Expanded Indications in Field of Virology
Build on SB206 Clinical Success Against Human
Papillomavirus
Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today
announced that it has completed a transaction with KNOW Bio, LLC
granting Novan exclusive worldwide rights for certain oncovirus
applications of nitric oxide-based products. An oncovirus is a
virus that causes cancer. The agreement allows Novan to expand its
viral platform by exploring nitric oxide’s antiviral activity
against neoplasias and carcinomas caused by high-risk human
papillomavirus (HPV). Novan intends to focus HPV-related
development on localized therapies to treat HPV-associated sexually
transmitted infections, including pre-cancerous lesions of the
cervix and anus.
The intellectual property rights also allow for
potential future translations of nitric oxide as a treatment for
rare and orphan diseases caused by other double stranded DNA
viruses including Kaposi’s sarcoma-associated herpesvirus (HHV-8)
and Merkel cell polyomavirus (MCV).
Strength of Data Against Papillomavirus Enables
Path Forward
Novan has demonstrated Phase 2, statistically
significant complete clearance rates of external genital warts
caused by HPV with product candidate SB206. Collaborators at the
University of Alabama at Birmingham previously presented
preclinical data at the 31st International Papillomavirus
Conference demonstrating the antiviral effects of Novan’s nitric
oxide-releasing drug candidates against the high-risk HPV-18
genotype and an inhibition of the E6 viral protein. The E6 protein
impedes the immune system’s ability to recognize HPV-infected cells
and disrupts the cells' ability to repair DNA damage and prevent
abnormal cellular replication. As a result, E6 is believed to be a
primary driver of HPV-related cancers and other abnormal
growths.
“Nitric oxide inhibits replication of the human
papillomavirus through a mechanism that potentially translates to
numerous HPV subtypes,” stated Dr. Nathan Stasko, President and
Chief Scientific Officer. “The cascade of preclinical and
clinical data generated with our nitric oxide-based product
candidates give us confidence to expand our focus beyond
dermatology, and towards nitric oxide-based treatments for
cancer.”
SB414 as a Potential Non-Steroidal Topical
Treatment for Inflammatory Skin Diseases
Novan also announced today that it has initiated
clinical development of the Company’s nitric oxide platform in the
field of immunology. The first patient has been dosed in a Phase 1b
clinical trial to evaluate topical product candidate SB414 cream
for the treatment of psoriasis. The purpose of the Phase 1b trial
is to evaluate safety and to assess target engagement through a
reduction of key pro-inflammatory biomarkers like interleukin-17,
or IL-17, before progressing to Phase 2 clinical trials. According
to a recent peer-reviewed article in the British Journal of
Dermatology, IL-17 is known to be or is likely to be related to the
mechanism and severity of a number of inflammatory skin disorders,
including psoriasis, acne, atopic dermatitis, rosacea and alopecia
areata.1 Earlier this year, Novan presented mechanistic evidence
for SB414, demonstrating a statistically significant reduction in
composite psoriasis scores and an inhibition of IL-17a and
IL-17f.
Top line results for the Phase 1b trial are
expected in the second quarter of 2018. Additionally, Novan
is targeting to begin a Phase 1b trial with SB414 in adults with
atopic dermatitis before year end with top line results expected in
the third quarter of 2018.
“The news announced today reflects our deepened
strategic focus in the areas of virology and immunology,” stated
Kelly Martin, Novan’s Interim Chief Executive Officer. “These
milestones illustrate the immense potential of our nitric oxide
platform and provide Novan broader opportunities to demonstrate the
healing power of nitric oxide. Perhaps more importantly,
these developments may lead to desirable, new treatment paradigms
for patients suffering from viral malignancies and inflammatory
skin diseases.”
Corporate Update Conference Call and Webcast
The Company will host a conference call today at
8:30 a.m. Eastern Time. The phone number to join the conference
call is +1 (844) 707-0661 (toll-free in the United States and
Canada) or +1 (703) 318-2240 (international). The conference ID for
the live call is 1458576. A live webcast will be accessible from
the Events page of the Company’s website at
http://Events.Novan.com.
About Human Papillomavirus
An oncovirus is a virus that causes cancer. Approximately 20% of
all human cancers, worldwide, are caused by oncoviruses.2 As an
example, 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.3 The
virus is typically transmitted via direct skin-to-skin contact
through disruptions in the normal skin barrier. There are over 100
subtypes of the virus, characterized as low-risk or high-risk based
on their cancer-causing potential. While low-risk variants of HPV
typically are associated with two types of papillomas – common
warts and genital warts – high-risk strains of the virus are
associated with cervical intraepithelial neoplasia (CIN) and
cervical cancers; high-grade anal intraepithelial neoplasia (HGAIN)
and anal cancer; and, other cancers of the vagina, vulva, rectum
and penis. High risk strains 16 and 18 cause approximately 60% of
all oropharyngeal cancers and 70% of cervical cancers.4
About Psoriasis
Psoriasis is a chronic inflammatory skin disease
that affects approximately 7.5 million people in the United
States.5 The disease is characterized by an errant immune-system
response that drives inflammation and thickening of the skin caused
by rapid turnover of skin cells. This typically results in patches
of plaques, or thick, red raised skin with silvery-white scales.6,7
Psoriasis can cause tremendous discomfort and can interfere with
normal daily activities.5 It has also been associated with
increased incidence of a number of other diseases5 as well as
significant psychological and emotional effect, including social
isolation, depression and suicide.5,6 In fact, as many as 50% of
psoriasis patients may experience depression.5
There is no cure for psoriasis.7 The healthcare
market has seen an increase in the introduction of systemic
therapies, including biologics, to treat patients with higher
disease burden, but all of the current systemic therapies are
indicated only for patients with moderate-to-severe disease. For
the approximately 80% of patients with mild-to-moderate psoriasis,
prescription treatment options include topical corticosteroids,
retinoids and vitamin D3.5,6 None of the currently approved
therapies are without side effects, and none are well-suited for
chronic use.6,7
About Novan
Novan, Inc. is a clinical-stage biotechnology
company aiming to leverage 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, including our interpretation of preclinical studies and
the expected success and timing of our product development
activities and clinical trials, and the future prospects of our
business. 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 outcomes of our current
clinical trials and future preclinical studies and clinical trials,
including the timing of initiation of such trials and availability
of data from such trials, 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 Securities and Exchange Commission, or
SEC, on Form 10-K for the twelve months ended Dec. 31, 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. References
1 Speeckaert R, Lambert J, Grine L, Van Gele M, De Schepper S, van
Geel N. The many faces of interleukin-17 in inflammatory skin
diseases. Br J Dermatol. 2016 Nov; 175(5):892-901. 2 Mamo L,
Epstein S. The new sexual politics of cancer: Oncoviruses, disease
prevention, and sexual health promotion. BioSocieties. 2016
May;12:367-391.3 Center for Disease Control and Prevention. “Human
Papillomavirus: Questions and Answers.”
https://www.cdc.gov/hpv/parents/questions-answers.html (November
28, 2016)4 Center for Disease Control and Prevention. “HPV and
Oropharyngeal
Cancer.” https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm.
(July 17, 2017) 5 American Academy of Dermatology . "Psoriasis."
https://www.aad.org/media/stats/conditions/psoriasis (Nov. 15,
2016) 6 National Institutes of Health. "Questions and Answers about
Psoriasis." 7 Vaidya T, Feldman SR, Kirk J. Patient-centered
approach to biologics in the treatment of psoriasis. Journal of
Nature and Science. 2015 Mar;1 (3):e53.
CONTACT:
(Investors)Novan, Inc.919-627-6847investors@novan.com
(Media)Deb HollidayPascale Communications,
LLC412-877-4519deb@pascalecommunications.com
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