IRVINE, Calif.–(BUSINESS WIRE)–$NVUS #ISOM–Novus Therapeutics, Inc. (NASDAQ: NVUS), a specialty pharmaceutical
company focused on developing products for patients with disorders of
the ear, nose, and throat (ENT), today announced that data from OP0201
study C-002 will be presented during the 20th International Symposium on
Recent Advances in Otitis Media, being held June 9-13, 2019 in Los
Angeles, CA.
-
Poster Title: A Phase 1 Safety Study
of Repeated Doses of Intranasal OP0201 Metered Dose Inhaler Compared
to Placebo in Healthy Adults: A Potential Treatment for Otitis Media -
Date/Time: Tuesday June 11, 2019 from
1:00 – 3:00 PM -
Location: Loews Hollywood Hotel, Los
Angeles, California
About Study C-002
Study C-002 was a phase 1 randomized, double-blind, placebo-controlled,
parallel-group, dose-escalation clinical trial designed to evaluate
safety and tolerability of 14 days of daily intranasal OP0201 (30 mg per
day or 60 mg per day) compared to placebo in 30 healthy adults. The
study was conducted at a single phase 1 unit in the United States.
Additional information about study C-002 can be found at clinicaltrials.gov
using the identifier NCT03748758 and at novustherapeutics.com.
About Novus Therapeutics
Novus Therapeutics, Inc. (Novus) is a specialty pharmaceutical company
focused on developing products for patients with disorders of the ear,
nose, and throat (ENT). The Company has two platform technologies, each
with the potential to be developed for multiple indications. Novus’ lead
program (OP0201) is a surfactant-based nasal aerosol drug-device
combination product candidate being developed as a potential
first-in-class treatment option for patients at risk for, or with,
otitis media (OM), which is middle ear inflammation and effusion with or
without infection. Globally, OM affects more than 700 million adults and
children every year, with over half of the cases occurring in children
under five years of age. OM is one of the most common disorders seen in
pediatric practice, and in the U.S. is a leading cause of health care
visits and the most frequent reason children are prescribed antibiotics
or undergo surgery. Novus also has a foam-based drug delivery technology
platform (OP01xx), 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
This press release contains forward‐looking statements that involves
substantial risks and uncertainties. Any statements about the company’s
future expectations, plans and prospects, including statements about its
strategy, future operations, development of its product candidates, and
other statements containing the words “believes,” “anticipates,”
“plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,”
“targets,” “looks forward,” “could,” “may,” and similar expressions,
constitute forward‐looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, although not all
forward‐looking statements include such identifying words.
Forward‐looking statements include, but are not limited to statements
regarding: risks related to market conditions, the completion of the
common stock and warrant financing, including the satisfaction of the
closing conditions, and the use of anticipated proceeds; expectations
regarding the timing for the commencement and completion of product
development or clinical trials, including the four ongoing OP0201
clinical trials; expectations regarding the success of clinical trials;
the rate and degree of market acceptance and clinical utility of the
company’s products; the company’s commercialization, marketing and
manufacturing capabilities and strategy; the company’s intellectual
property position and strategy; the company’s ability to identify
additional products or product candidates with significant commercial
potential; the company’s estimates regarding expenses, future revenue,
capital requirements and needs for additional financing; developments
relating to the company’s competitors and industry; and the impact of
government laws and regulations. Actual results may differ materially
from those indicated by such forward‐looking statements as a result of
various important factors, including: the ability to develop
commercially viable product formulations; the sufficiency of the
company’s cash resources; the ability to obtain necessary regulatory and
ethics 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; whether 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, whether it will be
successfully distributed and marketed. These risks and uncertainties, as
well as other risks and uncertainties that could cause the company’s
actual results to differ significantly from the forward‐looking
statements contained herein, are discussed in our quarterly, annual, and
other filings with the SEC, which can be found at www.sec.gov.
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.
Contacts
Investor Contacts
Timothy McCarthy
LifeSci Advisors, LLC
Tel:
212-915-2564
tim@lifesciadvisors.com