Novan Provides Pipeline and Priority Development Programs Update
September 14 2020 - 9:05AM
Novan, Inc. ("the Company" or "Novan") (Nasdaq: NOVN), today
provided a priority pipeline update. In addition to focusing its
primary efforts toward SB206, its lead product candidate for
molluscum, the Company is also directing pre-IND development
activities toward the ongoing in vitro work related to
coronaviridae, as well as exploring the potential of its NITRICIL™
platform technology for use in an antimicrobial indication for
companion animal health.
“Over the course of the past few months, we have
dedicated time and efforts evaluating our internal pipeline of
late-stage assets, our broader dermatology platform and underlying
NITRICIL™ technology. These components represent what we believe to
be a solid foundation to build momentum and support Novan’s next
phase of growth,” commented Paula Brown Stafford, Chairman,
President and Chief Executive Officer of Novan. “We are focused on
successfully executing our pivotal Phase 3 study of SB206 for the
treatment of molluscum, which is now underway and dosing patients,
and are pleased with the progress our team has continued to make in
this important program.”
Ms. Stafford continued, “Additionally, we have
continued to make progress with our in vitro work to evaluate the
ability of NITRICIL™ to target the replication mechanisms of
SARS-COV-2 (COVID-19) and target reporting of key findings from
these assessments before year end. I am also pleased to announce
that we have launched exploratory efforts to evaluate the use of
NITRICIL™ for antimicrobial indications in companion animal health,
an area we believe diversifies our pipeline and provides
opportunities in an adjacent, yet important market.”
SB206: Topical antiviral gel
for the treatment of viral skin infections, with a current focus on
the treatment of molluscum contagiosum, a contagious skin infection
caused by the molluscipoxvirus, a double-stranded DNA virus.
Program Highlights:
- B-SIMPLE4 pivotal Phase 3 study for treatment of molluscum
underway
- Target completion of enrollment in Q1 2021
- Topline results targeted for Q2 2021, subject to the timing and
trial execution plan which have been and may be further impacted by
the COVID-19 pandemic
For more information about the B-SIMPLE4 trial,
please visit clinicaltrials.gov and reference identifier:
NCT04535531.
Coronaviridae (COVID-19):
Currently conducting in vitro assessments to evaluate the ability
of NITRICIL™ to inhibit the replication mechanisms of SARS-COV-2
(COVID-19).
Program Highlights:
- Nitric oxide may inhibit viral replication by cytotoxic
reactions through intermediates such as peroxynitrite
- In vitro assessments targeting the reduction of viral shedding
and transmission
- Targeting year end to report findings from in vitro
assessments
Companion Animal Program:
Initiated exploratory work to evaluate NITRICIL™ as a potential
product candidate for antimicrobial indications in companion animal
health
Program Highlights:
- Contracted drug delivery technology specialist to undertake
initial formulation development to assess viability
- Engaged animal health experts to assess technical feasibility
and market potential
- Target seeking a potential strategic partner or collaborator
following initial proof-of-concept work
“In addition to advancing our priority
development programs, we also have a rich pipeline of potential
expansion opportunities in dermatology, men’s and women’s health,
and gastroenterology conditions with significant unmet needs. We
are continuing our review of existing programs and opportunities
that could expand our priority development efforts,” concluded Ms.
Stafford. About Novan
Novan, 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 (NCE’s) 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 Statements
This press release contains forward-looking
statements including, but not limited to, statements related to
pharmaceutical development of nitric oxide-releasing product
candidates and our intention to advance development of certain
product candidates and the timing of reporting findings or results
from our programs currently in process. Forward-looking statements
are subject to a number of risks and uncertainties that could cause
actual results to differ materially from our expectations,
including, but not limited to, risks and uncertainties in our
ongoing or future product development activities and preclinical
studies, which may not prove successful in demonstrating proof-of
concept, or may show adverse toxicological findings, and even if
successful may not necessarily predict that subsequent clinical
trials will show the requisite safety and efficacy of our product
candidates; risks and uncertainties in the clinical development
process, including, among others, length, expense, ability to
enroll patients, reliance on third parties, 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 our product candidates may not be approved or that additional
studies may be required for approval or other delays may occur and
that we may not obtain funding sufficient to complete the
regulatory or development process; our ability to obtain additional
funding or enter into strategic or other business relationships
necessary or useful for the further development of our product
candidates; the risk that disruptions at the FDA 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 our regulatory
submissions, all of which could have a material adverse effect on
our business; risks related to the manufacture of clinical trial
materials; any operational or other disruptions as a result of the
COVID-19 pandemic, including any delays or disruptions to the
enrollment in and conduct of the B-SIMPLE4 Phase 3 trial; and other
risks and uncertainties described in our annual report filed with
the SEC on Form 10-K for the twelve months ended December 31, 2019,
as amended, and in our subsequent filings with the SEC. These
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.
INVESTOR AND MEDIA CONTACT:
Jenene Thomas JTC Team,
LLC833-475-8247NOVN@jtcir.com
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