Novus Therapeutics Doses First Subjects in Phase 1 Pharmacodynamics Study of OP0201
Dr.
Study OP0201-C-001 (“C-001”) is a phase 1 clinical trial designed to
evaluate safety, tolerability, and Eustachian tube (“ET”) function
following a single intranasal dose of OP0201 in 16 healthy adults. The
randomized, double-blind, placebo-controlled, cross-over trial will
explore the effect of a 20 mg dose of OP0201 on ET function. Assessment
of ET function will be captured using continuous tympanic impedance
while subjects are exposed to changes in atmospheric pressure produced
in a hyperbaric/hypobaric chamber. 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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LifeSci Advisors, LLC
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