currently faced with often painful in-office, dermatologist-administered physical removal or blistering procedures, and SB206 would be a welcome at-home solution for physicians like me,” commented John Browning, M.D., F.A.A.D, F.A.A.P., MBA, Adjunct Associate Professor of Pediatrics and Dermatology at UT Health San Antonio and Baylor College of Medicine, and a Principal Investigator in the B-SIMPLE4 study.
The treatment emergent adverse events (“TEAEs”) profile of SB206 through the Week-24 visit was found to be favorable and consistent with the previous Phase 3 studies, B-SIMPLE1 and B-SIMPLE2. The TEAEs reported in greater than 5% of subjects in the SB206 treated groups were all at the application site (pain, erythema, pruritis, exfoliation, and dermatitis) with the high majority of these TEAEs being mild or moderate by severity.
Table 1: Overall Summary of TEAEs (Safety Population)
|SB206 (n=444)||Vehicle (n=447)|
|Subjects with at least one…|
|TEAE||191 (43.0%)||103 (23.0%)|
|Treatment-related TEAE||163 (36.7%)||54 (12.1%)|
|TEAE leading to study drug discontinuation||18 (4.1%)||3 (0.7%)|
Study drug discontinuations in the SB206 treatment arm were all due to application site reactions and no treatment-related serious adverse events were reported at or before Week 24. The Week-24 visit was designed to further evaluate the safety of SB206, 12 weeks following completion of the initial 12-week study period.
Table 2: Overall Summary of Post Treatment Adverse Events (Safety Population)
|SB206 (n=444)||Vehicle (n=447)|
|Subjects with at least one…|
|Adverse Event (“AE”)||75 (16.9%)||68 (15.2%)|
|Treatment-related AE||24 (5.4%)||14 (3.1%)|
Molluscum, caused by the molluscipoxvirus, is known to occasionally heal with some scarring, or small pitting at the lesion site. Scar formation was assessed by the investigator, regardless of the size of the scar, throughout the study for TEAEs, as well as occurrence. The TEAEs for scarring throughout the study were slightly higher in the vehicle group (6.3%) vs. SB206 (4.7%). Subjects treated with SB206 showed a lower occurrence of scarring at the Week-24 visit when compared to vehicle (4.0% in vehicle vs. 2.7% in SB206). These findings were generally consistent with observations from B-SIMPLE1 and B-SIMPLE2.
Paula Brown Stafford, President and Chief Executive Officer, commented, “Now with these safety data in hand, combined with our robust clinical efficacy data, we look forward to sharing our promising data package from the B-SIMPLE program with the FDA during a pre-NDA meeting targeted in the first half of 2022, as we pursue our path forward for Novan’s SB206 molluscum product candidate in the U.S.”
The Company plans to present topline efficacy and safety results at upcoming medical congresses and conferences.
Novan, Inc. is a pre-commercial nitric oxide-based pharmaceutical company focused on dermatology and anti-infective therapies. We leverage our core synergies of science, capital, resources and patient needs to create value by bringing new nitric oxide-based medicines to market. Our goal is to create the world’s leader in nitric oxide-based science, technology, and clinical translation in support of delivering safe and efficacious therapies using our proprietary nitric oxide-based technology platform, NITRICIL™ to generate macromolecular New Chemical Entities (NCEs) to treat multiple indications.
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “target,” “anticipate,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on the Company’s current beliefs and expectations. These forward-looking statements include, but are not limited to, statements related to the potential therapeutic value of the Company’s NITRICIL™ platform technology, the Company’s pharmaceutical development of nitric oxide-releasing product candidates, including SB206, and the potential timing of clinical trials, stability testing and FDA submission(s). Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from the Company’s expectations, including, but not limited to, risks related to the regulatory approval process, which is lengthy, time-consuming and inherently unpredictable, including the risk that the FDA will not agree with the Company’s approach to a potential NDA submission, that the Company’s product candidates may not be approved or that additional studies may be required for approval or other delays may occur, that the Company may not have sufficient quantities of drug substance and/or drug product to support regulatory submissions and that the Company may not obtain funding sufficient to complete the regulatory or development process; the Company’s limited experience as a company in obtaining regulatory approvals and commercializing pharmaceutical products; changes in the size and nature of the market for our product candidates, including potential competition; any operational or other disruptions as a result of the COVID-19 pandemic; the Company’s ability to obtain additional funding or enter into strategic or other business relationships necessary or useful for the further development or commercialization of the Company’s product candidates; risks related to the manufacture of raw materials, including the Company’s active pharmaceutical ingredient and drug product components utilized in clinical trial materials, including supply chain disruptions or delays, failure to transfer technology and processes to third parties effectively or failure of those third parties (or the Company in connection with the upfit of the Company’s new facility) to obtain approval of and maintain compliance with the FDA or comparable regulatory authorities; the Company’s reliance on arrangements with third parties to support its operations and development efforts and the risk that such parties will not successfully carry out their contractual duties or meet expected deadlines; and other risks and uncertainties described in the Company’s annual report filed with the Securities and Exchange Commission on Form 10-K for the twelve months ended December 31, 2020, and in the Company’s subsequent filings with the Securities and Exchange Commission. Such forward-looking statements speak only as of the date of this press release, and Novan disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.
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