Ananda Developments Advances Cannabinoid Medicines in Phase III Epilepsy Trials
Key Insights
Ananda Developments (search)' MRX2 (search) and MRX2T (search) formulations selected for two Phase III trials targeting drug-resistant epilepsies, funded by NIHR and NHS England.
The trials will assess the safety and efficacy of CBD and CBD+THC in reducing seizure frequency and improving quality of life in 500 patients.
Ananda's MRX1 formulation demonstrates cardioprotective effects in preclinical studies for Heart Fibrosis with Preserved Ejection Fraction (search) (HFpEF).
Ananda Developments (search) PLC is making significant strides in the development of cannabinoid-based medicines, with its MRX2 (search) and MRX2T (search) formulations chosen for two Phase III clinical trials targeting refractory epilepsies. These trials, funded by the National Institute for Health and Care Research (NIHR) and NHS England, will investigate the efficacy of cannabidiol (CBD) and CBD combined with tetrahydrocannabinol (THC) in reducing seizure frequency and severity in patients with drug-resistant epilepsies.
Phase III Trials for Refractory Epilepsies
The two Phase III randomized controlled trials will be the first to investigate the combined use of CBD and THC for epilepsy (search) in a broad range of difficult-to-treat epilepsies. Up to 500 patients across the UK will be recruited at multiple NHS sites over 18 months. Patients will be randomly assigned to receive either MRX2 (search) (CBD), MRX2T (search) (CBD + THC), or a matched placebo, all supplied by Ananda Developments (search) plc.
The trials will assess the impact of these treatments on various factors, including learning, sleep, behavior, quality of life, stress, and anxiety. The formulations being used are Ananda's patent-pending MRX2 (search) (CBD) Oral Solution, MRX2T (search) (CBD + THC) Oral Solution, and a matched placebo. The scale and design of the Phase III trials aim to provide a greater understanding of both the benefits and potential risks of MRX2 and MRX2T as new treatments.
Preclinical Success in Heart Fibrosis
In addition to the epilepsy (search) trials, Ananda Developments (search) has reported positive pre-clinical study results for its patent-pending MRX1 CBD formulation in the potential treatment of Heart Fibrosis with Preserved Ejection Fraction (search) (HFpEF). The study demonstrated significant cardioprotective effects in mice, suggesting MRX1's potential as a therapeutic option for HFpEF and other cardiac conditions.
Phase I Pharmacokinetic Study of MRX1
Ananda's Australian subsidiary has contracted Southern Star Research Pty Ltd to conduct a Phase I clinical trial investigating the pharmacokinetic profile, tolerability, and safety of MRX1 in healthy volunteers. This study will generate data to inform future clinical trials and support regulatory applications, including those with the MHRA in the United Kingdom and the FDA in the United States. The company anticipates benefiting from Australia's R&D Tax Incentive, which could cover up to 43.5% of eligible research and development costs.
Scientific Advisory Board Expansion
To further bolster its scientific expertise, Ananda Developments (search) has appointed Professor Marie Fallon to its Scientific Advisory Board. Professor Fallon, a leading expert in palliative medicine and cancer pain, is also the lead investigator for Ananda's Phase II study investigating the pain-relieving effects of MRX1 in patients with Chemotherapy Induced Peripheral Neuropathy (search) (CIPN).
These advancements underscore Ananda Developments (search)' commitment to developing innovative cannabinoid medicines for conditions with significant unmet medical needs.