A bulging tympanic membrane which is typical in a case of acute otitis media. Credit: B. Welleschik.

Novus Therapeutics has dosed the first adult subjects in a Phase I clinical trial designed to evaluate the safety and tolerability of OP0201, developed to treat otitis media caused by Eustachian tube (ET) dysfunction.

In the low dose cohort of the OP0201-C-002 clinical trial, the safety of daily intranasal administration of the OP0201 product candidate will be evaluated over 14 consecutive days in 30 healthy adults.

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The randomised, double-blind, placebo-controlled, parallel-group, dose-escalation trial will include a 30mg per day (Cohort A) and 60mg per day (Cohort B) dose of the candidate.

The single-centre study will be conducted in the US.

“Completion of this safety study will position us to quickly move forward and evaluate OP0201 in children with otitis media.”

Novus Therapeutics president Dr Catherine Turkel said: “The initiation of this Phase I 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.

“Otitis media affects millions of people around the world, particularly young children, and can become extremely burdensome to patients and their caregivers.

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“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.”

The drug-device combination product OP0201 consists of a formulation of a surfactant (dipalmitoylphosphatidylcholine) and a spreading agent (cholesteryl palmitate) suspended in propellant.

Using a pressurised metered-dose inhaler, the product is administered intranasally. It will be used to restore the normal physiologic activity of the small ET that connects the middle ear to the back of the nasopharynx.