Ananda Pharma has reported positive results from its Phase 1 pharmacokinetic study of MRX1 oral solution, with all study objectives met and no safety concerns identified, supporting progression into Phase 2 development.

The UK-based pharmaceutical company, which is developing cannabidiol-based medicines for complex chronic conditions, said the study confirmed a favourable safety and tolerability profile in healthy volunteers and provided dose selection guidance for future trials.

MRX1 was evaluated following twice-daily dosing over six days at 2.5 mg/kg and 7.5 mg/kg under fasted conditions, as well as a single 2.5 mg/kg dose under fed conditions. According to the company, all reported treatment emergent adverse events (TEAEs) were mild in severity, with no moderate or severe events and no discontinuations, withdrawals or deaths.

The study also reported no clinically significant abnormalities in laboratory parameters, including liver function tests, and no meaningful changes over time across measured clinical laboratory values.

Ananda Pharma said the findings were consistent with the known clinical profile of approved cannabidiol therapies and supported its FDA 505(b)(2) regulatory pathway strategy.

The Phase 1 study was designed to assess pharmacokinetics, safety and tolerability of multiple MRX1 dose levels in healthy adult volunteers. A total of 20 participants received at least one dose of MRX1, with cohorts receiving either 2.5 mg/kg or 7.5 mg/kg twice daily dosing.

Following a wash-out period, nine participants from the lower dose cohort also received a single 2.5 mg/kg dose under fed conditions to assess the impact of food on pharmacokinetics.

Melissa Sturgess, chief executive of Ananda Pharma, said: “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 company said Phase 2 dosing is on track to begin in the second half of 2026.