Novus Therapeutics Inc. (NASDAQ:NVUS) shares lost almost 50% of its value after the company delivered disappointing results of its Phase 2a exploratory clinical study of OP0210 in the treatment of acute otitis media.
OP0201 study data fails to meet statistical significance
The clinical trial was a double-blind, randomized, single-center, parallel-group, placebo-controlled study. It assessed the tolerability, safety, and efficacy of 20mg intranasal OP0201 daily. As an alternative therapy to oral antibiotics in treating acute otitis media in children and infants between 6 and 24 months.
The study participants received treatment twice per day for ten days, and then there was a follow up for one month. Similarly, there were post-randomization visits between 4 and 6 days, 12 and 14 days, as well as 28 and 30 days. The primary endpoint for efficacy was the bulging tympanic membrane resolution after day 4 to 6, as well as middle ear effusion resolution after the third visit.
The company indicated that the study failed to attain statistical significance in meeting the primary endpoint targets. Nevertheless, Novus was encouraged with the statistical trend favoring OP0201 in treating the participants more so about middle ear effusion.
Topline data supports the development of surfactant nasal aerosol
Catherine Turkel, the company’s Global R&D Head, and President indicated that despite the study not meeting considerable statistical significance, its statistical trend favoring the use of the drug in middle ear effusion resolution was encouraging. She added that middle ear effusion was a major diagnostic measure for otitis media disorders such as acute otitis media. Further, she explained that when there is persistent middle ear effusion following an acute otitis media episode, it makes results in the child being susceptible to severe otitis media disorders like chronic/recurrent otitis media with effusion.
The topline results from the study plus evidence supporting tolerability and safety in children and infants support the continued development of the company’s surfactant nasal aerosol. The president acknowledged the role that their young patients played, including caregivers/parents and investigators who were key in the study.