A1M Pharma reports positive results from preclinical study in acute kidney injuries

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. Top-line data from the study shows that the active substance in ROSgard has a significant effect on clinically relevant acute kidney injury biomarkers.

The study, conducted in collaboration with the German contract research organization Phenos GmbH, 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.

"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.

About acute kidney injuries
The kidneys are not only the body's treatment plant, they are also the control centre for the vital function of blood pressure regulation and thus the balance of salt and water in the body. This means that by and large, impaired kidney function affects all bodily functions. Acute kidney injury can occur in the event of incidents such as poisoning and infections, and in connection with severe bleeding, oxygen deprivation or certain types of cancer treatments and importantly in the context of major cardiac surgery. Kidney injuries can also be caused by diabetes, high blood pressure and glomerulonephritis, which is an inflammatory condition in which the kidney's filtration units (called 'glomeruli') are damaged. In all these cases, oxidative stress is an important contributing factor to the injuries. If the injuries are extensive, chronic kidney failure can result, which requires dialysis or a kidney transplant.

23 July 2018

For additional information, please contact:
Tomas Eriksson, CEO
Telephone: +46 46-286 50 30
E-mail: [email protected]

This information is of the type that A1M Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was provided, through the above contact, for publication on 23 July 2018 at 08:20 CET.

The following documents can be retrieved from beQuoted
A1M Pharma Pressrelease 2018-07-23 English.pdf

About A1M Pharma
Several preclinical studies indicate that A1M Pharma's candidate drug, ROSgard™, based on the endogenous protein Alpha- 1-Microglobulin, restores impairments to kidney function by repairing damaged tissue and protecting against oxidative stress. Kidney injury is a condition which often occurs in connection with preeclampsia and often limits the possibilities of using radiation therapies as a treatment for cancer. The company's two indications are kidney protection in connection with Peptide Receptor Radionuclide Therapy (PRRT) - a targeted radiation therapy for cancer - with the aim of allowing increased treatment levels and thus fighting metastatic cancer more effectively as well as treatment of preeclampsia. Every year, over 12 million people are affected by acute kidney injuries that can lead to permanent kidney damage. Preeclampsia affects around 10 million pregnant women worldwide and is responsible for 76,000 maternal and 500,000 infant deaths each year. A1M Pharma has been listed on Nasdaq First North Stockholm since 20 June 2017. A1M Pharma's Certified Adviser at Nasdaq First North is Erik Penser Bank AB, +46 8-463 80 00.

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