Primary endpoint reached by SER150 Phase 2a study in Diabetic Nephropathy.
Oslo, 2 January 2017. Serodus (OSE: SER) today announced that no safety issues were identified in the Phase 2a study of SER150 in patients with Diabetic Nephropathy, and that a strong trend towards reduced protein excretion in the urine was observed.
”Serodus is excited about these SER150 results in patients with Diabetic Nephropathy. No safety and tolerability issues were identified", said CEO professor Eva Steiness.
A statistically significant reduction in urine protein excretion from baseline was observed in both the high and low dose groups after only 30 days of treatment, and a very strong trend towards reduction was observed compared to placebo treatment.
SER150 has now passed an important milestone in development for treatment of this devastating condition in patients with diabetes. Serodus will continue the planning of the subsequent Phase 2b dose finding study.”
In the randomized double-blind placebo controlled Phase 2a study two active doses of 15 and 30mg twice daily were administered orally to patients for one month. 74 patients participated in the study at 10 centers in Germany. No safety issues, biochemical abnormalities or bleeding tendencies were identified. Adverse events were evenly distributed between the active and placebo groups and mild to moderate in intensity.
SER150 is an anti-inflammatory compound with a novel mode of action both inhibiting thromboxane synthase as well as blocking the thromboxane receptor. SER150 is expected to specifically inhibit or stop the inflammatory processes in the renal arterioles and glomeruli and halt the progression of renal impairment whereby the amount of protein excreted in urine will decrease or cease.
Serodus is a drug development company, focusing on new therapeutic products for treatment of diabetes and diabetic comorbidities. For more information, please contact CEO Eva Steiness on firstname.lastname@example.org, or CFO Tore Kvam at email@example.com, mobile +47 95934199.