Summary of Preliminary KET-IR Phase 1 Study Results:
- Single Ascending Dose (SAD) Study: In the SAD study, KET-IR was administered as an oral capsule at doses between 40 and 240 mg in 6 double-blind placebo-controlled cohorts enrolling a total of 18 healthy volunteers. Based on pre-specified dose escalation stopping criteria, a maximum tolerated dose (MTD) was not established.
- Safety, Tolerability and Pharmacokinetics:
KET-IR was generally well tolerated following dose escalation from 40mg to the final planned dose of 240 mg. Blood levels of ketamine and ketamine metabolites were similar to levels associated with therapeutic ketamine administration at several dose levels (Perez-Ruixo et al. 2020 and Singh et al. 2016).
All adverse events reported were mild or moderate in intensity and resolved within hours without study interruption or medical intervention. No serious adverse events were reported. Measures of clinical activity known to be associated with ketamine treatment were observed at several dose levels, including dissociation and mild sedation.
- Several dose levels showed a pharmacokinetic profile suitable for continuous dosing regimens, with dose linearity across all levels tested. Furthermore, rapid drug exposure and clearance properties were consistent with those reported for immediate-release ketamine formulations (Perez-Ruixo et al. 2020 and Singh et al. 2016).
Neurocentrx is an Edinburgh-based biopharmaceutical company focused on the development of oral ketamine for the treatment of major mental health conditions, including mood disorders. The Company aims to gain regulatory approval for the first prescription form of oral ketamine to treat depression and has developed a novel and proprietary abuse-deterrent ketamine oral formulation. Neurocentrx is a growth-phase company headquartered in the UK and is seeking corporate partners and investors to support future clinical development. For more information, please visit the website: www.neurocentrx.com.
About KET-IR and AD-KET-IR
KET-IR and AD-KET-IR are Neurocentrx’s proprietary oral ketamine immediate-release formulations for the treatment of major mental health conditions. AD-KET-IR is an oral ketamine capsule formulation being developed under FDA guidance to limit the potential for misuse and diversion of controlled substances. Since launching operations in 2013, Neurocentrx continues to expand its patent and intellectual property estate portfolio covering novel compositions and methods for delivering oral ketamine therapy for patients and healthcare providers across diverse care and community settings.
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About King’s College London and the Institute of Psychiatry, Psychology & Neuroscience
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