I like to share a question i asked argenica about...

I like to share a question i asked argenica about efficacy........they answered.................

dudemug65

You

07:17PM 20/03/2024

Whats the level of efficacy needed for arg 007 to be of interest to bigger buy in pharma companies ? and are the company confident it can acheive prior to listing on the asx ?



Hi Mark, Thanks for your question and we appreciate your support as a shareholder. It is worth noting that safety is the biggest hurdle to overcome when running clinical trials in neurological conditions in large unmet needs such as stroke. The regulatory bodies, including the FDA in the US, require that the drug does no harm to stroke patients for it to be approved. And then, given there are currently no neuroprotective drugs on the market, the efficacy hurdle is reasonably small, it just needs to be better than no treatment in terms of functional outcome.From our preclinical data in models that reflect the current standard of care, we showed a 66% reduction in brain tissue death after 24 hours and a 70% reduction 28 days after stroke, which resulted in an improvement to functional outcomes.The main aim of our current Phase 2 study is to prove that the drug is safe and does no harm to stroke patients, this will provide pharmaceutical companies comfort that the main hurdle for drug approval has been met. We will also be collecting a number of measures of efficacy which will hopefully point to the drug having an impact on reduction in brain cell death and functional outcomes for stroke patients, however it must be noted that the current Phase 2 study does not have enough people in it to provide a statistically significant functional outcome measure, but it will be able to tell us if there is a trend in efficacy. This, combined with the safety data, and all our previous preclinical data, should get the interest of phama companies who will then hopefully partner with Argenica to undertake a large Phase 3 study which will have enough patients to determine the functional outcome efficacy of ARG-007.

Thanks Argencia