ANA Ananda Developments Plc

26 June 2024

ANANDA DEVELOPMENTS PLC

("Ananda" or the "Company")

Promising Results from Cardiac Fibrosis Studies with MRX1

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

Ananda, 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 indicate 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)

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.

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​Elevated BNP levels are indicative of cardiac stress and dysfunction, this graph shows a statistically relevant reduction in 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.

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-Ends-

For further information, please contact:

https://investors.anandadevelopments.com/link/vPn3Yy

The Directors of the Company accept responsibility for the contents of this announcement.

Market Abuse Regulation (MAR) Disclosure

The information contained within this announcement is deemed by the Company to constitute inside information. Upon the publication of this announcement via a Regulatory Information Service, this inside information is now considered to be in the public domain.

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Definitions:

·    Heart Failure with Preserved Ejection Fraction (HFpEF): HFpEF is a type of heart failure where the heart muscle contracts normally, but the ventricles do not relax as they should during diastole. This condition leads to symptoms of heart failure despite a normal ejection fraction, which measures the percentage of blood leaving the heart each time it contracts.

·    Fibrosis: Fibrosis refers to the thickening and scarring of connective tissue, usually as a result of injury or long-term inflammation. In the heart, fibrosis can lead to stiffness and impaired function, contributing to conditions such as heart failure.

·    Anti-Hypertensive: Anti-hypertensive refers to any medication or therapy that reduces high blood pressure (hypertension). These agents help in managing blood pressure levels, thereby reducing the risk of heart disease, stroke, and other related health issues.

·    Anti-Hypertrophic: Anti-hypertrophic describes a substance or treatment that prevents or reduces hypertrophy, which is the enlargement of an organ or tissue due to an increase in the size of its cells. In the context of the heart, it refers to preventing the thickening of the heart muscle.

·    Pressure Volume Loop (PVL): A pressure volume loop is a graphical representation of the relationship between the pressure in the ventricles of the heart and their volume during one cardiac cycle. It provides valuable insights into cardiac function, including contractility, compliance, and overall heart performance.

·    High-Fat Diet with L-NAME: This diet is used in experimental models to induce conditions such as obesity and hypertension. L-NAME (Nω-Nitro-L-arginine methyl ester) is a compound that leads to increased blood pressure and the mimicking of cardiovascular disease states.

·    Molecular Markers: Molecular markers are specific sequences of DNA, RNA, or proteins that indicate a particular biological state or condition. In the context of cardiac studies, these markers help identify the presence and extent of heart failure, fibrosis, and inflammation.

·    Cardiac Remodelling: Cardiac remodelling refers to the changes in the size, shape, structure, and function of the heart after injury or stress. This process can be beneficial or detrimental, depending on the context and extent of the changes.

·    Diastolic Function: Diastolic function refers to the ability of the heart ventricles to relax and fill with blood during the diastolic phase of the cardiac cycle. Impaired diastolic function can lead to heart failure with preserved ejection fraction (HFpEF).

·    Systolic Function: Systolic function refers to the heart's ability to contract and pump blood during the systolic phase of the cardiac cycle. It is often measured by the ejection fraction, indicating the percentage of blood ejected from the ventricles with each heartbeat.

·    Hypertension: Hypertension is a chronic medical condition characterized by consistently elevated blood pressure. It increases the risk of heart disease, stroke, and other health problems if left unmanaged.

·    Bioavailability: Bioavailability refers to the proportion of a drug or compound that enters the systemic circulation when introduced into the body. It indicates how effectively a substance is absorbed and utilized by the body.