Promising results from cardiac fibrosis studies with MRX1

MRX1 returns heart and lung weights to near-normal levels in pre-clinical study

Ananda Developments PLC, a clinical-stage life sciences company focused on the development of CBD based therapies for the treatment of a range of complex inflammatory pain conditions, is delighted to share promising results from recent preclinical studies investigating the efficacy of MRX1 (Patent Pending) in treating cardiac fibrosis and heart failure with preserved ejection fraction (HFpEF).

This research has been 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.

Highlights:

• Administration of MRX1  has shown significant cardioprotective effects in a mouse study, demonstrating its potential as a treatment for patients with heart failure with preserved ejection fraction (HFpEF).
• HFpEF is heavily linked to poor diet and lifestyle choices and accounts for 50% of heart failure cases.
• The research involved detailed assessments of cardiac function, plasma CBD levels, and molecular markers
• of heart failure, fibrosis, and inflammation.
• MRX1 exhibited multiple traits which an effectiveness in mitigating cardiac fibrosis and improving heart health.
• These datas have been included in Ananda’s International Patent Application  for MRX1.
• The data was presented yesterday afternoon for the first time at the 9^th Federation of European Pharmacological Societies (EPHAR) conference in Athens.
• The successful outcomes suggest MRX1 could be a valuable therapeutic option for HFpEF and other cardiac conditions and Ananda is currently investigating next steps on how to bring this promising treatment to clinical use.

Charles Morgan, Executive Chairman, said: “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 and 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 and other conditions that we are working up trials for.  Many thanks to the team at RGU and everyone at Ananda for all their efforts in bringing this project to completion. We look forward to updating all our stakeholders on our further progress in due course.”

A glossary of technical terms has been provided at the end of this announcement.

Cardiac Fibrosis and HFpEF

Cardiac fibrosis is a condition characterized by the thickening and stiffening of the heart tissue, often leading to impaired heart function. HFpEF, accounting for 50% of heart failure cases, presents as clinical heart failure symptoms with a normal ejection fraction. This condition's incidence is rising with the aging population and the increasing prevalence of comorbidities, making it a critical unmet need in cardiology.

Study Design

The study aimed to evaluate the cardioprotective effects of MRX1 in a preclinical HFpEF model and to explore whether terpenes could enhance these properties. The study involved male mice, aged 8-10 weeks, divided into two groups. One group received a high-fat diet with L-NAME, which was used to stress the mice heart and replicate the effects of HFpEF, while the control group was fed a matched/normal diet. MRX1 or an altered MRX1 was administered orally in the last two weeks of the seven-week study. Key assessments included:

• Cardiac function via pressure volume loop (PVL)
• Plasma CBD and metabolite analysis
• Molecular analysis of heart failure, fibrosis, and inflammation markers

Significant Findings from the Preclinical Study

Heart and Lung Weights

Administering a high fat diet to the mice increased both their lung and heart weights by a statistically significant amount.  Administering MRX1  to these mice resulted in the heart and lung weights returning to near the weights recorded before administering the high fat diet.  The alternative RGU MRX1 formulation did not perform as well.

 

 

 

 

 

 

 

 

 

 

_{These graphs illustrate that administration of MRX1 (yellow bar) returns the heart and lung weights to near normal levels (the green bar) Elevated BNP levels are indicative of cardiac stress and dysfunction, this graph shows a statistically relevant reduction BNP levels in mice that were fed MRX1} 

Markers of Cardiac Remodelling

Administering a high fat diet to the mice resulted in cardiac stress and dysfunction.  Administering MRX1  to these mice resulted in a significant reduction in cardiac stress and dysfunction measures.  The alternative RGU MRX1 formulation did not perform as well.

 

 

 

 

 

 

_{These graphs illustrate that administration of MRX1 (yellow bar) returns the heart and lung weights to near normal levels (the green bar) Elevated BNP levels are indicative of cardiac stress and dysfunction, this graph shows a statistically relevant reduction BNP levels in mice that were fed MRX1} 

The study demonstrated that MRX1 has good oral bioavailability and effectively exerts anti-hypertensive, anti-hypertrophic, and anti-fibrotic effects on the mice. The altered RGU MRX1 terpene blend did not significantly enhance these effects, indicating that the current formulation of MRX1 is optimal and is dosed at a clinically effective amount.

Conclusion

The findings suggest that MRX1 is a potent cardioprotective agent that could be instrumental in treating HFpEF and potentially other cardiac diseases. Ananda is excited about the potential for these advancements for future clinical use and is currently investigating next steps on how to undertake additional studies to conduct the further research and development necessary to bring this promising treatment to clinical use.

-Ends- 

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