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.

News Release

June 10, 2019 at 8:30 AM EDT

IRVINE, Calif.–(BUSINESS WIRE)–Jun. 10, 2019– 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.

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Source: Novus Therapeutics, Inc.

Investor Contacts
Timothy McCarthy
LifeSci Advisors, LLC
Tel: 212-915-2564
[email protected]