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 adult subjects in the low dose cohort of a phase 1 clinical trial of OP0201, the company’s lead product candidate being developed for otitis media.
“The initiation of this phase 1 study represents a significant milestone for the company. Completion of this safety study will position us to quickly move forward and evaluate OP0201 in children with otitis media,” said Dr. Catherine Turkel, President of Novus Therapeutics. “Otitis media affects millions of people around the world, particularly young children, and can become extremely burdensome to patients and their caregivers. Given the lack of any approved pharmaceutical treatment options, OP0201 has the potential to be a transformational, first-in-class treatment option that addresses the underlying cause of otitis media.”
Study OP0201-C-002 (“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 will include a 30 mg per day (Cohort A) and 60 mg per day (Cohort B) dose of OP0201. The single center study will be conducted in the United States. Additional information about the study can be found at https://clinicaltrials.gov/ using the identifier NCT03748758.
“If ultimately approved by health authorities, OP0201 may fundamentally alter the current treatment paradigm for otitis media and provide a non-invasive alternative to surgical insertion of ventilation tubes into the tympanic membrane - commonly known as the eardrum,” concluded Dr. Turkel.
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.
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