Ananda Pharma Limited, a UK pharmaceutical company developing regulatory approved cannabidiol medicines to treat complex, chronic conditions, announced on Wednesday the completion of its Phase 1 pharmacokinetic study of MRX1, confirming favourable safety and tolerability and dose selection for future clinical studies.
The Phase 1 study was designed to assess the pharmacokinetics, safety and tolerability of multiple doses of MRX1 in healthy adult volunteers. Two dose levels were tested: 2.5 and 7.5 mg/kg of body weight.
The company says that the study's positive outcomes support continued clinical investigation into Phase 2 and provide further confidence in the its clinical and regulatory strategy.
According to Ananda, MRX1 demonstrated a favourable tolerability profile under the conditions evaluated in healthy volunteers following twice daily dosing for 6 days at dosing levels of 2.5 mg/kg and 7.5 mg/kg per dose under fasted conditions and following a single dose at 2.5 mg/kg under fed conditions. All reported Treatment Emergent Adverse Events (TEAEs) were mild in severity. There were no moderate or severe TEAEs or TEAEs that led to study drug discontinuation, study withdrawal or death.
There were no meaningful changes over time observed for any clinical laboratory parameter, and no abnormal clinically significant laboratory parameters were reported at any time during the study, including liver function parameters.
Safety and tolerability were consistent with the established clinical profile of approved CBD therapies.
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