Pharmaceutical company Novus Therapeutics Inc (NASDAQ:NVUS) reported on Tuesday the start of treatment of the first adult subjects under the low dose cohort of a phase 1 clinical trial of its lead product candidate OP0201-C-002 (C-002) for the treatment of otitis media (OM) .

A middle ear inflammation with or without infection, OM is often caused by Eustachian tube dysfunction (ETD) and affects 700 million adults and children every year in the US, with over half of the cases occurring in children under five years of age.

According to the company, 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. It is administered intranasally and is intended to restore the normal physiologic activity of the Eustachian tube (ET). The DPPC and CP will absorb to the air-liquid interface of the mucosa and reduce the interfacial surface tension of the ET.

This C-002 is a phase 1 clinical trial is designed to evaluate safety and tolerability of daily intranasal administration of th ecompany's 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 centre study will be conducted in the US.