Novus Therapeutics Doses First Subjects in Phase 1 Study of OP0201
“The initiation of this phase 1 study represents a significant milestone
for the company. Completion of this safety study will position us to
quickly move forward and evaluate OP0201 in children with otitis media,”
said Dr.
Study OP0201-C-002 (“C-002”) is a phase 1 clinical trial designed to
evaluate safety and tolerability of daily intranasal administration of
OP0201 over 14 consecutive days in 30 healthy adults. The randomized,
double-blind, placebo-controlled, parallel-group, dose-escalation trial
will include a 30 mg per day (Cohort A) and 60 mg per day (Cohort B)
dose of OP0201. The single center study will be conducted in
“If ultimately approved by health authorities, OP0201 may fundamentally alter the current treatment paradigm for otitis media and provide a non-invasive alternative to surgical insertion of ventilation tubes into the tympanic membrane - commonly known as the eardrum,” concluded Dr. Turkel.
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 and drainage of the middle ear may occur.
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