Novus Therapeutics said that two Phase 1 trials of its OP0201 intranasal MDI, which is in development for otitis media, both met their primary endpoints. In one of the studies, healthy adults received either a single 20 mg dose of OP0201 or placebo and were then exposed to pressure changes in a pressure chamber. In the other, adults with acute otitis media received 20 mg of OP0201 or placebo.
The OP0201 formulation combines a surfactant (dipalmitoylphosphatidylcholine [DPPC]) cholesteryl palmitate [CP], which is a spreading agent. According to Novus, “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 [eustachian tube], which reduces passive pressure required for the ET to open. In other words, OP0201 is intended to promote ‘de-sticking’ of the ET so that ventilation of the middle ear may occur.”
Novus Therapeutics President Catherine Turkel commented, “We are delighted that results from single-dose Phase 1 studies met the primary objectives and demonstrated a favorable safety and tolerability profile. The safety profile of OP0201 was similar to placebo, and also similar when administered to healthy adults or adults with acute otitis media. Study participants did not report any adverse effect as it relates to taste or smell after exposure to OP0201. In study C-001, we did not observe any adverse effect on eustachian tube function. In study C-004, the majority of the participants in both treatment groups reported relief of ear pain, although no treatment difference was observed between the treatment groups.”
Turkel continued, “We have also recently completed our multiple-dose phase 1 safety trial, and in the coming months we will report data from the 14-day, dose-escalation safety and tolerability study in healthy adults. Further, this past February we initiated our phase 2a pediatric otitis media development program which is ongoing, and by year end we will have our first look at safety, tolerability and efficacy with 10 days of OP0201 treatment compared to placebo in infants and children with acute otitis media.”
Read the Novus Therapeutics press release.
