Novus Therapeutics has provided an update on ongoing Phase 1 clinical trials of its OP0201 nasal MDI for the treatment of otitis media and has announced plans for a Phase 2a study in infants and children.
The new randomized, double-blind, placebo-controlled Phase 2a trial (C-006), which replaces a planned Phase 1 study in children with otitis media with effusion, is expected to enroll 50 patients aged 6 months to 24 months with acute otitis media. The study will evaluate OP0201 given in addition to oral antibiotics. Data from the trial are expected to be available in the second half of the year.
In June 2018, Novus said that it had received guidance from the FDA confirming that a Phase 2 study in infants could be initiated after completion of a safety study in adults. The company announced in November 2018 that it had initiated a Phase 1 study in healthy adults.
Novus Therapeutics CEO Gregory J. Flesher commented, “We have made good progress with the OP0201 development program over the past few months and we are looking forward to reporting data from four clinical trials this year. We initiated screening for study C-001, a single-dose phase 1 safety and pharmacodynamic effects study. We completed the first dose cohort of study C-002, the ongoing 14-day phase 1 adult safety and tolerability study, and have initiated screening for the second higher dose cohort. We expect data from these two clinical trials to be available in the second calendar quarter of 2019.”
Flesher added that enrollment in an additional Phase 1 study in adults with acute otitis media (C-004) has been completed and data are expected by the end of the first quarter.
Read the Novus Therapeutics press release.
