Novus Therapeutics Announces Results of Two Single-Dose OP0201 Phase 1 Clinical Trials
OP0201 Was Safe and Well-Tolerated in Healthy Adults and Adults with Acute Otitis Media
“We are delighted that results from single-dose phase 1 studies met the
primary objectives and demonstrated a favorable safety and tolerability
profile,” said Dr.
Study C-001 was a randomized, double-blind, cross-over, single-dose phase 1 trial in healthy adults designed to evaluate safety, tolerability, and explore Eustachian tube function within a 150-minute period following a single 20 mg intranasal dose of OP0201 or placebo while participants were exposed to changes in pressure induced by a 6-minute hyperbaric/hypobaric protocol in an atmospheric pressure chamber.
- The mean age of the 17 participants was 25.8 years, 52.9% were female
- In total, 76.5% (13/17) of participants who received OP0201 and 81.3% (13/16) of participants who received placebo experienced one or more adverse events
- The most common OP0201 adverse events occurring in more than 2 participants and greater than placebo were tympanic membrane hyperemia and tympanic membrane disorder. These events were attributed by the ENT physician investigator to be related to the pressure chamber and not deemed related to OP0201 or placebo
- No serious adverse events occurred during the study
Study C-004 was a randomized, double-blind, placebo-controlled, parallel-group phase 1 trial in adults with acute otitis media and moderate or worse ear pain designed to evaluate safety, tolerability, and explore relief of ear pain within a 60-minute period following a single 20 mg intranasal dose of OP0201 or placebo.
- The mean age of the 24 participants was 49.5 years, 66.7% were female
- In total, 16.7% (2/12) of participants who received OP0201 and 50.0% (6/12) of participants who received placebo experienced one or more adverse events. The two adverse events reported in the two participants who received OP0201 were mild nasal discomfort and mild lacrimation increase. Both adverse events were mild and resolved
- No serious adverse events occurred during the study
“We have also recently completed our multiple-dose phase 1 safety trial, and in the coming months we will report data from the 14-day, dose-escalation safety and tolerability study in healthy adults. Further, this past February we initiated our phase 2a pediatric otitis media development program which is ongoing, and by year end we will have our first look at safety, tolerability and efficacy with 10 days of OP0201 treatment compared to placebo in infants and children with acute otitis media,” concluded Dr. Turkel.
Study C-002 is a phase 1 clinical trial designed to evaluate safety and tolerability of twice daily intranasal administration of OP0201 over 14 consecutive days in 30 healthy adults. The randomized, 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.
Study C-006 is an exploratory phase 2a clinical trial designed to evaluate safety, tolerability, and efficacy of twice daily intranasal administration of OP0201 over 10 consecutive days in infants and children 6 to 24 months of age with acute otitis media. The randomized, double-blind, placebo-controlled, parallel-group trial explores the effects of a 20 mg per day dose of OP0201 as an adjunct to oral antibiotics. Patients will be followed for up to 30 days, during which multiple efficacy endpoints will be explored.
OP0201 is being developed as a potential first-in-class treatment option for OM. OM is often caused by Eustachian tube dysfunction (ETD). OP0201 is a nasal aerosol, drug-device combination product comprised of a novel formulation of a surfactant (dipalmitoylphosphatidylcholine [DPPC]) and a spreading agent (cholesteryl palmitate [CP]) suspended in propellant. The product is administered intranasally via a pressurized metered-dose inhaler (pMDI). OP0201 is intended to be used to restore the normal physiologic activity of the ET, which is a small tube that connects the middle ear cavity to the back of the nasopharynx. Together, the active ingredients in OP0201 effectively absorb to the air-liquid interface of the mucosa and reduce the interfacial surface tension of the ET, which reduces 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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completion of product development or clinical trials, including the four
ongoing OP0201 clinical trials; expectations regarding the success of
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