Atai Life Sciences reports results from Phase 1 trial of KUR-101

atai Life Sciences announced additional clinical data from the Kures Therapeutics Phase 1 trial of KUR-101 in healthy volunteers. This two-part trial was designed to assess the safety, tolerability, pharmacokinetics, and analgesic activity of KUR-101. Part 1 consisted of a double-blind, randomized, 5-cohort single-ascending dose study to evaluate the safety and analgesic activity of a single oral dose of KUR-101 in a total of 42 healthy volunteers. Analgesic activity was assessed by the cold pressor test and impact on respiration was evaluated by measuring respiration rate at multiple time points. As previously reported, KUR-101 was well tolerated and produced dose-dependent analgesic activity without clinically significant effects on respiration at any dose-level tested, including at the 90mg dose level selected for the Part 2 comparator study. Part 2 consisted of a randomized, double-blind, crossover study to evaluate the safety and analgesic activity of KUR-101 compared to both oxycodone and placebo. 18 healthy volunteers were enrolled and randomized into one of three sequences. Each subject received single oral doses of KUR-101, oxycodone, and placebo separated by a 7-day washout. Analgesic activity was measured by both CPT and thermal testing. Respiratory rate was assessed at multiple time points. Results from part 2 showed that a single dose of 90mg of KUR-101 was generally well tolerated and was observed to produce analgesic effects on CPT comparable to those seen in Part 1 of this trial. The analgesic effects of KUR-101 were less than those seen with oxycodone on both CPT and thermal testing. Further, both KUR-101 and oxycodone demonstrated effects on respiration comparable to placebo, thus precluding definitive conclusions of KUR-101’s respiratory impact.