Novus Therapeutics said that a Phase 2a clinical trial of its OP0201 intranasal surfactant MDI for the treatment of acute otitis media in infants and children failed to meet its primary endpoints of “resolution of bulging tympanic membrane at visit 2 and resolution of middle ear effusion at visit 3.” The study did show greater resolution of middle ear effusion for children receiving OP0201 compared to placebo, 56% for OP0201 versus 38% for placebo.
Novus President and Head of Global R&D Catherine Turkel said, “Although we did not achieve statistical significance for the primary efficacy endpoints, we are encouraged with the statistical trend that favored the OP0201 treatment group with regard to resolution of middle ear effusion. Middle ear effusion is a key diagnostic criterion for otitis media disorders, including acute otitis media. When middle ear effusion persists after an episode of acute otitis media, it may make children susceptible to more serious otitis media disorders, such as recurrent acute otitis media and/or chronic otitis media with effusion. These topline results, including evidence supporting the safety and tolerability in infants and children, support continued development of our surfactant-based nasal aerosol. We are grateful to the young patients, their parents/caregivers, and the investigators who supported this clinical trial.”
The company also said that it had hired advisors to help determine its next steps, which could include “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.”
CEO Gregory J. Flesher commented, “We recognize that continued development of our surfactant-based nasal aerosol will require significant time and capital. 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.”
Read the Novus Therapeutics press release.
