Ananda Developments Plc (AQSE:ANA) chairman Charles Morgan described as "profound" the preclinical data generated by its lead asset in an area of cardiology with a high unmet medical need.
CBD-derived MRX1, currently also undergoing Phase II trials for chemotherapy-induced peripheral neuropathy and endometriosis, was assessed for its potential in treating cardiac fibrosis and heart failure with preserved ejection fraction (HFpEF).
Research conducted by Dr Nadine Godsman and Dr Sarah Walsh at Robert Gordon University (RGU), under the guidance of Professor Cherry Wainwright, a member of Ananda’s scientific advisory board, showed promising results. The study involved male mice divided into two groups: one fed a high-fat diet with L-NAME, a substance used to induce heart stress mimicking HFpEF, and a control group on a normal diet. MRX1 or a modified version was administered orally during the last two weeks of the seven-week study.
Cardioprotective effects
The results indicated that MRX1 had significant cardioprotective effects. Heart and lung weights in treated mice returned to near-normal levels. Additionally, MRX1 significantly reduced brain natriuretic peptide (BNP) levels, a marker of cardiac stress, suggesting a reduction in cardiac dysfunction. The drug was easy to absorb when taken by mouth and helped lower blood pressure, reduce heart swelling, and prevent tissue thickening in the heart.
"We are delighted to share this profound pre-clinical data with the market, which establishes that MRX1, our patent-pending drug candidate, has a clinical impact. HFpEF is an area of high unmet medical need,” said chairman Morgan. “We are excited by the opportunity this presents to add another addressable condition to our portfolio alongside our existing two phase II trials investigating chemotherapy-induced peripheral neuropathy and endometriosis."
The data from the study has been included in Ananda’s international patent application for MRX1 and were presented at the 9th Federation of European Pharmacological Societies (EPHAR) conference in Athens. Cardiac fibrosis, which involves the thickening and stiffening of heart tissue, can severely impair heart function. HFpEF manifests as heart failure symptoms despite normal pumping ability and is becoming more common with ageing populations and increasing health issues.
Context
In an interview with Proactive, the company’s co-founder and finance director, Jeremy Sturgess-Smith, contextualised the findings. “Outside of Epidiolex [GW Pharma’s treatment for severe epilepsy], this is one of the first pieces of proper data that shows that the CBD molecule and in particular, Ananda's patent-pending formulation, MRX1, has a genuine medical impact in a condition where there is a high unmet need,” he explained.
“So we see it [the data] as opening up an exciting avenue to another clinical trial for Ananda's growing portfolio and to explore what is really a new condition for MRX1.”
Sturgess-Smith noted it was too early to determine how a third clinical study would be funded or the level of interest in this third potential indication for MRX1. Given the lack of alternative treatments and the high mortality rate associated with HFpEF, it is expected that there will be significant interest.
Ananda is not a one-trick pony, with two Phase II clinical evaluations underway. Sturgess-Smith describes Aquis-listed Ananda as “punching well above its weight” in this regard. “We are also countering the narrative that small-cap drug discovery and development is dead,” he adds, referencing the trend of life sciences companies opting to go private amid a funding drought.
Ananda has shown proficiency in securing non-dilutive grant funding to support its clinical efforts—a financing strategy many companies overlook.
Next steps
Looking ahead, Sturgess-Smith stated: “On HFpEF, following the announcement of this data, we will sit down with the research team at Robert Gordon University and assess what the recommended next steps are: Either a larger second mice study or, our preference, to start putting together an in-human study.
"For both our phase II studies, we're expecting first patient, first dose later this year and we’ll see some news around that coming, hopefully, at some point later in the year."