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 The leading web portal for pharmacy resources, news, education and careers March 21, 2019
Pharmacy Choice - Pharmaceutical News - Novus Therapeutics Doses First Patients in Phase 2a Trial of OP0201 - March 21, 2019

Pharmacy News Article

 2/19/19 - Novus Therapeutics Doses First Patients in Phase 2a Trial of OP0201

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 announced that it has dosed the first patients in a phase 2a trial of OP0201, the company's lead product candidate being developed for otitis media.

We are pleased to be working with Dr. Alejandro Hoberman and the clinical research staff at the University of Pittsburgh on study C-006, said Dr. Catherine Turkel, President of Novus Therapeutics. Acute otitis media affects millions of people every year, particularly young children who account for more than half of the incident cases annually. This exploratory phase 2a study will help us to better understand the potential benefits of OP0201 when used as an adjunct to oral antibiotics, as well as help us plan our future otitis media clinical trials.

Study OP0201-C-006 (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. The overall study duration is up to 30 days during which patients will receive 10 days of treatment. Multiple safety and efficacy 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 forwardlooking 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 forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of 1995, although not all forwardlooking statements include such identifying words. Forwardlooking 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 forwardlooking 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 forwardlooking statements contained herein, are discussed in our quarterly report on Form 10Q for the quarter ended September 30, 2018, as well as other filings with the SEC which can be found at www.sec.gov. Any forwardlooking 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 forwardlooking statements, whether as a result of new information, future events or otherwise.

Investor Contacts

Timothy McCarthy

LifeSci Advisors, LLC

tim@lifesciadvisors.com

Tel: (212) 915-2564

Source: Novus Therapeutics, Inc.



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