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atai Life Sciences Announces Results from the Kures Therapeutics Phase 1 Trial of KUR-101
- This two-part phase 1 trial in healthy volunteers was designed to assess the safety, pharmacokinetics, and analgesic activity of KUR-101 - KUR-101 was well
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[{"type":"text","content":"- This two-part phase 1 trial in healthy volunteers was designed to assess the safety, pharmacokinetics, and analgesic activity of KUR-101 - KUR-101 was well tolerated and demonstrated analgesic activity in two experimental pain models - An assessment of the respiratory impact of KUR-101 was inconclusive as the positive control, oxycodone, failed to separate from placebo - KUR-101, a deuterated derivative of mitragynine, is a low-potency, partial mu-opioid receptor (MOR) agonist designed to produce therapeutic effects without clinically significant respiratory depression NEW YORK and BERLIN, Dec. 23, 2022 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (Nasdaq: ATAI) (“atai” or “the Company”), a clinical stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today 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 (10mg, 20mg, 40mg, 60mg, 90mg) in a total of 42 healthy volunteers. Analgesic activity was assessed by the cold pressor test (CPT) 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 (6 subjects each). Each subject received single oral doses of KUR-101 (90mg), oxycodone (20mg), 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 t...