Clinical trial news : Novus Therapeutics has initiated a phase 1 pharmacodynamics clinical trial of its lead candidate OP0201 for the treatment of otitis media, an infection that affects the middle ear.
The California-based specialty pharma company, which is focused on developing drugs for ENT disorders, has dosed the first adult patients in the early-stage clinical trial called OP0201-C-001 (C-001), which is being held in Germany.
Otitis media is a group of inflammatory diseases occurring in the middle ear, which is caused frequently by Eustachian tube dysfunction (ETD).
OP0201 is a drug-device combination product, made up of a formulation of dipalmitoylphosphatidylcholine (DPPC), which is a surfactant and cholesteryl palmitate (CP), a spreading agent. The formulation, which is suspended in propellant, is intranasally administered through a pressurized metered-dose inhaler (pMDI) and has been designed to be used to restore the normal physiologic activity of the Eustachian tube (ET) – a small tube connecting the middle ear to the back of the nasopharynx.
The C-001 clinical trial aims to assess the safety, tolerability, and Eustachian tube function after a single intranasal dose of OP0201 in 16 healthy adults.
The early-stage clinical trial will evaluate the effect of a 20 mg dose of OP0201 on Eustachian tube function, which will be recorded through continuous tympanic impedance while enrolled participants are exposed to variaitons in atmospheric pressure produced in a hyperbaric/hypobaric chamber.
Dr. Catherine Turkel – President of Novus Therapeutics, commenting on the C-001 clinical trial of OP0201 in otitis media, said: “In addition to collecting additional safety information, this study aims to explore the potential effect of OP0201 on Eustachian tube function as subjects are exposed to changes in atmospheric pressure. We look forward to sharing the results from this study later this year.”
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