atai Life Sciences Announces the Results of the Kures Therapeutics Phase I 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 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 trial, which consisted of two parts, was designed to evaluate KUR-101’s safety, tolerability and pharmacokinetics as well as its analgesic properties.
Part 1 was a double blinded, randomized, 5-cohort, single-ascending dose trial to assess the safety and analgesic activities of KUR101 (10mg-20mg; 40mg; 60mg; 90mg) in 42 healthy volunteers. CPT was used to evaluate analgesic activities. Impact on respiration was measured by measuring the respiration rate at multiple times. KUR-101, as previously reported, was well tolerated. It produced dose-dependent analgesic activities without any clinically significant effects on respiratory function at any dose-level, even the 90mg level used in the Part 2 comparison study.
Part 2 was a double-blind, randomized crossover study that evaluated KUR-101’s analgesic and safety performance against oxycodone or 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. CPT and thermo testing were used to determine analgesic activities. Multiple time points were used to assess the respiratory rate.
Part 2 results showed that 90mg of KUR101 was well tolerated. It was also observed to have analgesic effects on CPT similar to those in Part 1. KUR-101’s analgesic effect was less than that of oxycodone in 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.
“We are pleased that KUR-101 was both well tolerated and demonstrated clinical activity in healthy volunteers. As the data comparing the respiratory effects of KUR-101 to both oxycodone and placebo are inconclusive at this stage, additional research will be needed to further characterize the therapeutic potential of KUR-101,” said Florian Brand, CEO and Co-Founder of atai.
KUR-101
Current OUD treatments like methadone, buprenorphine, and naltrexone are not effective for many patients. They have inconvenient treatment protocols, side effects, and restrictions due to abuse liability. KUR-101, however, is an unusual opioid receptor modulator that has a unique and safer pharmacology. Its deuteration increases its pharmacokinetic safety profile and reduces dosing requirements.
About atai Life Science
Atai Life Sciences, a biopharmaceutical company in clinical stage, aims to revolutionize the treatment of mental disorders. atai was established in 2018 to address the unmet demand and lack of innovation in mental health treatment. They are committed to developing and acquiring innovative therapeutics that treat depression, anxiety, and addiction.
Atai hopes to responsible accelerate the development of new medications across its companies, using best practices and pooled resources, to achieve clinically meaningful behavioral change in mental patients.
atai’s vision is to heal mental health disorders so that everyone, everywhere can live a more fulfilled life. Please visit www.atai.org to find out more. www.atai.life.
About Kures Therapeutics
Kures Therapeutics, an atai life sciences company, is a Columbia University spinout and is currently developing KUR-101 in the treatment of acute pain and OUD. KUR101 is a deuterated derivative (or derivative) of mitragynine. It is a low-potency muopioid receptor (MOR), agonist. It is a semi-synthetically manufactured drug substance, which has been designed to increase the safety and efficacy of mitragynine. Preclinical results have shown that KUR-101 can analgesia at therapeutic doses without causing significant respiratory depression in animals.
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