Pharmaceutically optimized drug candidate for the treatment of chronic phase of primary Glomerulonephritis

Avexxin is a pharmaceutical company that develops and commercializes innovative small molecules for the treatment of patients with chronic inflammatory diseases. Avexxin's knowledge of the biology of the inflammatory process has resulted in a new therapeutic approach for the treatment of psoriasis, glomerulonephritis and several other inflammatory conditions, as well as cancer. A large number of patients worldwide suffer from chronic invalidating diseases where inflammation is common symptom. Glomerulonephritis, or chronic renal infection, is a progressive kidney disease that over time leads to renal failure and results in the collection of excess liquid and toxins in the body. Based on Avexxin's new approach to chronic inflammation, the company aims to develop a pharmaceutically optimized drug candidate for the treatment of chronic phase of glomerulonephritis. The drug candidate may potentially change the course of disease and delay its harmful effects on the kidneys. During the four years the project period includes, a number of early optimization activities, followed by traditional pre-clinical development steps to identify and control the therapeutic properties of the optimized drug candidate has been completed. By the end of the four-year period, ie end 2018, Avexxin's goal has been to get the optimized drug candidate ready for approval for testing in humans. AVX002 in a subcutan formulation has in collaboration with Harvard Medical School in the United States, successfully tested in a total of three different animal models for the treatment of chronic renal inflammation. The therapy shows very good qualities in all models. Joint mechanism is anti-inflammatory and parallel to this anti-fibrotic by inhibiting TGFb-induced signaling. Avexxin has also received target validation for its upcoming drug for the treatment of chronic renal infection, ie, based on the three animal models that have been run, now specifically shown that recovery of diseased animals is because our inhibitors have inhibited the enzyme cPLA2a, and that no improvement of health in the animals is due to random effects. The project has had a very significant impact on Avexxin's economic development and value. Avexxin has decided to go public on the stock exchange to acquire sufficient resources to conduct clinical testing of the drug for the treatment of chronic renal inflammation, as well as other indications. Successful private placement with SEK 20 million from Norwegian and Swedish investors is in place. Stock listing is scheduled for mid 2019. Due to this project, the company now has several molecules to play for the development of therapies for chronic diseases in several diseases, including fibrosis. Having more molecules to play in developing optimal therapies for various diseases is priceless.

Avexxin har med dette prosjektet økt sin produktportefølje, har utvidet og styrket sitt internasjonale nettverk, og dessuten styrket samarbeidet med norsk industribedrift. De langsiktige virkninger av prosjektet blir uttesting av en potensielt ny medisin for behandling av kronisk nyrebetennelse. Dette er en sykdom som det pr. idag ikke finnes tilfredsstillende behandling for. Pasienter med denne lidelsen står i stor fare for å miste sin nyrefunksjon og må transplantere friskt nyre.

Avexxin AS aims to develop and commercialize a pharmaceutically optimized drug candidate for the treatment of the chronic phase of Glomerulonephritis (GN). GN is a progressive kidney disease that involves the glomeruli, the individual filtering units of the kidney that produce urine. When the glomeruli become inflamed, the kidneys cannot filter urine properly, resulting in a buildup of excess fluid and toxins in the body. GN can lead to chronic renal (kidney) failure. Primary GN affects the kidneys dire ctly, while in secondary GN the kidneys are damaged as a result of other primary diseases, such as diabetes and hypertension. GN is the third most common cause of ESRD (End Stage Renal Disease) in USA and Europe. NTNU and Avexxin's discovery of a unique and novel therapeutic intervention point in the pro-inflammatory signaling cascade (the intracellular enzyme grVIa cPLA2) offers a completely new disease modifying approach to therapeutic treatment of potentially a range of severe chronic inflammatory di sorders. A successful outcome of the project will result in an optimized drug candidate that will have the potential to introduce a new treatment paradigm for GN (disease modifying) and thereby alter the therapeutic landscape worldwide within this disea se.