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Novus Therapeutics Advances OP0201 Development Program Across Several Clinical Trials

Wednesday, January 30th 2019 at 1:00pm UTC

Screening Initiated for Phase 1 Pharmacodynamic Effects Trial
(Study C-001)

Screening Initiated for Second Cohort of Phase 1 Trial in Healthy
Adults (Study C-002)

Enrollment Completed in Phase 1 Trial in Adults with Acute Otitis
Media (Study C-004)

New Phase 2a Trial in Infants and Children with Acute Otitis Media
Planned for 2019 (Study C-006)

IRVINE, Calif.–(BUSINESS WIRE)– 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 provided updates on several
ongoing and planned clinical trials with OP0201, the company’s lead
product candidate being developed for otitis media.

“We have made good progress with the OP0201 development program over the
past few months and we are looking forward to reporting data from four
clinical trials this year,” said Gregory J. Flesher, CEO of Novus
Therapeutics. “We initiated screening for study C-001, a single-dose
phase 1 safety and pharmacodynamic effects study. We completed the first
dose cohort of study C-002, the ongoing 14-day phase 1 adult safety and
tolerability study, and have initiated screening for the second higher
dose cohort. We expect data from these two clinical trials to be
available in the second calendar quarter of 2019. In addition, we
recently completed enrollment of study C-004, the single-dose phase 1
safety and exploration of efficacy study in adults with acute otitis
media. Given the rapid enrollment of study C-004, we now expect to have
data by the end of the first calendar quarter of 2019.”

“Finally, we are pleased to announce the addition of study C-006, an
exploratory phase 2a placebo-controlled study in infants and children
with acute otitis media. This trial replaces the previously announced
phase 1 open-label study in children with otitis media with effusion.
This new phase 2a study is designed to explore multiple endpoints and
help the company design larger phase 2 studies in patients. We expect
enrollment of this trial to begin in the coming weeks, with data
available in the second half of 2019,” concluded Mr. Flesher.

Study OP0201-C-001 (“C-001”)

Study C-001 is a phase 1 clinical trial designed to evaluate safety,
tolerability, and Eustachian tube (“ET”) function following a single
intranasal dose of OP0201 in 16 healthy adults. The randomized,
double-blind, placebo-controlled, cross-over trial will explore the
effect of a 20 mg dose of OP0201 on ET function. Assessment of ET
function will be captured using continuous tympanic impedance while
subjects are exposed to changes in atmospheric pressure produced in a
hyperbaric/hypobaric chamber. The single center study will be conducted
in Germany.

Study OP0201-C-002 (“C-002”)

Study C-002 is a phase 1 clinical trial designed to evaluate safety and
tolerability of 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.
The study is being conducted at a single phase 1 unit in the United
States. Additional information about the study can be found at
clinicaltrials.gov using the identifier NCT03748758.

Study OP0201-C-004 (“C-004”)

Study C-004 is a phase 1 clinical trial designed to evaluate safety,
tolerability, and relief of ear pain over a 60-minute observation period
following a single intranasal dose of OP0201 in 24 adults with acute
otitis media. The randomized, double-blind, placebo-controlled,
parallel-group trial will explore the effects of a 20 mg intranasal dose
of OP0201. Assessment of pain relief will be captured utilizing a Visual
Analog Scale (VAS), Numeric Rating Scale (NRS-11), Patient Global
Impression of Change (PGIC), and Clinical Global Impressions Scale:
Global Improvement (CGI-I). The multicenter study was conducted in the
United States. Additional information about the study can be found at
clinicaltrials.gov using the identifier NCT03766373.

Study OP0201-C-006 (“C-006”)

Study C-006 is an exploratory phase 2a clinical trial designed to
evaluate safety, tolerability, and efficacy of daily intranasal
administration of OP0201 over 10 consecutive days in 50 pediatric
patients, 6 to 24 months of age, with acute otitis media. The
randomized, double-blind, placebo-controlled, parallel-group trial will
explore the effects of a 20 mg per day dose of OP0201 as an adjunct to
oral antibiotics. Patients will receive 10 days of treatment and will be
followed for up to 30 days, during which multiple endpoints will be
explored. The single center study will be conducted in the United
States. Additional information about the study can be found at
clinicaltrials.gov using the identifier NCT03818815.

About OP0201

OP0201 is being developed as a potential first-in-class treatment option
for otitis media (“OM”), which is often caused by Eustachian tube
dysfunction (“ETD”). OP0201 is a drug-device combination product
comprised of a proprietary formulation of a surfactant
(dipalmitoylphosphatidylcholine or “DPPC”) and a spreading agent
(cholesteryl palmitate or “CP”) suspended in propellant. The product is
administered intranasally via a pressurized metered-dose inhaler
(“pMDI”) and is intended to be used to restore the normal physiologic
activity of the Eustachian tube (“ET”), which is the small tube that
connects the middle ear to the back of the nasopharynx. Together DPPC
and CP are designed to effectively absorb to the air-liquid interface of
the mucosa and reduce the interfacial surface tension of the ET, which
reduces the 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”). Novus has two technologies, each that has the
potential to be developed for multiple ENT indications. Novus’ lead
product candidate (OP0201) is a surfactant-based, drug-device
combination product being developed as a potential first-in-class
treatment option for patients at risk for, or with, otitis media (“OM”
or middle ear inflammation 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
United States 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 (OP0102), 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,” “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: expectations
regarding the timing for the commencement and completion of product
development or 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 report on Form 10?Q for the quarter ended September 30, 2018,
as well as 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

Timothy McCarthy
LifeSci Advisors, LLC
tim@lifesciadvisors.com
Tel:
(212) 915-2564

Source: Novus Therapeutics, Inc.


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