A1M Pharma's candidate drug ROSgard™ shows protective effect against acute kidney injury in American preclinical studyA1M Pharma announces that the company's candidate drug ROSgard™ shows a strong protective effect against acute kidney injury (AKI) in a preclinical study conducted in the USA in collaboration with Indiana University. The positive results correlate well with recently reported results from a similar study conducted in Europe. The company has thus created an increasingly solid basis for the continued development of ROSgard™ in the field of acute kidney injuries. A phase I study is scheduled to start later in 2018, with the primary aim of evaluating the candidate drug's safety profile. The preclinical AKI study in the USA was conducted with another animal species and with a partially different method compared to the study in Europe. The results show that the placebo group displayed a substantial increase of AKI biomarkers while the groups that were administered with ROSgard™ displayed a significant reduction in all biomarkers.
"With these preclinical results we are now well positioned to study different pathophysiological conditions that are known to lead to AKI together with world leading companies based in the USA as well as Europe, each specialized in their unique subclinical field of AKI. The follow-up studies that we are now planning in Europe and the USA will provide a valuable basis for the design of future clinical studies with ROSgard™ within AKI," says A1M Pharma's Head of Development Eddie Thordarson.
"The clear and positive results from the AKI studies in the USA and Europe provide further evidence that ROSgard™ has the potential to help patients at risk of developing kidney injuries. The fact that the results are based on two different models in which both animal species and approach differ is a sign of strength. Today, there are no specific therapies to treat AKI and the interest in new treatments is immense, both from healthcare professionals and global pharmaceutical companies," says A1M Pharma's CEO Tomas Eriksson.
The American AKI study was led by professor Bruce Molitoris, a past President of American Society of Nephrology.
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. 2018-08-10 For more information, please contact
Tomas Eriksson, CEO
Telephone: +46 46-286 50 30
Email: [email protected]
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A1M Pharma Pressrelease 2018-08-10 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 which 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 opening the possibility of increasing treatment levels and so fight 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 is 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.
This information is information 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 the 10 August 2018 at 15.00.
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