Novus Therapeutics Doses First Patients in Phase 2a Trial of OP0201
“We are pleased to be working with Dr.
Study OP0201-C-006 (“C-006”) is an exploratory phase 2a clinical trial
designed to evaluate safety, tolerability, and efficacy of daily
intranasal administration of OP0201 over 10 consecutive days in 50
pediatric patients, 6 to 24 months of age, with acute otitis media. The
randomized, double-blind, placebo-controlled, parallel-group trial will
explore the effects of a 20 mg per day dose of OP0201 as an adjunct to
oral antibiotics. The overall study duration is up to 30 days during
which patients will receive 10 days of treatment. Multiple safety and
efficacy endpoints will be explored. The single center study will be
conducted in
About OP0201
OP0201 is being developed as a potential first-in-class treatment option for otitis media (“OM”), which is often caused by Eustachian tube dysfunction (“ETD”). 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. The product is administered intranasally via a pressurized metered-dose inhaler (“pMDI”) and is intended to be used to restore the normal physiologic activity of the Eustachian tube (“ET”), which is the small tube that connects the middle ear to the back of the nasopharynx. Together DPPC and CP are designed to effectively absorb to the air-liquid interface of the mucosa and reduce the interfacial surface tension of the ET, which reduces the passive pressure required for the ET to open. In other words, OP0201 is intended to promote ‘de-sticking’ of the ET so that ventilation of the middle ear may occur.
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