Announcement • Jul 17
Ananda Pharma Limited Doses First Patient In ACTiON Clinical Trial For MRX1 In Chemotherapy Induced Peripheral Neuropathy Ananda Pharma Limited has dosed the first patient in the ACTiON clinical trial investigating the efficacy of MRX1, Ananda's proprietary CBD-based drug candidate, in treatment of patients with Chemotherapy Induced Peripheral Neuropathy. The patient has been recruited, randomised and has taken their first dose of either MRX1 or placebo on the trial. The Phase 2 trial, led by Professor Marie Fallon of The University of Edinburgh and funded by the National Institute for Health and Care Research as a non-dilutive Efficacy and Mechanism Evaluation grant, is designed to assess the efficacy and safety of MRX1 in the treatment of Chemotherapy Induced Peripheral Neuropathy. It will also assess the impact of MRX1 on quality of life and healthcare utilisation. The trial is a double-blind, placebo-controlled, crossover study with a target enrolment of 92 participants. Chemotherapy Induced Peripheral Neuropathy is one of the most frequent chemotherapy side-effects but has no effective therapies and is considered a critical unmet medical need. In addition to continuing to affect patients following their cancer treatment it often means that chemotherapy dosing needs to be reduced or stopped during treatment and thus potentially increasing risk of death or duration of treatment. In the UK alone, there are more than 140,000 new cases of Chemotherapy Induced Peripheral Neuropathy per year and the prevalence runs into almost a million patients. In the US there are approximately 400,000 new patients each year at an annual healthcare cost of $2.5bn. Ananda Pharma is providing its MRX1 oral solution to two Phase 2 clinical trials: ENDOCAN (endometriosis pain, funded by NHS Scotland) and ACTiON (Chemotherapy Induced Peripheral Neuropathy, funded by an NIHR Efficacy and Mechanism Evaluation grant). Announcement • Jul 06
Ananda Pharma Delivers MRX1 Investigational Product To University Of Edinburgh Central Pharmacy For ACTiON Phase 2 Clinical Trial Ananda Pharma announced the MRX1 investigational product manufactured in 2025 has been delivered to the University of Edinburgh central pharmacy. This shipment supports the initiation of the ACTiON Phase 2 clinical trial, which is being run in partnership with the University of Edinburgh. Participant screening is now underway at the clinical trial site in preparation for first participant first dose. This milestone marks a significant step on the clinical development pathway as it brings Ananda closer to dosing its first ever Phase 2 clinical trial patient with MRX1, following the successful completion of its first in-human study earlier this year. The Company will provide further updates when first participant first dose has been confirmed. The Phase 2 trial, led by Professor Marie Fallon of The University of Edinburgh and funded by the National Institute for Health and Care Research (NIHR) as an Efficacy and Mechanism Evaluation (EME) grant, is designed to assess the efficacy and safety of MRX1 in the treatment of CIPN. It will also assess the impact of MRX1 on quality of life and health care utilisation. The trial is a double-blind, placebo controlled, crossover study with a target enrolment of 92 participants. CIPN is one of the most frequent chemotherapy side-effects but has no effective therapies and is considered a critical unmet medical need. In addition to continuing to affect patients following their cancer treatment it often means that chemotherapy dosing needs to be reduced or stopped during treatment and thus potentially increasing risk of death or duration of treatment. In the UK alone, there are more than 140,000 new cases of CIPN/year and the prevalence runs into almost a million patients. In the US there are approximately 400,000 new patients each year at an annual healthcare cost of $2.5bn. Ananda Pharma is 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. Announcement • Jun 19
Ananda Pharma Limited Completes Phase 1 MRX1 Pharmacokinetic Study and Confirms Favourable Safety and Tolerability Ananda Pharma Limited has completed its Phase 1 pharmacokinetic study, 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. 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. 
