Ananda Developments - Ananda Developments Epilepsy Trials

21 October 2024

ANANDA DEVELOPMENTS PLC 

("Ananda" or the "Company") 

Ananda cannabinoid medicines to be used in NHS epilepsy trials

Landmark studies represent the largest investigational trials to be conducted to date for cannabinoids as a treatment for refractory epilepsy

Ananda Developments plc (AQSE: ANA) is pleased to announce that two of its patent pending cannabinoid medicines, MRX2 and MRX2T, will be used in two National Institute for Health and Care Research (NIHR) and NHS co-funded Phase IIIa epilepsy clinical trials involving up to 500 patients in total. The trials will be run by investigators at University College London and Great Ormond Street Hospital.

Highlights:

·      MRX formulations will be used as the investigational medicinal products (IMPs) in two NIHR/NHS funded Phase IIIa randomised controlled trials (RCTs) investigating the treatment of complex epilepsies

·      Trial 1: MRX2 (CBD), MRX2T (CBD + THC) versus placebo in patients with refractory (drug-resistant) early onset epilepsies.

·      Trial 2:  MRX2 (CBD), MRX2T (CBD + THC) versus placebo in patients of normal cognitive ability with refractory genetic generalised epilepsies.

·      The study has been designed to support a marketing authorisation application for MRX2 & MRX2T and therefore, should the trials deliver successful results, MRX intends to progress further regulatory and commercial development  activities of these medicines

·      Existing evidence suggests cannabis-based medicinal products are promising treatments for difficult to treat epilepsies, with one CBD-only medicine already licenced to treat three rare conditions associated with drug-resistant epilepsy

·      In combination, the trials will involve up to 500 patients from across the UK and together, will be the largest investigational trials conducted to date for cannabinoids as a treatment for refractory epilepsy

·      Ananda will be paid to supply MRX2, MRX2T and the matching placebo

·      A pre-recorded video relating to this news, is available for viewing via the Company's investor hub and Ananda's Finance Director Jeremy Sturgess-Smith will be recording a Q&A specific to these trials in a week. Investors are invited to submit questions in advance to be answered during the recording at: https://investors.anandadevelopments.com/link/lyaapy. 

The objective of the trials test the safety and efficacy of Ananda's specific cannabidiol (CBD) and CBD plus tetrahydrocannabinol (THC) formulations for two treatment-resistant epilepsy groups in children and adults. If the results are favourable, they will pave the way for a submission of these medicines to the MHRA and other regulatory bodies for regulatory approval.

The trials are being funded by a partnership between NHS England and National Institute for Health and Care Research (NIHR) and will be co-led by Professor Finbar O'Callaghan and Professor Helen Cross of University College London (UCL) and Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH).

Researchers will study whether these medicines are safe and effective in reducing the number and severity of seizures experienced by individuals, as well as whether they affect learning, sleep, behaviour, quality of life, stress, and anxiety.

These will be the world's first double blind randomised controlled trials to investigate the use of CBD and THC together for epilepsy, and the first to evaluate the medicines in children and adults who have a broad range of difficult-to-treat epilepsies. Previously, double blind randomised controlled trials investigated the use of CBD-only in three rare conditions associated with drug-resistant epilepsy (Dravet Syndrome, Lennox Gastaut Syndrome, and tuberous sclerosis complex).

500 patients will be recruited across the UK at multiple NHS sites. The patients will be randomly assigned either CBD, a combination of CBD and THC, or a matched placebo manufactured to the specifications of Ananda Developments plc's formulations, which patients will take for 24 weeks. The formulations being used for the trials are Ananda's patent pending MRX2 (CBD) Oral Solution, MRX2T (CBD + THC) Oral Solution, and a matched placebo. The scale and design of the Phase IIIa trials will provide a greater understanding of both the benefits and potential risks of MRX2 and MRX2T as new treatments.

NICE has estimated that the combined direct and indirect costs of epilepsy to the NHS are £2 billion per annum and most of this is spent on patients with refractory epilepsy.

Ananda's CEO, Melissa Sturgess commented: "The UK Government and the NHS have made it clear they need to see randomised controlled trials in a broad range of seizure types and epilepsies to enable wide prescribing of CBD- and THC-based medicines. We are proud that our MRX2 and MRX2T products meet the rigorous requirements for these trials and have received the support of internationally respected clinician investigators with expertise in refractory epilepsies.  Our clear objective is to deliver licensed CBD-based medicines which will be available on the NHS." 

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

About Ananda Developments  

Ananda is an AQSE-listed life sciences company focused on the research and clinical development of CBD-based therapies for a range of complex inflammatory pain conditions.

For more information, please visit: https://anandadevelopments.com

About UCL - London's Global University

UCL is a diverse global community of world-class academics, students, industry links, external partners, and alumni. Our powerful collective of individuals and institutions work together to explore new possibilities.

Since 1826, we have championed independent thought by attracting and nurturing the world's best minds. Our community of more than 50,000 students from 150 countries and over 16,000 staff pursues academic excellence, breaks boundaries and makes a positive impact on real world problems.

The Times and Sunday Times University of the Year 2024, we are consistently ranked among the top 10 universities in the world and are one of only a handful of institutions rated as having the strongest academic reputation and the broadest research impact.

We have a progressive and integrated approach to our teaching and research - championing innovation, creativity and cross-disciplinary working. We teach our students how to think, not what to think, and see them as partners, collaborators and contributors.  

For almost 200 years, we are proud to have opened higher education to students from a wide range of backgrounds and to change the way we create and share knowledge.

We were the first in England to welcome women to university education and that courageous attitude and disruptive spirit is still alive today. We are UCL.

www.ucl.ac.uk | Follow @uclnews on Twitter | Read news at www.ucl.ac.uk/news/ | Listen to UCL podcasts on SoundCloud | View images on Flickr | Find out what's on at UCL Minds

About GOSH - Great Ormond Street Hospital

GOSH is one of the top five children's hospitals in the world and of the technologically most advanced. Together with its primary research partner, the UCL Great Ormond Street Institute of Child Health (UCL GOS ICH), GOSH has developed several new clinical treatments and techniques that are used across the NHS and around the world.

About NIHR

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

·    Funding high quality, timely research that benefits the NHS, public health and social care;

·    Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;

·    Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;

·    Attracting, training and supporting the best researchers to tackle complex health and social care challenges;

·    Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;

·    Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.

About NHS England

The National Health Service (NHS) is the publicly funded healthcare system in England, and o, and one of the four National Health Service systems in the United Kingdom. It is the second largest single-payer healthcare system in the world after the Brazilian Sistema Único de Saúde. Primarily funded by the government from general taxation (plus a small amount from National Insurance contributions), and overseen by the Department of Health and Social Care, the NHS provides healthcare to all legal English residents and residents from other regions of the UK, with most services free at the point of use for most people. The NHS also conducts research through the National Institute for Health and Care Research (NIHR).

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.  

https://investors.anandadevelopments.com/link/5Pb9or