30 January 2019 - - US-based specialty pharmaceutical company Novus Therapeutics, Inc. (NASDAQ: NVUS) has provided updates on several ongoing and planned clinical trials with OP0201, the company's lead product candidate being developed for otitis media.

Study 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 center study will be conducted in Germany.

Study 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 randomised, double-blind, placebo-controlled, parallel-group, dose-escalation trial includes a 30 mg per day dose (Cohort A) and 60 mg per day dose (Cohort B) of OP0201. The study is being conducted at a single phase 1 unit in the United States.

Study C-004 is a phase 1 clinical trial designed to evaluate safety, tolerability, and relief of ear pain over a 60-minute observation period following a single intranasal dose of OP0201 in 24 adults with acute otitis media.

The randomised, double-blind, placebo-controlled, parallel-group trial will explore the effects of a 20 mg intranasal dose of OP0201.

Assessment of pain relief will be captured utilising a Visual Analog Scale, Numeric Rating Scale (NRS-11), Patient Global Impression of Change, and Clinical Global Impressions Scale: Global Improvement (CGI-I). The multicenter study was conducted in the United States.

Study 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 randomised, 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.

Patients will receive 10 days of treatment and will be followed for up to 30 days, during which multiple endpoints will be explored. The single center study will be conducted in the United States.

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 (dipalmitoylphosphatidylcholine or "DPPC") and a spreading agent (cholesteryl palmitate or "CP") 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 ("OM" or middle ear inflammation with or without infection).

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.