The company has reported positive results from a preclinical study in the field of acute kidney injury (AKI).

The primary endpoints show that the active substance in the company’s candidate drug, ROSgard, reduces the damaging effects on kidneys following exposure to severe oxidative stress.

The study is a stage in A1M Pharma’s previously announced work on evaluating potential indications in the field of acute kidney injuries, for the purpose of optimising the long-term development strategy for ROSgard. Data from the study shows that the active substance in ROSgard has a significant effect on clinically relevant acute kidney injury biomarkers.

In collaboration with Phenos

The study, conducted in collaboration with the German contract research organization Phenos, was based on a standardised and validated animal model designed to reflect the clinical situation for a number of medical conditions associated with acute kidney injury. As expected, the placebo group displayed a substantial increase of acute kidney injury biomarkers in both blood and urine and tissue damage to the kidneys. In those groups dosed with the active substance in ROSgard, a protection of kidney tissue was shown together with a significant reduction in all biomarkers.

Commercial potential

“Based on these clear, positive results from the study, A1M Pharma will continue to evaluate ROSgard in additional preclinical research models for acute kidney injury — an area with major commercial potential that is in great need of improved medicinal therapy. This type of study is important for us in such things as designing inclusion criteria in future clinical studies,” says Eddie Thordarson, Head of Development at A1M Pharma.

A1M Pharma’s preclinical program in acute kidney injury is independent of the company’s application to the Swedish Medical Products Agency regarding the conduct of a clinical phase I study and does not impact the schedule for clinical trials with ROSgard.