Novus Therapeutics has reported a favourable profile for its otitis media drug candidate OP0201 assessed in two single-dose Phase I clinical trials.
The C-001 and C-004 trials achieved the primary objective of safety and tolerability in healthy adults and adult patients with acute otitis media respectively.
Otitis media is commonly caused by Eustachian tube dysfunction (ETD). OP0201 is a nasal aerosol, drug-device combination product designed to restore the ET’s normal physiologic activity.
The randomised, double-blind, cross-over C-001 study assessed the safety, tolerability and Eustachian tube function over a 150-minute period after a single intranasal dose of OP0201 or placebo.
During the trial, the assessments were performed while patients were subjected to pressure changes in an atmospheric pressure chamber.
One or more adverse events were observed in 76.5% of subjects treated with OP0201, compared to 81.3% administered with placebo. No adverse effect was found on the Eustachian tube function.
Study C-004 involved patients with acute otitis media and moderate or worse ear pain. The drug candidate’s safety, tolerability and ability to offer ear pain relief were evaluated within a 60-minute period.
Overall, 16.7% of patients in the OP0201 group and 50% in the placebo arm had one or more adverse events. In addition, most of the subjects in the treatment groups experienced relief of ear pain.
Both trials did not find any serious adverse events.
Novus Therapeutics president Catherine Turkel said: “We are delighted that results from single-dose Phase I studies met the primary objectives and demonstrated a favourable 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.”
The company also concluded a multiple-dose Phase I safety trial and is currently performing a Phase IIa paediatric otitis media development programme.