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news.Paion, a biopharmaceutical company, has reported the first positive human data from the Phase I proof of concept study of its intravenous sedative or anaesthetic CNS 7056.
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The Phase I proof of concept study compared intravenous CNS 7056 to placebo and a standard dose of midazolam, the current gold standard for procedural sedation. The anticipated favorable profile was observed and no safety issues were raised. Volunteers treated with increasing doses of CNS 7056 were successfully sedated at the higher dose cohorts as expected and recovered to full consciousness rapidly, the company said.
The stopping criterion for the study was pre-determined as more than 50% of the volunteers reaching loss of consciousness for more than five minutes. In the ninth out of 10 planned doses this criterion was met. No serious adverse events occurred, even at doses that induced unconsciousness.
According to the company, dose dependent sedation, with a rapid onset of effect, was observed after administration of CNS 7056 at doses of 0.05mg/kg and higher. Doses of CNS 7056 (0.075 – 0.20mg/kg) that induced peak sedation levels similar to or greater than those achieved with midazolam (0.075mg/kg) showed a markedly shorter duration of sedative effect with recovery from sedation within approximately 10 minutes compared to approximately 40 minutes for midazolam.
The peak sedative effect of CNS 7056 was reached within four minutes in these dose groups, with initial onset of sedation being observed after approximately one minute. For midazolam, the peak effect was reached after approximately 15 minutes. Duration and depth of sedation increased with higher doses of CNS 7056, while the recovery was still earlier as compared to midazolam.
Paion will now progress to the next stage of development and start seeking a partner for territories outside Japan in parallel to the commencement of Phase II. In Japan, CNS 7056 is partnered with Ono Pharmaceuticals. The company now plans one study with healthy volunteers in colonoscopies and one study with patients undergoing upper gastrointestinal endoscopies. Both studies are expected to start no later than third quarter of 2009.