The safety report released today has given Argenica the confidence to progress to the Phase-2 clinical trial in stroke patients later this year. 

Neuroprotective therapeutics Argenica Therapeutics (ASX:AGN) jumped 5% this morning after releasing the safety data on its Phase-1 clinical trial of ARG-007 in healthy human volunteers.

The interim safety report concluded there were no clinically significant adverse events seen in participants dosed with ARG-007 at any of the dosage levels tested.

The only adverse events observed during the trial were mild to moderate, and these were observed in both the ARG-007 treatment groups and placebo group, with a greater percentage seen in the placebo group.

“We’re delighted to receive this data package from Linear confirming the safety and tolerability of ARG-007,” said Argenica CEO, Dr Liz Dallimore.

“Receiving the unblinded data and comparing the treatment groups with the placebo groups in our Phase-1 clinical trial shows that we are not seeing any clinically significant adverse events related to administration of ARG-007.“

Argenica will now work with its clinical partner Linear Clinical Research to finalise the clinical trial report in collaboration with an experienced medical writer.

This report will form part of the ethics submission for the Phase-2 clinical trial in stroke patients.

Phase-1 study details

Linear also provided an  evaluation of laboratory parameters, vital signs, physical findings, and other observations related to safety, notably monitoring heart conditions through electrocardiograms (ECG).

The report concluded that no clinically significant findings were observed in any of these measures.

Furthermore,  TEAEs (treatment emergent adverse events) showed that 54.2% of ARG-007 treated participants experienced at least one mild or moderate TEAE.

However a larger percentage or 62.5% of the placebo group experienced at least one mild or moderate TEAE.

The report noted that an adverse TEAE event observed following the commencement of ARG-007 or placebo (saline) may or may not be related to the administration of the drug.

In total, there were 31 reported TEAEs in all participants, however only 10 of these were considered “related” to the administration of ARG-007.

In addition, these related TEAEs were not dependent on the dose of ARG-007 administered,  since the highest dose of ARG-007  did not result in any adverse events.

The data  also  provided findings on the presence of nine different cytokines which are typical immune dysfunction biomarkers, to investigate whether ARG-007 caused an immune reaction.

There were no notable trends in changes from baseline levels over time within any of the treatment groups or as the dose increased, meaning ARG-007 does not induce an immune reaction when administered at any of the four doses tested.

These safety results will be included in Argenica’s ethics submission for Phase-2 clinical trial in stroke patients later this year.

“We can now work with Linear to finalise the trial report in preparation for our ethics submission to commence our Phase-2 trial in ischaemic stroke,” said  Dallimore.

“Pleasingly, the data generated from the safety report, will also be able to be used for a number of other Phase-2 trials in additional indications,” she added.

Diversified pipeline

Argenica is developing novel therapeutics to reduce brain tissue death after stroke and other types of brain injury and neurodegenerative diseases.

Its lead peptide candidate, ARG-007, has been successfully demonstrated to improve outcomes in pre-clinical stroke models such as traumatic brain injury (TBI) and hypoxic ischaemic encephalopathy (HIE).

Argenica is also exploring other indications for ARG-007,  including Alzheimer’s Disease.

In February, the company received a non-dilutive cash funding of $350k from philanthropic donors via the Perron Institute to progress preclinical studies into the efficacy of ARG-007 in Alzheimer’s Disease.

Dosing in this study is due to commence this month,  with final results to be received later this year.

 

 

 

This article was developed in collaboration with Argenica Therapeutics, a Stockhead advertiser at the time of publishing.

 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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