SP Angel publishes research note on Ananda
SP Angel, a small London based investment bank, have recently publish a reseach note on Ananda.
Ananda supplying formulations for four mid/late-stage clinical trials
Ananda continues to make significant progress across its operations particularly in terms of its clinical trial activities. Ananda was recently selected to provide cannabinoid formulations for two UK phase 3 clinical trials evaluating CBD only and CBD plus THC as treatments for refractory (drug resistant) epilepsy. These trials will be run by University College London (UCL) and Great Ormond Street Hospital (GOSH) with Ananda paid to supply the formulations. The Group is also continuing preparations with researchers at the University of Edinburgh to evaluate MRX1 in two Phase 2 trials for two underserved disease indications. One trial is investigating the effect of MRX1 on CIPN, funded by National Institute for Health and Care Research (NIHR), and the other is investigating its effect on endometriosis, funded by the Chief Science Office (CSO) Scotland. The lead investigators for these trials are all internationally recognised researchers in their respective fields, highlighting the clinical interest in Ananda’s products.
Selection for these clinical trials is a significant validation of the Group’s approach
The selection of Ananda to supply formulations for these trials is a significant validation of the Group’s science-led approach to therapeutic development. The largest barriers in the adoption of cannabisbased medicines into clinical practice is the lack of consistent pharmaceutical grade products and a lack of evidence from placebo controlled clinical trials. Trial results should provide clinical and patient confidence regarding the safety of MRX formulations and support future regulatory and reimbursement discussions.
Upcoming PK study enables additional data generation on the activity of MRX1
Ananda is also planning a Phase 1 trial in Australia which aims to dose 20 healthy volunteers with MRX1 and evaluate the pharmacokinetic (PK) profile, tolerability and safety of MRX1. The study provides an opportunity to understand how MRX1 is absorbed and eliminated from the body. This data can be used to help confirm the safety profile of the treatment and determine the appropriate dosage. Data from this trial can also support IP filings and regulatory discussions with the US FDA.
Clinical testing is expected to begin in 2025
The initiation of testing of any of these trials would mark the shift of Ananda into a clinical stage company, a significant value inflection point. With four investigator led studies set to begin across a range of diseases we believe there is an opportunity to invest prior to first dosing of patients and the generation of clinical data which, if positive, should generate significant industry & clinical interest.