Novan Announces Final Week-12 Visit for Last Patient in B-SIMPLE4 Pivotal Phase 3 Study of SB206 for Treatment of Molluscum
May 03 2021 - 7:30AM
Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced the final patient has completed their last Week-12 visit
in the B-SIMPLE4 pivotal Phase 3 clinical study of SB206, a topical
antiviral gel, for the treatment of molluscum contagiosum
(“molluscum”). Topline efficacy and safety results from the
B-SIMPLE4 study are targeted to be reported before the end of the
second quarter of 2021.
“We are incredibly pleased with the progress we
have continued to make as we advance our lead program. We remain
focused on executing our remaining steps according to plan and
reporting topline efficacy and safety data in June. On behalf of
Novan, I would like to extend our sincere gratitude to the
patients, families and clinical staff that have participated in the
study,” commented Paula Brown Stafford, President and Chief
Executive Officer of Novan. “Each patient will visit their
physician one more time, at Week 24, and the study is expected to
fully complete in the third quarter, although no additional
efficacy data will be collected at that time.”Molluscum contagiosum
is a common, contagious skin infection caused by the
molluscipoxvirus, affecting up to six million people in the U.S.
annually, with the greatest incidence in children aged one to 14
years. Infected children typically present with 10-30 painless, yet
unsightly lesions, and, in severe cases, patients present with
around 100 lesions.
“There remains an unmet need in the treatment
landscape of molluscum, which affects millions of people each year
and primarily children under the age of 10. Our product candidate,
SB206, represents a promising opportunity to provide patients with
treatment benefit and address the unmet needs in the treatment
landscape for molluscum. Depending on the results of the B-SIMPLE4
Phase 3 trial, we are targeting a potential NDA filing no later
than the third quarter of 2022,” stated Tomoko Maeda-Chubachi,
M.D., Ph. D., M.B.A., Senior Vice President, Medical at Novan.
B-SIMPLE4 is a multi-center, double-blind,
randomized, vehicle-controlled study. The Company exceeded its
enrollment target by randomizing 891 patients (1:1 randomization)
in the study, across 55 clinical sites, due to the number of
patients in screening at the time of achieving the planned
enrollment goal. Patients have been 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 (Intent-to-Treat or “ITT” population,
where the analysis assumes that patients with missing data at Week
12 are considered treatment failures).
There are currently no U.S. Food and Drug
Administration (“FDA”) approved therapies for the treatment of
molluscum. The Company believes that SB206 as a topical, at-home,
self or caregiver-applied therapy with a rapid treatment benefit,
if approved, would satisfy an important patient-care need for the
treatment of molluscum.
For more information about the B-SIMPLE4 study,
please visit clinicaltrials.gov and reference identifier:
NCT04535531.
About NovanNovan, Inc. is a
clinical development-stage biotechnology company focused on
leveraging its proprietary nitric oxide (NO) based technology
platform, NITRICIL™ to generate macromolecular New Chemical
Entities (NCEs) to treat multiple indications in dermatology, men’s
and women’s health, infectious diseases and gastroenterology
conditions with significant unmet needs. The Company’s lead product
candidate, SB206, a topical antiviral gel, for the treatment of
molluscum contagiosum, is currently being evaluated in the
B-SIMPLE4 pivotal Phase 3 clinical study. The Company believes that
SB206 as a topical, at-home, caregiver-applied therapy with a rapid
treatment benefit, if approved, would address an important
patient-care need for the treatment of molluscum.
Forward-Looking StatementsAny
statements contained in this press release or in the announced
presentation 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,” “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 and the Company’s intention to
advance development of certain product candidates. 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 and
uncertainties in the Company’s ongoing or future product
development activities; any operational or other disruptions as a
result of the COVID-19 pandemic, including any delays or
disruptions to the conduct of the B-SIMPLE4 study; risks and
uncertainties in the clinical development process, including, among
others, length, expense, ability to enroll patients, potential for
delays or other impacts, whether as a result of the COVID-19
pandemic or other factors, and that results of earlier research and
preclinical or clinical trials may not be predictive of results,
conclusions or interpretations of later research activities or
additional trials; risks related to the regulatory approval
process, which is lengthy, time-consuming and inherently
unpredictable, including the risk that the Company’s product
candidates may not be approved or that additional studies may be
required for approval or other delays may occur and that the
Company may not obtain funding sufficient to complete the
regulatory or development process; the Company’s ability to obtain
additional funding or enter into strategic or other business
relationships necessary or useful for the further development of
the Company’s product candidates; the risk that disruptions at the
U.S. Food and Drug Administration or other agencies could cause
such agencies to cancel or postpone meetings or otherwise impact
the ability of such agencies to provide regulatory guidance or
feedback or timely review and process the Company’s regulatory
submissions, all of which could have a material adverse effect on
the Company’s business; 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 failure to transfer technology and processes to third
parties effectively or failure of those third parties to obtain
approval of and maintain compliance with the U.S. Food and Drug
Administration 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 SEC on Form 10-K for the
twelve months ended December 31, 2020, and in the Company’s
subsequent filings with the SEC. Such forward-looking statements
speak only as of the date of this press release or the announced
presentation, as applicable, 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. INVESTOR
AND MEDIA CONTACT:Jenene Thomas JTC Team,
LLC833-475-8247NOVN@jtcir.com
Novan (NASDAQ:NOVN)
Historical Stock Chart
From Apr 2024 to May 2024
Novan (NASDAQ:NOVN)
Historical Stock Chart
From May 2023 to May 2024