Ananda Developments plc signs a contract with Southern Star Research Pty Ltd

Ananda Developments plc (AQSE: ANA), a life sciences company focused on the research and clinical development of therapies for a range of complex inflammatory pain conditions, is pleased to announce that it has signed a contract with Southern Star Research Pty Ltd (‘SSR’), a leading Australian Contract Research Organisation, to carry out a Phase 1 clinical trial investigating the pharmacokinetic (“PK”) profile, tolerability and safety of the Company’s lead investigative asset, MRX1.

Ananda has elected to conduct this Phase 1 study to provide in-human data on its MRX1 drug candidate, specifically related to PK, tolerability, and safety. This data will provide useful background information when discussing MRX1 and the wider Ananda drug development pipeline with potential investors, in partnering discussions with pharmaceutical companies, and with clinician investigators for clinical trials in other indications. Crucially, the study will form a foundational piece of the data package for regulatory filings.

Further to this, the findings from the PK study can be used as a key data source for submission of an Investigational New Drug (‘IND’) application to the Federal Drug Administration (‘FDA’) in the United States – a key first step to having a drug approved for use in the USA.

The next steps for the study are to complete the trial protocol and finalise agreements with a Phase 1 unit that will run the trial site, before progressing to Human Research Ethics Committee (“HREC”), and a Clinical Trial Notification will be filed with the Therapeutic Goods Administration (Australian regulatory body) as well as securing a Good Manufacturing Practice certification of the MRX1 drug batch.

About the MRX1 Phase 1 PK study

The study will dose 20 healthy volunteers with MRX1. It will measure PK levels following an acute (single) dose, as well as chronic dosing (where the PK levels will be measured over a period of six days) to investigate the accumulation of MRX1 in the body over the course of the study. The volunteers will be hospitalised for the duration of the study and include equal numbers of males and females.

Conducting the study in Australia

The study will be conducted in Australia because it has a vibrant Phase 1 offering and financial advantages. The Australia Tax Office offers a 43.5% cash rebate on all Research & Development work undertaken in Australia. The study will be conducted via Ananda’s wholly owned Australian subsidiary, Tiamat Australia Pty Ltd.

About MRX1

MRX1 is an oil based, orally administered drug candidate which is to be used in two Phase 2 clinical trials, the first evaluating MRX1’s efficacy in treating Chemotherapy Induced Peripheral Neuropathy (“CIPN”) and the second study is evaluating efficacy and retention in endometriosis patients.

Melissa Sturgess, CEO of the Company, commented:

This study represents a significant milestone in MRX1's journey to market, providing us with key data for MRX1’s licensed drug development. Working with an excellent company such as Southern Star Research is a reflection of the high quality of work produced by the Ananda team. Southern Star Research’s deep expertise in clinical research, particularly in the field of cannabinoids, will complement our own capabilities and accelerate the development of MRX1. We all look forward to updating shareholders as we progress through the deliverables on this project.

Dr. David Lloyd, Managing Director of Southern Star Research Pty Ltd, commented: "We are thrilled to be collaborating with Ananda Developments on their Phase I Pharmacokinetics study of their lead asset, MRX1, to be assessed in Healthy Volunteers. Southern Star Research have extensive experience in managing and executing Phase I clinical trials and also clinical studies involving Cannabinoids such as Cannabidiol (CBD). The therapeutic potential of CBD is still yet to be fully discovered, and we hope that our collaboration with Ananda will further support the advancement of MRX1 and the wider acceptance of CBD as a therapeutic solution within mainstream health. We have enjoyed our working collaboration with the Ananda team to date and look forward to bringing their Phase I PK study to life here in Australia."