TGA Receives Ananda’s Clinical Trial Notification

Ananda Pharma PLC

28 April 2025

 

28 April 2025

ANANDA PHARMA PLC

("Ananda" or the "Company")

Therapeutics Goods Administration receives Ananda's Clinical Trial Notification

Ananda Pharma plc (AQSE: ANA, OTCQB: ANANF), a UK-based biopharmaceutical company developing regulatory approved, cannabinoid medicines to treat complex, chronic conditions, is pleased to announce that its Phase I clinical trial, "A Phase 1, Open-Label, Multiple Dose Study to Assess the Pharmacokinetics, Safety, Tolerability, and Food Effect of MRX1 in Healthy Adults", has been acknowledged by the Therapeutic Goods Administration ("TGA") in Australia under the Clinical Trial Notification ("CTN") scheme.

MRX1 is Ananda's lead investigational cannabidiol (CBD) drug formulation, 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:

·      The CTN scheme allows clinical trials to be conducted in Australia with the approval of a Human Research Ethics Committee (HREC) and enables their expedited commencement

·      The Phase I clinical trial aims to characterise the pharmacokinetic profile, safety and tolerability of MRX1 at multiple doses, providing data to support regulatory filings and optimise dosing levels in future trials

·      To view the supporting video by Jeremy Sturgess-Smith, Finance Director of Ananda Pharma, and ask questions, please visit  our Hub: https://investors.anandapharma.co.uk/link/vPnA1r

Ananda's CEO, Melissa Sturgess, commented: "We are pleased to receive acknowledgement of our clinical trial under the TGA's CTN scheme, which is an important milestone in advancing our MRX1 development program. The data from this trial will be key for regulatory filings in the US, UK and Europe."

"Australia is an attractive location for clinical research due to its streamlined regulatory process and high-quality clinical trial infrastructure. This strategy is now paying off and we look forward to initiating the study and advancing our efforts to bring MRX1 to patients in need."

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.

For more information, please visit our website:

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

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ANANDA PHARMA PLC	[phone]
	[e-mail]
Chief Executive Officer
Melissa Sturgess
Finance Director
Jeremy Sturgess-Smith
SP ANGEL CORPORATE FINANCE LLP
Corporate Finance	[phone]
Richard Morrison
Josh Ray
Corporate Broking	[phone]
Abigail Wayne	[e-mail]
Rob Rees	[e-mail]
VIRIDIAN CAPITAL ADVISORS (US) Scott Greiper	[phone] [e-mail]
YELLOW JERSEY PR Sarah MacLeod Charles Goodwin Zara McKinlay	[phone] [e-mail]

 

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