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