So, what is all the excitement in the new data? It can't be discovered in the spike and reversal of the share price but has to be found in the scientific literature, the pre-clinical animal studies and the results from the Phase 1 clinical results in healthy volunteers. The CEO said in an interval with Proactive Investors that for the first time AdAlta has been able to link efficacy seen in animal studies to the results seen in the Phase 1 clinical trial.
There have been a number of animal studies but I'm intending to focus upon the administration of AD-114 in a mouse model of renal fibrosis. Note: the results were also validated in a second model using AD-214; reference is made to the article, A single-domain i-body, AD-114, attenuates renal fibrosis through blockade of CXCR4 published February 2022.
It begs the question, what was the efficacy seen in the animal studies? In particular, patients with chronic kidney disease (CKD) would be interested as to whether AD-214 could potentially rescue kidney function. One might be appreciative that AD-214 could work as a preventative therapy but the real and meaningful outcome would be the reduction of renal fibrosis and corresponding improvement in kidney function following the onset of the disease.
It so happens that it does both i.e. improves kidney function in the preventative mouse model and improves kidney function in the therapeutic mouse model. The results from the therapeutic model are key because its the scenario that is most relevant to the clinical setting. In other words, the most relevant for patients with CKD who have very few to none treatment options and face the prospect - in the event of kidney failure - of a kidney transplant or dialysis.
Interesting facts from the US and The National Kidney Foundation:
- 37m American adults have chronic kidney disease (mostly undiagnosed)
- 660,000 live with kidney failure
- 100,000 are waiting for a kidney transplant
Just to recap, the data from the animal studies suggest that AD-214 has potential for therapeutic use in reversing kidney disease. The new data links the dosage rates and receptor occupancy results from the clinical trial back to the animal studies that in turn provides greater confidence that AD-214 is an extremely promising therapeutic in an enormous global market with unmet need.
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