Policy & Regulation
Novus Therapeutics Doses First Subjects in Phase 1 Pharmacodynamics Study of OP0201
11 February 2019 - - US-based specialty pharmaceutical company Novus Therapeutics, Inc. (NASDAQ: NVUS) has dosed the first adult subjects in study C-001, a phase 1 pharmacodynamics clinical trial of OP0201, the company's lead product candidate being developed for otitis media, the company said.

Study OP0201-C-001 is a phase 1 clinical trial designed to evaluate safety, tolerability, and Eustachian tube function following a single intranasal dose of OP0201 in 16 healthy adults.

The randomised, 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 centre study will be conducted in Germany. Additional information about the study can be found at clinicaltrials.gov using the identifier NCT03828149.

OP0201 is being developed as a potential first-in-class treatment option for otitis media, which is often caused by Eustachian tube dysfunction.

OP0201 is a drug-device combination product comprised of a proprietary formulation of a surfactant and a spreading agent suspended in propellant.

The product is administered intranasally via a pressurised metered-dose inhaler and is intended to be used to restore the normal physiologic activity of the Eustachian tube, 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.

Novus Therapeutics, Inc. is a specialty pharmaceutical company focused on developing products for patients with disorders of the ear, nose, and throat.

Novus has two technologies, each that has the potential to be developed for multiple ENT indications. Novus' lead product candidate (OP0201) is a surfactant-based, drug-device combination product being developed as a potential first-in-class treatment option for patients at risk for, or with, otitis media.

Globally, OM affects more than 700 m adults and children every year, with over half of the cases occurring in children under five years of age.

OM is one of the most common disorders seen in pediatric practice, and in the United States is a leading cause of health care visits and the most frequent reason children are prescribed antibiotics or undergo surgery.

Novus also has a foam-based drug delivery technology (OP0102), which may be developed in the future to deliver drugs into the ear, nasal, and sinus cavities.
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