Novan, Inc. ("the Company" or "Novan") (NASDAQ:NOVN) today
announced that Phase 2 efficacy and safety data for SB208, a
topical, silicone-based gel under development for the treatment of
fungal infections of the skin and nails, such as tinea pedis, or
athlete’s foot, and onychomycosis, will be presented at the Winter
Clinical Dermatology Conference to be held January 12th through the
17th in Maui, Hawaii.
“Onychomycosis and tinea pedis are often
coexistent and persistent fungal infections, in part because there
are no currently-approved topical therapies that treat both with a
single product,” said Dr. Leon Kircik, board-certified
dermatologist, associate clinical professor of dermatology at
Indiana University Medical Center in Indianapolis and Icahn School
of Medicine at Mount Sinai Medical Center in New York and medical
director of DermResearch, PLLC and Physicians Skin Care, PLLC.
“Having a simple, effective, one-step treatment with a unique
mode-of-action would be a significant advancement in the real world
of treating these patients.”
Recent studies suggest that the nail plate,
interdigital space and surrounding tissue may serve as an
overlooked reservoir of dermatophytes, perpetuating reinfection and
coinfection of onychomycosis and tinea pedis.1 In preclinical
studies, Novan’s nitric oxide-based drug candidate exhibited a
greater than 99.9% fungal reduction of the dermatophyte
Trichophyton rubrum in vitro in as little as four hours, and in a
separate human nail penetration assay, killed greater than 90% of
fungus on the underside of the nail following a single topical
treatment. “The results from our Phase 2 dose ranging trial,
in combination with our existing preclinical antifungal data,
support the development of SB208 as a potential nitric oxide-based
solution for treating patients with multiple fungal infections,”
said Nathan Stasko, Ph.D., President and Chief Scientific Officer
of Novan.
In a Phase 2 double-blinded, randomized,
vehicle-controlled, dose-ranging clinical trial, the tolerability,
safety and antifungal activity of SB208 was evaluated in 222
patients with clinical signs and symptoms of tinea pedis, or
Athlete’s Foot. Patients were randomized evenly to one of three
active or vehicle treatment arms, applying either SB208 Gel (2%, 4%
or 16%) or vehicle once-daily for two weeks, followed by a
four-week post-treatment observation period.
Efficacy assessments were made on a modified
intent-to-treat population (mITT) comprised of patients who had a
positive baseline culture for dermatophytes such as T. rubrum.
- In the primary efficacy analysis of subjects with evaluable
culture results, 61.3% (p=0.209) of patients treated with SB208 2%,
80.6% (p=0.002) of patients treated with SB208 4% and 74.2%
(p=0.016) of patients treated with SB208 16% achieved negative
fungal culture at day 14 versus 45.5% of patients treated with
vehicle.
Mycological cure, defined as both a negative
fungal culture and a negative skin scraping for the presence of
fungus, was assessed at day 14 and after a four week follow up
period at day 42 as secondary efficacy endpoints.
- The percentage of patients achieving mycological cure at the
day 14 visit was 34.4% (p=0.305) of the patients treated with SB204
2%, 50.0% (p=0.009) of the patients treated with SB208 4% and 53.1%
(p=0.010) of patients treated with SB208 16% versus 23.5% of
patients treated with vehicle.
- At day 42, the highest mycological cure rates were observed in
58.8% of patients treated with SB208 16% (p=0.020 compared to
vehicle).
Clinical signs and symptoms of tinea pedis were
also evaluated on a four-point scale ranging from none to severe at
each assessment timepoint. Signs and symptoms included
erythema, scaling, maceration, cracking, pruritus and
burning/stinging. Efficacy measures of clinical cure were
defined as a sum of total signs/symptoms severity score of no more
than two with no individual symptom severity score greater than
one. The clinical cure response rates were greatest at day 42, 4
weeks after treatment, and the two highest SB208 dose groups (4 and
16%) were approximately two times higher than the response rate for
vehicle and SB208 2%.
- The percentage of patients achieving clinical cure at day 42
was 14.3% of the patients treated with SB208 2%, 29.7% of the
patients treated with SB208 4%, and 25.0% of patients treated with
SB208 16% versus 14.3% of patients treated with vehicle.
The overall incidence of adverse events was low
(9 subjects or 4%) and similar in all groups. None of the treatment
emergent adverse events were determined to be related to the study
medication, and no patients discontinued treatment or dropped out
of the study due to an adverse event.
Based on the positive data generated in this
SB208 Phase 2 dose-ranging trial, Novan intends to evaluate
potential partnerships to advance the antifungal candidate into
later stages of development.
About Onychomycosis
Onychomycosis is a chronic fungal infection of
the nails that affects approximately 40 million Americans and
accounts for one-third of cutaneous fungal infections. The
prevalence of disease increases with age, and more than 50% of
patients are 70 years or older. The infection, caused by
dermatophytes such as Trichophyton rubrum, often results in painful
thickening and deformation of the nail and sometimes the separation
of the nail plate from the nail bed, leading to an inability of the
nail to perform its natural protective function. Oral therapies
used to treat the infection are associated with severe side
effects, and topical therapies have modest efficacy profiles with
complete cure rates of less than 20%.
About Tinea Pedis
Tinea pedis, often referred to as Athlete’s
Foot, is a common fungal infection of the feet, affecting
approximately 75 million Americans. Trichophyton rubrum is the most
prominent dermatophyte in tinea pedis and also a causative pathogen
in onychomycosis. Approximately one-third of onychomycosis patients
also suffer from tinea pedis. Topical treatments are the first-line
therapy for tinea pedis, while oral antifungals are prescribed when
the infection is severe, or the use of topical antifungals is not
feasible. Currently, there is no approved single topical
therapeutic agent that provides for the simultaneous treatment of
the nail plate, bed, and surrounding cutaneous tissue.
About Novan
Novan, Inc. is a clinical-stage biotechnology
company focused on leveraging nitric oxide’s natural antiviral and
immunomodulatory mechanisms of action to treat dermatological and
oncovirus-mediated diseases. We believe that our ability to
conveniently deploy nitric oxide in a solid form, on demand and in
localized formulations allows us the potential to significantly
improve patient outcomes in a variety of diseases.
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, our potential partnership opportunities, and the future
prospects of our business and our product candidates.
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 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; the lengthy and
unpredictable nature of the U.S. Food and Drug Administration’s
drug approval process; whether we will be able to enter into
strategic arrangements or obtain adequate funding to support our
operations and initiatives on acceptable terms, or at all, and
other risks and uncertainties described in our annual report filed
with the SEC on Form 10-K for the twelve months ended Dec. 31,
2016, 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.
References
1Lipner SR, Scher RK. 2015. Management of
onychomycosis and co-existing tinea pedis. J Drugs Dermatol
14(5)492-94.2Markinson B, Caldwell B. 2015. Efinaconazole topical
solution, 10% efficacy in patients with onychomycosis and
coexisting tinea pedis. J Am Podiatr Med Assoc 105(5):407-11.
CONTACT:
(Investors)Novan, Inc.investors@novan.com
(Media)Cari GreenDirector, Corporate Communications and
Administrationcgreen@novan.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