Argenica (ASX:AGN) mark the manufacturing milestone for clinical trialsDecember 14, 2023
Argenica Therapeutics has finished manufacturing the ARG-007 drug substance required for Phase 2 clinical trials with a finalised sterile drug product set for completion by year’s end, ensuring the company can begin landmark first patient dosing early in the new year.
Final approvals for hospital clinal trials also remain on course, one is ready to begin patient dosing, with several others now in the final stages of approval.
And the Independent Data Safety Monitoring Board is now established and ready for Phase 2 to begin, set to provide key data on the safety and preliminary efficacy of the treatment for acute ischaemic stroke patients.
It paves the way for a pivotal Phase 3 and potential partnerships, and Argenica Managing Director Dr Liz Dallimore said that proving the scale-up manufacturing of clinical grade ARG-007 was a significant milestone, and the company was delighted manufacturing timelines remained on track.
“Further, we are pleased with the progress of research governance at each hospital, there is a lot of work going on behind the scenes in the Company to prepare for our upcoming Phase 2 trial. We look forward to keeping shareholders updated as further milestones are achieved,” Dr Dallimore said.
The trial is slated to generate preliminary data on ARG-007’s ability to reduce brain tissue death after stroke and mechanical removal of brain clots, and proving a neuroprotective ability would mark a significant derisking and place the company at the fore of neuroprotective clinical validation.
The treatment has been granted Orphan Drug Designation by the Food and Drug Administration for treatment of Hypoxic Ischaemic Encephalopathy, a designation which opens up not only tax credits for clinical trials and user fee exemptions, but potentially seven years of market exclusivity.
And there could be a lot more to ARG-007, which has shown ability to reduce the cellular uptake of alpha-synuclein, the ‘Parkinson’s Protein’, aggregates by 84 per cent, with the inhibitory effect increasing up to 90 per cent with further doses, and to significantly reduce braincell damage caused by traumatic brain injuries.
Argenica received a grant to fund the pre-clinical efficacy studies required to initiate clinical trials in newborns suffering from hypoxic-ischaemic encephalopathy, and with no therapeutic drug of its kind on the market, could lead to a medical breakthrough.
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