IRVINE, Calif.--(BUSINESS WIRE)--Jun. 19, 2018--
Novus Therapeutics, Inc. (NASDAQ: NVUS), a specialty pharmaceutical
company focused on developing products for patients with disorders of
the ear, nose, and throat (ENT), announced receipt of final meeting
minutes from the U.S. Food and Drug Administration (FDA) following a
Type C meeting held at the Company’s request to discuss its OP-02
development program in otitis media.
“The FDA provided guidance on our planned 505(b)(2) development path for
OP-02 and confirmed that no additional preclinical or clinical studies
beyond our planned phase 1 safety study in healthy adults will be
required before initiation of phase 2 studies in children 6-months of
age or older with otitis media,” said Dr. Catherine C. Turkel, President
of Novus Therapeutics, Inc.
“In addition, the FDA confirmed that development of OP-02 for separate
otitis media treatment and prevention indications is acceptable and
provided us with initial guidance on study design for these indications.
We look forward to working with the FDA as we continue to develop OP-02
as a potential first-in-class treatment option for the millions of
patients burdened by otitis media,” concluded Dr. Turkel.
About OP-02
OP-02 is a drug-device combination product comprised of a novel
formulation of the surfactant dipalmitoylphosphatidylcholine (DPPC) and
the spreading agent cholesteryl palmitate (CP) suspended in a
propellant. The product is administered intranasally via a metered dose
inhaler and is intended to be used to restore the normal physiologic
activity of the Eustachian tube (ET). Together DPPC and CP effectively
absorb to the air-liquid interface of the mucosa and reduce the
interfacial surface tension of the ET, which reduces passive pressure
required for the ET to open. In other words, OP-02 promotes
“de-sticking” of the ET so that ventilation and drainage of the middle
ear may occur.
About Novus Therapeutics
Novus Therapeutics is a specialty pharmaceutical company focused on
developing products for disorders of the ear, nose, and throat (ENT).
Novus has two technologies, each that has the potential to be developed
for multiple ENT indications. The company’s lead product (OP-02) is a
surfactant-based, combination drug product being developed as a
potential first-in-class treatment option for patients at risk for or
with otitis media (“OM”) (middle ear inflammation with or without
infection). Globally, OM affects more than 700 million adults and
children every year. OM is a common disorder seen in pediatric practice,
and in the United States is the most frequent reason children are
prescribed antibiotics and undergo surgery. Novus also has a foam-based
drug delivery technology (OP-01), which may be developed in the future
to deliver drugs into the ear, nasal, and sinus cavities. For more
information please visit novustherapeutics.com.
Forward-Looking Statements
Any statements in this press release about the company’s future
expectations, plans and prospects, including statements about its
strategy, future operations, development of its product candidates, the
review of strategic alternatives and the outcome of such review and
other statements containing the words “believes,” “anticipates,”
“plans,” “expects,” “may,” and similar expressions, constitute
forward-looking statements within the meaning of The Private Securities
Litigation Reform Act of 1995. Forward-looking statements include, but
are not limited to, expectations regarding the timing for the
commencement and completion of our clinical trials, manufacture drug
product and our ability to accelerate the development of our drug
candidates. Actual results may differ materially from those indicated by
such forward-looking statements as a result of various important
factors, including: the sufficiency of the company’s cash resources; the
ability to timely develop and manufacture clinical batches of our study
drugs; the ability to obtain necessary approvals to commence additional
clinical trials; whether data from early clinical trials will be
indicative of the data that will be obtained from future clinical
trials; whether the results of clinical trials will warrant submission
for regulatory approval of any investigational product, any such
submission will receive approval from the United States Food and Drug
Administration or equivalent foreign regulatory agencies and, if we are
able to obtain such approval for an investigational product, it will be
successfully distributed and marketed. Any forward-looking statements
contained in this press release speak only as of the date hereof and not
of any future date, and the company expressly disclaims any intent to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180619005550/en/
Source: Novus Therapeutics, Inc.
LifeSci Advisors, LLC
Timothy McCarthy, (212) 915-2564
tim@lifesciadvisors.com