Ananda Pharma PLC - Achievement of Manufacturing Milestone for MRX1

 20 February 2025

ANANDA PHARMA PLC 

("Ananda" or the "Company") 

Achievement of Manufacturing Milestone for MRX1

Ananda Pharma plc (AQSE: ANA) (formerly Ananda Developments plc) is a UK-based biopharmaceutical company developing regulatory approved, cannabinoid medicines to treat complex, chronic conditions.

Highlights:

·    Completion of manufacture of final technical batch of MRX1 CBD drug candidate to support data for the Investigational Medicinal Product Dossier (IMPD)

·    IMPD is crucial for MHRA clinical trial approval

·    The next MRX1 manufacturing batch will be delivered to clinical trial sites and dosed into trial participants

·    Visit our interactive Hub to hear Jeremy Sturgess-Smith, Finance Director, discussing the importance of this development and to submit questions to the management team via the Hub by clicking this link.

This manufacturing step is key in the preparation of MRX1 for use in clinical trials. Data generated from technical batches confirms that MRX1 meets the detailed specifications, batch-to-batch consistency and shelf-life standards detailed in the IMPD, which is required for regulatory approval of clinical trials by the Medicines and Healthcare Products Regulatory Agency (MHRA). This data will also be required in regulatory documents for other jurisdictions, such as the Federal Drug Administration in the USA.

The next step is to produce the first Good Manufacturing Practice (GMP) clinical batch of MRX1 for dosing participants in the chemotherapy induced clinical pain trial (CIPN) being led by Professor Marie Fallon at Edinburgh University, the endometriosis clinical trial being led by Dr Lucy Whitaker, also at Edinburgh University and the Phase 1 pharmacokinetic study the Company will be running in Australia.

Ananda's CEO, Melissa Sturgess commented:

"The detailed and intricate work to ensure our MRX1 CBD drug candidate meets the requirements for MHRA clinical trial approval is progressing well.  These workstreams provide the foundations of Ananda's house and must be built properly." 

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 (trials funded by NHS England and NIHR), endometriosis (funded by NHS Scotland) and chemotherapy pain (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 at:  

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

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-Ends-  

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.  

https://investors.anandapharma.co.uk/link/6eWYaP