Number of Patients with Complete
Clearance of Genital Warts Provides Clinical
Evidence of Nitric Oxide Anti-Viral Activity Against
HPV
Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today
announced top-line results from the Company’s Phase 2 clinical
trial with SB206 for the treatment of genital warts caused by
human papillomavirus, or HPV. The highest dose tested, SB206 12%,
demonstrated a statistically significant improvement (p<0.05) in
the incidence of complete clearance of all baseline warts compared
to vehicle treatment after 12 weeks in both the intent-to-treat and
per-protocol analyses. “These data are impressive. The
magnitude of effect with favorable tolerability provides us great
enthusiasm for patients suffering from the most common sexually
transmitted infection in the United States,” said Nathan Stasko,
PhD, President and Chief Executive Officer of Novan. “Importantly,
SB206 represents another drug candidate from our platform that has
now shown the repeatability of taking a fundamental nitric oxide
mechanism of action, generating compelling preclinical evidence and
then translating that success into statistically significant
results in Phase 2 clinical trials. Genital warts was our first
viral target, and as we develop SB206 further we intend to
diligently investigate the numerous other viral skin infections in
need of new treatment options.”
In this randomized, double-blind,
vehicle-controlled clinical trial, the safety and efficacy of SB206
was evaluated in 107 patients with external genital warts and
perianal warts. The dose and dosing frequency of SB206 was tested
in four independent cohorts in which patients were randomized in a
3:1 ratio to either SB206 or vehicle and treated for up to 12
weeks. SB206 doses included SB206 4% twice-daily, 4% once-daily, 8%
once-daily and the highest dose evaluated, 12% once-daily. Patients
eligible for this clinical trial were males or females, 18 to 50
years of age, with 2 to 20 warts on the genital or perianal area.
The mean wart count burden per patient at baseline was 7.4
warts.
The primary endpoint for this clinical trial was
the proportion of patients who were completely clear of warts that
were present at baseline at or before week 12. In the
intent-to-treat analysis, 33% of patients achieved complete
clearance of all warts by week 12 when treated with SB206 12%
once-daily, compared to only 4% of patients achieving complete
clearance with vehicle once-daily (p=0.0099). In the per-protocol
analysis containing patients who completed a full 12 weeks of
dosing, 42% of patients achieved complete clearance of all warts
when treated with SB206 12% once-daily, compared to only 7% of
patients achieving complete clearance with vehicle once-daily
(p=0.0200).
The cutaneous tolerability of SB206 was
carefully monitored and recorded using scores on a four-point
grading scale for erythema, edema, erosions or ulcers and burning
or stinging. The once-daily treatment arms were generally well
tolerated, including the most effective dose, 12% once-daily. The
most frequently reported treatment-emergent adverse events were
application site reactions, the percentage of which was highest in
patients treated with SB206 4% twice-daily. Based on the local
application site adverse-event profile and the Company’s strict,
pre-specified stopping criteria, SB206 4% twice-daily was
discontinued, and all of the remaining cohorts were dosed
once-daily.
“I am honored to be part of the SB206
investigative team, and it was exciting to observe the clinical
benefits that a number of my patients experienced during the Phase
2 trial,” said Dr. Valentin Almendarez, Jr., board-certified
obstetrician and gynecologist at the Institute For Women’s Health
in San Antonio. “I believe that Novan’s topical nitric
oxide-releasing gel, SB206, could be a valuable treatment
alternative to existing prescription therapies and locally
destructive procedures, with a mechanism of action that would be
truly groundbreaking for the treatment of viral infections if
approved.”
“Our SB206 development program now includes in
vitro evidence against high-risk HPV-18 in a human raft cell
culture model, in vivo data against papilloma virus in rabbits, and
clinical evidence from our Phase 2 trial against genital warts
commonly caused by HPV-6 and -11,” said Dr. M. Joyce Rico,
board-certified dermatologist and Chief Medical Officer of Novan.
“The ability to directly inhibit viral replication suggests that
our nitric oxide-releasing technology may demonstrate activity
against a broad spectrum of HPV strains, including high-risk
subtypes associated with cancers of the head, neck and cervix.”
Based on the data generated in this Phase 2
dose-ranging trial, Novan expects to discuss the entirety of the
SB206 development program with the U.S. Food and Drug
Administration, or FDA, in the first half of 2017 and, assuming a
successful end-of-Phase 2 meeting with the FDA, plans to initiate
the Company’s late-stage program with Phase 3 pivotal clinical
trials of SB206 in the second half of 2017.
About Human Papillomavirus (HPV) and
Genital Warts
HPV refers to a large family of double-stranded
DNA viruses that induce abnormal growths on the skin or mucosal
surfaces. HPV affects nearly 80 million Americans, and an estimated
14 million new cases of the virus are reported each year, according
to the Centers for Disease Control and Prevention, or CDC. There
are over 100 subtypes of the virus, characterized as low-risk or
high-risk based on their cancer-causing potential. The virus is
typically transmitted via direct skin-to-skin contact through
disruptions in the normal skin barrier. All warts are caused by
HPV, including genital and perianal warts, common warts and plantar
warts.
Genital warts are among the world’s most common
sexually transmitted diseases. Genital warts are usually
flesh-colored growths that can be raised, flat or
cauliflower-shaped and are typically found on the surface of the
external genitalia or in and around the anus. In males, they can
appear on the surface of the penis and scrotum, and in females
inside the vagina or on the cervix. Genital warts carry a
substantial psychosocial burden due to the shame and embarrassment
related to having a sexually transmitted disease as well as the
inconvenience and discomfort of current treatment modalities.
Current treatment options for genital warts consist of ablative
procedures that cut, burn or freeze the warts but do not address
the underlying viral infection, and there are no currently approved
oral or topical prescription products indicated for the treatment
of genital warts with a direct anti-viral mechanism of action.
About Novan
Novan, Inc. is a late-stage pharmaceutical
company focused on redefining the standard of care in dermatology
through the development and commercialization of innovative
therapies using the Company’s nitric oxide-releasing platform.
Nitric oxide plays a vital role in the natural immune system
response against microbial pathogens and is a critical regulator of
inflammation. Our ability to harness nitric oxide and its multiple
mechanisms of action has enabled us to create a platform with the
potential to generate differentiated, first-in-class product
candidates. We are rapidly advancing programs in five
dermatological conditions with significant unmet medical need. We
believe that our ability to conveniently deploy nitric oxide on
demand in topical formulations allows us the potential to
significantly improve patient outcomes in a variety of skin
diseases and positions us to be a commercially successful leader in
the dermatology market.
For more information, visit the Company’s
website at www.Novan.com.
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 future prospects. 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, uncertainties and risks in the
clinical development process, including, among others, length,
expense, ability to enroll patients, reliance on third parties, and
that results of earlier research and preclinical or clinical trials
may not be predictive of results, conclusions or interpretations of
later research or trials; whether we will be able to obtain
additional funding when needed; and other risks and uncertainties
described in our prospectus dated Sept. 20, 2016, filed with the
Securities and Exchange Commission (the “SEC”), in our quarterly
report filed with the SEC on Form 10-Q for the three months ended
Sept. 30, 2016, and in any 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.
CONTACT:
(Investors)
Sean Andrews, Senior Director of Investor Relations
Novan, Inc.
919-627-6847
investors@novan.com
(Media)
Deb Holliday
Pascale Communications, LLC
412-877-4519
deb@pascalecommunications.com
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