- Argenica Therapeutics (AGN) completes the final phase one pharmacokinetic (PK) study of ARG-007
- The study was undertaken in rodents and aimed to determine how ARG-007 is absorbed, distributed, metabolised and excreted by the body
- The study showed an effective range of roughly one to three milligrams per kilogram in rodents with no adverse effects observed
- Argenica will now undertake a phase one dose-escalating trial in volunteers before a phase two trial is carried out in stroke patients
- Shares in Argenica are down 2.04 per cent and are trading at 48 cents at 11:49 am AEST
Argenica Therapeutics (AGN) has completed the final phase one pharmacokinetic (PK) study of ARG-007.
The study was undertaken in rodents and aimed to determine how ARG-007 is absorbed, distributed, metabolised and excreted by the body.
Findings from the study have been instrumental in confirming the appropriate dosing guidelines for the upcoming phase one clinical trial.
The study showed favourable PK profiles in the dose range between 0.05 to five milligrams per kilogram (mg/kg), including an effective range of roughly one to three mg/kg in rodents.
Further, no adverse effects were observed in the rodents, indicating ARG-007 to be safe and well-tolerated.
The completion of the PK study marks the final step needed to finalise Argenica’s ethics submission with the only outstanding work the completion of the analysis of the pathology samples from the GLP toxicology studies.
The analysis was delayed due to the extensive lockdown in Shanghai and is now expected to be completed in the upcoming weeks.
Upon completion of the analysis, Argenica will submit the required documents to Bellberry’s Human Research Ethics Committee (HREC) for review and approval prior to the phase one human clinical trial of ARG-007.
“The completion of this full pharmacokinetics study is the final study required to finalise our ethics submission, allowing us to move closer to initiating our Phase 1 clinical trial,” CEO Dr Liz Dallimore said.
“Achieving favourable PK profiles in this animal study complements the positive data we have in our safety and toxicology studies, allowing us to now focus on finalising the ethics submission required for approval to commence our Phase 1 clinical trial.”
The phase one trial will be undertaken at the Linear Clinical Research facility in Perth and will be run as a dose-escalating trial across four volunteer groups.
The first group will receive the lowest dose of ARG-007, or a placebo, and if no adverse reactions are encountered the second group will begin dosing.
Given the layout of the trial, preliminary results are expected to be announced throughout the trial which is expected to take roughly six months.
The aim of the trial is to improve Argenica’s understanding of how ARG-007 affects the body as well as evaluate the safety and determine the ideal dosage.
The data will also play an important role in planning the phase two study where ARG-007 will be administered to stroke patients.
Shares in Argenica were down 2.04 per cent and were trading at 48 cents at 11:49 am AEST.