Phase 1 PK Study to be conducted on MRX1

Ananda Developments PLC

09 October 2024

 

Certain 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.  

ANANDA DEVELOPMENTS PLC

("Ananda" or the "Company")

Phase 1 Pharmacokinetics Study to be conducted on MRX1

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.

Highlights:

·    Contract signed for Phase 1 PK study

·    The clinical trial will investigate the PK profile, tolerability and safety of MRX1 in healthy volunteers

·    The data generated will inform future clinical trials in patients and form an integral part of any future regulatory applications, including with the MHRA in the United Kingdom or FDA in the United States

·    Collected data will form part of Ananda's MRX1 patent estate and wider intellectual property portfolio

·    Significant financial advantages of running the study in Australia, including an R&D Tax Incentive of up to 43.5% of eligible research and development costs

Ananda recently posted a blog about the reasons for running a PK study which is available to read here,  the slides from a recent event regarding the reasons behind running a Phase 1 study in Australia are available here and a summary video of this announcement is also available on the Hub alongside the RNS.

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. You can read more about the CIPN clinical trial here and more about the endometriosis clinical trial here.

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."

Further updates will be provided to shareholders as the study progresses.

To stay up to date with the latest developments at Ananda, we encourage you to follow and join our social media channels which are:  

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·      LinkedIn: https://www.linkedin.com/company/anadevelopments/   

·      Twitter: https://twitter.com/AnandaPlc

·      Investor Meet Company: https://www.investormeetcompany.com/ananda-developments-plc/register-investor

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

For more information please contact:

InvestorHub Engage with us directly at Ananda Developments Investor Hub	Sign up at https://investors.anandadevelopments.com/s/a66906
ANANDA DEVELOPMENTS PLC Chief Executive Officer Melissa Sturgess Finance Director Jeremy Sturgess-Smith	[phone] [e-mail]
SP ANGEL CORPORATE FINANCE LLP Corporate Finance Richard Morrison Caroline Rowe	[phone]
Corporate Broking Abigail Wayne Rob Rees
Yellow Jersey PR Charles Goodwin Zara McKinlay	[phone]

About Ananda Developments

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

For further information on the Company visit https://anandadevelopments.com/ or sign up at https://investors.anandadevelopments.com/s/a66906.

https://investors.anandadevelopments.com/link/5Pm3Me

 

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