Ananda Pharma plc (AQSE: ANA) (OTC: ANANF), a UK-based biopharmaceutical company focused on cannabidiol-based medicines, on Monday announced the completion of dosing in its Phase 1 pharmacokinetic (PK) study for MRX1 CBD. This achievement marks the Last Participant, Last Dose (LPLD) milestone in the trial conducted in Melbourne, Australia.
All 19 healthy adult volunteers (9 male, 10 female) across two dosing cohorts have received their final MRX1 dose.
Next steps will include database locking and commencement of data analysis. Safety and tolerability readouts are expected in Q4 2025, with a draft clinical trial report targeted for Q1 2026.
Data from this trial will be utilised for FDA filings and to inform the design of future trials.
This milestone represents a significant step in Ananda's mission to develop regulatory-approved cannabidiol medicines to address complex conditions such as endometriosis and chemotherapy-induced peripheral neuropathy.
Ananda Pharma is advancing cannabinoid therapeutics with clinical programmes supported by NHS Scotland and NIHR, led by a team of world-class scientists including experts from the University of Edinburgh.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval