29 November 2018 - - US-based specialty pharmaceutical company Novus Therapeutics, Inc. (NASDAQ: NVUS) 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 company said.

Study OP0201-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 randomised, 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.

OP0201 is being developed as a potential first-in-class treatment option for otitis media, which is often caused by Eustachian tube dysfunction.

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 and is intended to be used to restore the normal physiologic activity of the Eustachian tube, 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.

Novus Therapeutics is a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat.