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

Novus Therapeutics has dosed the first patient in the Phase I OP0201-C-004 (C-004) clinical trial of OP0201 for the treatment of acute otitis media, a painful type of ear infection.

The randomised, double-blind trial is expected to investigate the safety and relief of ear pain following a single intranasal dose of 20mg OP0201 followed by a 60-minute observation period.

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It intends to enrol 24 adult patients with acute otitis media across various centres in the US.

“This Phase I study will provide additional safety information in adults with acute otitis media.”

The primary endpoint of the trial is safety while its secondary endpoints include a reduction of ear pain as measured by visual analog scale (VAS) and numeric rating scale (NRS-11), as well as a change in symptoms using patient global impression of change (PGIC).

Completion of the placebo-controlled, parallel-group trial is expected next month.

Novus Therapeutics president Dr Catherine Turkel said: “This Phase I study will provide additional safety information in adults with acute otitis media and will help us better understand the onset of symptom relief following an initial dose of OP0201.”

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The company is currently developing OP0201 as a potential treatment option for otitis media (OM), which is primarily caused by Eustachian tube dysfunction (ETD).

The drug-device combination product combines a surfactant (dipalmitoylphosphatidylcholine or DPPC) formulation with a spreading agent (cholesteryl palmitate or CP) suspended in a propellant.

OP0201 is also developed to support ‘de-sticking’ of the ET for ventilation and drainage of the middle ear.