OP0201 Was Safe and Well-Tolerated in Healthy Adults and Adults
with Acute Otitis Media
IRVINE, Calif.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/search?q=%24NVUS&src=ctag” target=”_blank”gt;$NVUSlt;/agt; lt;a href=”https://twitter.com/hashtag/otitismedia?src=hash” target=”_blank”gt;#otitismedialt;/agt;–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 results from two OP0201
single-dose phase 1 clinical trials. The primary objective of
establishing safety and tolerability was achieved in both healthy adults
(study C-001) and in adults with acute otitis media (study C-004).
“We are delighted that results from single-dose phase 1 studies met the
primary objectives and demonstrated a favorable safety and tolerability
profile,” said Dr. Catherine Turkel, President of Novus Therapeutics,
“The safety profile of OP0201 was similar to placebo, and also similar
when administered to healthy adults or adults with acute otitis media.
Study participants did not report any adverse effect as it relates to
taste or smell after exposure to OP0201. In study C-001, we did not
observe any adverse effect on Eustachian tube function. In study C-004,
the majority of the participants in both treatment groups reported
relief of ear pain, although no treatment difference was observed
between the treatment groups.”
Study C-001 was a randomized, double-blind, cross-over, single-dose
phase 1 trial in healthy adults designed to evaluate safety,
tolerability, and explore Eustachian tube function within a 150-minute
period following a single 20 mg intranasal dose of OP0201 or placebo
while participants were exposed to changes in pressure induced by a
6-minute hyperbaric/hypobaric protocol in an atmospheric pressure
chamber.
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- The mean age of the 17 participants was 25.8 years, 52.9% were female
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- In total, 76.5% (13/17) of participants who received OP0201 and 81.3%
(13/16) of participants who received placebo experienced one or more
adverse events
- In total, 76.5% (13/17) of participants who received OP0201 and 81.3%
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- The most common OP0201 adverse events occurring in more than 2
participants and greater than placebo were tympanic membrane hyperemia
and tympanic membrane disorder. These events were attributed by the
ENT physician investigator to be related to the pressure chamber and
not deemed related to OP0201 or placebo
- The most common OP0201 adverse events occurring in more than 2
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- No serious adverse events occurred during the study
Study C-004 was a randomized, double-blind, placebo-controlled,
parallel-group phase 1 trial in adults with acute otitis media and
moderate or worse ear pain designed to evaluate safety, tolerability,
and explore relief of ear pain within a 60-minute period following a
single 20 mg intranasal dose of OP0201 or placebo.
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- The mean age of the 24 participants was 49.5 years, 66.7% were female
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- In total, 16.7% (2/12) of participants who received OP0201 and 50.0%
(6/12) of participants who received placebo experienced one or more
adverse events. The two adverse events reported in the two
participants who received OP0201 were mild nasal discomfort and mild
lacrimation increase. Both adverse events were mild and resolved
- In total, 16.7% (2/12) of participants who received OP0201 and 50.0%
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- No serious adverse events occurred during the study
“We have also recently completed our multiple-dose phase 1 safety trial,
and in the coming months we will report data from the 14-day,
dose-escalation safety and tolerability study in healthy adults.
Further, this past February we initiated our phase 2a pediatric otitis
media development program which is ongoing, and by year end we will have
our first look at safety, tolerability and efficacy with 10 days of
OP0201 treatment compared to placebo in infants and children with acute
otitis media,” concluded Dr. Turkel.
Study C-002 is a phase 1 clinical trial designed to evaluate safety and
tolerability of twice daily intranasal administration of OP0201 over 14
consecutive days in 30 healthy adults. The randomized, double-blind,
placebo-controlled, parallel-group, dose-escalation trial includes a 30
mg per day dose (Cohort A) and 60 mg per day dose (Cohort B) of OP0201.
Study C-006 is an exploratory phase 2a clinical trial designed to
evaluate safety, tolerability, and efficacy of twice daily intranasal
administration of OP0201 over 10 consecutive days in infants and
children 6 to 24 months of age with acute otitis media. The randomized,
double-blind, placebo-controlled, parallel-group trial explores the
effects of a 20 mg per day dose of OP0201 as an adjunct to oral
antibiotics. Patients will be followed for up to 30 days, during which
multiple efficacy endpoints will be explored.
About OP0201
OP0201 is being developed as a potential first-in-class treatment option
for OM. OM is often caused by Eustachian tube dysfunction (ETD). OP0201
is a nasal aerosol, drug-device combination product comprised of a novel
formulation of a surfactant (dipalmitoylphosphatidylcholine [DPPC]) and
a spreading agent (cholesteryl palmitate [CP]) suspended in propellant.
The product is administered intranasally via a pressurized metered-dose
inhaler (pMDI). OP0201 is intended to be used to restore the normal
physiologic activity of the ET, which is a small tube that connects the
middle ear cavity to the back of the nasopharynx. Together, the active
ingredients in OP0201 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,
OP0201 is intended to promote ‘de-sticking’ of the ET so that
ventilation of the middle ear may occur.
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,”
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“targets,” “looks forward,” “could,” “may,” and similar expressions,
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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: 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
tim@lifesciadvisors.com
Tel:
(212) 915-2564