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

Novus Therapeutics has commenced dosing in a Phase IIa clinical trial of OP0201 for the treatment of otitis media, an inflammatory disease affecting the middle ear.

OP0201 is a drug-device combination that consists of a formulation of surfactant dipalmitoylphosphatidylcholine and a spreading agent called cholesteryl palmitate, suspended in a propellant.

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The drug is administered intranasally using a pressurised metered-dose inhaler (pMDI). It is meant to restore the normal physiologic activity of the Eustachian tube (ET), which connects the middle ear to the back of the nasopharynx.

The exploratory Phase IIa trial, named OP0201-C-006, is intended to assess the safety, tolerability, and efficacy of a daily 20mg dose of OP0201 as an adjunct to oral antibiotics over ten consecutive days.

“This exploratory Phase IIa study will help us to better understand the potential benefits of OP0201 when used as an adjunct to oral antibiotics.”

OP0201-C-006 is a randomised, double-blind, placebo-controlled, parallel-group trial will be conducted in 50 paediatric patients aged 6-24 months at a single site in the US.

Novus Therapeutics president Catherine Turkel said: “Acute otitis media affects millions of people every year, particularly young children who account for more than half of the incident cases annually.

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“This exploratory Phase IIa study will help us to better understand the potential benefits of OP0201 when used as an adjunct to oral antibiotics, as well as help us plan our future otitis media clinical trials.”

Primary outcome measures of the trial are an evaluation of safety in the form of adverse effects, as well as efficacy measured as otoscopy.

The study will also monitor secondary outcome measures such as proportion of patients with no middle ear effusion, and those with abnormal tympanogram.

Novus Therapeutics anticipates completing the trial by April this year.