Novus Therapeutics provided updates on several ongoing and planned clinical trials with OP0201, the company’s lead product candidate being developed for otitis media. “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,” said Gregory Flesher, CEO of Novus Therapeutics. “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. In addition, we recently completed enrollment of study C-004, the single-dose phase 1 safety and exploration of efficacy study in adults with acute otitis media. Given the rapid enrollment of study C-004, we now expect to have data by the end of the first calendar quarter of 2019. Finally, we are pleased to announce the addition of study C-006, an exploratory phase 2a placebo-controlled study in infants and children with acute otitis media. This trial replaces the previously announced phase 1 open-label study in children with otitis media with effusion. This new phase 2a study is designed to explore multiple endpoints and help the company design larger phase 2 studies in patients. We expect enrollment of this trial to begin in the coming weeks, with data available in the second half of 2019,” concluded Flesher.
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