Novus Therapeutics announced topline results from study C-006, a phase 2a clinical trial of OP0201 in acute otitis media. Statistical significance was not achieved for the primary efficacy endpoints, although a statistical trend favored the OP0201 treatment group in regards to resolution of middle ear effusion.
Study C-006 was a single center, double-blind, randomized, placebo-controlled, parallel group clinical trial to assess the safety, tolerability, and efficacy of 20 mg per day intranasal OP0201 as an adjunct therapy to oral antibiotic in the treatment of acute otitis media in infants and children 6 to 24 months of age. Subjects were treated twice-daily for 10 days and followed up to one month. Post-randomization visits occurred between days 4-6 (visit 2), days 12-14 (visit 3), and days 28-30 (visit 4). The primary efficacy endpoints included resolution of bulging tympanic membrane at visit 2 and resolution of middle ear effusion at visit 3.
In the trial, 51% of the patients in the OPO201 cohort met the day 4 objective compared to 47.3% in the placebo arm. For the day 12 endpoint, 55.2% of the drug cohort met the endpoint compared to 27.9% for control. The other primary endpoint was safety, and 87.3% of patients receiving OPO201 experienced a treatment-emergent adverse event compared to 75.0% for placebo.
In conjunction with these results, Novus announced that the Board of Directors has initiated a process to explore strategic options intended to maximize shareholder value. The company has engaged financial advisors to assist in the review and evaluation of strategic options. Such options may result in a financing to continue development of the surfactant-based nasal aerosol, a company sale, merger, asset sale, in-license, out-license, or other business transaction.
“We recognize that continued development of our surfactant-based nasal aerosol will require significant time and capital,” said Gregory J. Flesher, CEO of Novus Therapeutics, Inc. “We must fund the company for several years in order to complete additional formulation and device development, initiate the next otitis media clinical trial, and ultimately deliver clinical data. Given our current valuation relative to our capital needs, and given the operational challenges with the ongoing COVID-19 pandemic, we believe that exploration of all options is the appropriate course of action,” concluded Mr. Flesher.
OP0201is 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 a 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 Eustachian tube (ET), which is a small tube that connects from the chamber of the middle ear 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.
About Acute Otitis Media (AOM)
AOM is usually a short-term inflammation of the middle ear, characterized by the sudden onset of one or more signs or symptoms of acute middle ear inflammation (e.g., ear pain, fever or irritability) in the presence of MEE. AOM is often preceded by upper respiratory symptoms including cough and rhinorrhea. Micro-organisms (viral or bacterial) in the nasopharynx may reflux into the middle ear, where they adhere and colonize resulting in an ear infection. AOM is extremely common in young children, many of whom will have multiple AOM episodes (RAOM) over the course of months or even years.