Novus Therapeutics Doses First Patient with Acute Otitis Media in Phase 1 Study of OP0201

IRVINE, CA, USA I January 8, 2019 I 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 adult patient with acute otitis media in a phase 1 clinical trial of OP0201, the company’s lead product candidate being developed for otitis media.

“This phase 1 study will provide additional safety information in adults with acute otitis media and will help us better understand the onset of symptom relief following an initial dose of OP0201,” said Dr. Catherine Turkel, President of Novus Therapeutics.

Study OP0201-C-004 (“C-004”) is a phase 1 clinical trial designed to evaluate safety and relief of ear pain following a single intranasal dose of OP0201 over a 60-minute observation period 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 will be conducted in the United States. Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03766373.

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 and drainage 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 (OP01), which may be developed in the future to deliver drugs into the ear, nasal, and sinus cavities. For more information please visit novustherapeutics.com.

SOURCE: Novus Therapeutics

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