Novus Therapeutics Receives FDA Guidance on OP0201 Phase 2a Study in Patients with Chronic Otitis Media with Effusion

Novus Therapeutics, Inc. NVUS, a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat (ENT), today announced that the U.S. Food and Drug Administration (FDA) has agreed with the Company's proposed patient population, endpoints, and statistical analysis plan for a phase 2a study of OP0201 in patients with chronic otitis media with effusion (COME) (study C-009). The FDA's feedback on the study C-009 was detailed in the minutes from a Type C meeting held with the Company's management team on September 20, 2019.

Study C-009 is designed to explore the effect of daily administration of OP0201 in patients with COME, a non-infectious form of otitis media. The study will enroll infants and children with three months or longer of bilateral middle ear effusion and hearing loss. The primary endpoints of study C-009 will be the resolution of middle ear effusion and/or restoration of hearing.

"We are pleased to have alignment with the FDA on our planned Phase 2a chronic otitis media with effusion study," said Dr. Catherine C. Turkel, President of Novus Therapeutics, Inc. "Persistent middle ear effusion and associated hearing loss is problematic, particularly for young patients in their developmental years. To date, no drug product has been approved for the treatment of this condition and surgery to insert tympanostomy tubes to clear the middle ear effusion is the only option for these patients. We look forward to studying OP0201 in this population."

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

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