All study objectives met
MRX1 well tolerated, Phase 2 dosing on track to start H2 2026
Data reinforces case for therapeutic doses of MRX1 Oral Solution
Further confidence on regulatory and clinical strategy
LONDON, June 17, 2026 /PRNewswire/ -- Ananda Pharma Limited is a UK pharmaceutical company developing regulatory approved cannabidiol medicines to treat complex, chronic conditions.
The directors announce that the Company's Phase 1 pharmacokinetic study has now been completed, yielding highly encouraging data that confirms favourable safety and tolerability and dose selection for future clinical studies. The positive outcomes of the study support continued clinical investigation into Phase 2 and provide further confidence in the Company's clinical and regulatory strategy.
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.
This safety and tolerability profile was consistent with the established clinical profile of approved CBD therapies, a finding that supports the scientific rationale underpinning our FDA 505(b)(2) development pathway.
Ananda's CEO, Melissa Sturgess, commented: 'This is an important achievement for Ananda and puts us in a strong position as we move into dosing patients in the forthcoming ENDOCAN and ACTION Phase 2 clinical trials.'
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 effect of food was also assessed for lower dose level (2.5 mg/kg). A total of 20 participants received at least one dose of MRX1, with 10 participants 2.5 mg/kg twice daily and 10 receiving 7.5 mg/kg twice daily. After a 14-day wash-out period, 9 of the 10 participants who had previously been dosed with MRX1 2.5 mg/kg in Period 1 received a single dose of MRX1 2.5 mg/kg after consuming a high-fat, high-calorie meal.
About Ananda Pharma
Ananda Pharma is a UK pharmaceutical company providing its MRX1 oral solution to two Phase 2 clinical trials: ENDOCAN (endometriosis pain, funded by NHS Scotland) and ACTION (CIPN, funded by an NIHR EME grant). The Company works with world-class scientists, including Key Opinion Leaders at the University of Edinburgh.
Contact Details:
Jeremy Sturgess-Smith
Finance Director
ir@anandapharma.co.uk
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