Ananda Pharma PLC - MRX1 Granted Ethics Approval for Phase 1 Study

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU, WHICH IS PART OF UNITED KINGDOM DOMESTIC LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

 2 April 2025

ANANDA PHARMA PLC 

("Ananda" or the "Company") 

Ananda's Lead Drug Candidate MRX1 Granted Ethics Approval for Phase 1 Study

Ananda Pharma plc (AQSE: ANA), a UK-based biopharmaceutical company developing regulatory approved, cannabinoid medicines to treat complex, chronic conditions, is pleased to announce that it has received approval from the Alfred Hospital Human Research Ethics Committee (HREC) in Australia for its Phase 1 pharmacokinetic study of MRX1, the Company's cannabidiol (CBD) drug candidate.

MRX1 is Ananda's lead investigational cannabidiol (CBD) drug candidate, in development for complex chronic inflammatory pain conditions. It is derived from high-purity, pharmaceutical-grade CBD, manufactured to stringent quality control standards to ensure consistency and stability.

Highlights:

·    HREC Approval confirms the Phase 1 trial protocol meets the necessary ethical standards required to commence recruitment

·    First-patient-first-dose is expected in Q3 2025, with initial results anticipated in Q1 2026

·    The study's objective is to characterise the pharmacokinetic profile of MRX1 at multiple doses as well as assessing the safety and tolerability of MRX1 in healthy volunteers

·    The study will deliver valuable data to support regulatory filings in key markets including the United States, United Kingdom and Europe as well as assist in the optimisation of dosing for the Company's future clinical trials

·    While this trial is not necessary for the start of the Phase 2 endometriosis and chemotherapy induced peripheral neuropathy trial with University of Edinburgh, findings from this study will inform future regulatory filings and support the design and implementation of future clinical trials to assess the potential therapeutic effects of MRX1 in specific patient populations. The Phase 1 study also opens opportunities for development activities in new markets, including as part of a planned Investigational New Drug Application to the Food and Drug Administration (FDA) in the United States

·    To view a video by Jeremy Sturgess-Smith, Finance Director and Jack Morgan, Chief Commercial Officer, and the chance to have your questions answered by them and the rest of the management team, please head to: https://investors.anandapharma.co.uk/link/XyM9py

Ananda's CEO, Melissa Sturgess commented: "I am incredibly proud of this achievement by our team.  Every step in in the drug development process is important and receiving the green light to proceed with our Phase 1 trial in Australia is a significant milestone in the development of MRX1 towards a regulatory filing."

For more information, please visit: https://investors.anandapharma.co.uk/

Study Design and Methodology

The Phase 1 study is being sponsored by the Company's wholly owned Australian subsidiary, Tiamat Australia Pty Ltd.

The study has been designed to assess the pharmacokinetics, safety and tolerability of two dose levels of MRX1 in 20 healthy adult volunteers. Due to known sex differences in CBD metabolism, the study will comprise 10 biological males and 10 biological females.

The study will include standard safety parameters and plasma pharmacokinetic parameters of CBD and its metabolites. Characterising the effect of a high fat, high calorie meal has also been included as a secondary objective, due to the known positive effects of food on the pharmacokinetics of CBD.

About Ananda Pharma

Ananda Pharma (AQSE: ANA) is a UK-based biopharmaceutical company developing regulatory approved, cannabinoid medicines to treat complex, chronic conditions, including epilepsy (two Phase 3a trials funded by NHS England and NIHR), endometriosis (Phase 2 trial funded by NHS Scotland) and chemotherapy pain (Phase 2 trial funded by NIHR).  The Company is led by successful entrepreneurs and is working with a team of world-class scientists, including globally respected Key Opinion Leaders at the University of Edinburgh, Great Ormond Street Hospital for Children and University College London.

To stay abreast of the latest developments at Ananda, we encourage you to follow our social media channels which are:  

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For the purposes of UK MAR, the Directors of the Company accept responsibility for the contents of this announcement.