Serodus announces completion of patient enrollment of the first cohort in Phase 2a clinical trial of SER150 in patients with Diabetic Nephropathy
Oslo, February 3, 2016: Serodus (Oslo Axess: SER), today announced that the last patient in the first cohort was randomized into the SER150 multi-center, double-blind, randomized, placebo controlled Phase 2a clinical trial in patients suffering from Diabetic nephropathy. SER150 is a first-in-class anti-inflammatory compound, with a dual thromboxane (anti thrombotic) mode of action.
The Phase 2a, safety and tolerability trial is expected to enroll up to a total of 76 patients, randomized in two sequential cohorts of 36 patients. The first cohort is treated with 15mg SER150 twice daily and the second cohort will be treated with 30mg SER150 twice daily. A 2:1 active-to-placebo design is used for randomization to either SER150 or placebo treatment which will add up to 24 patient on each of the doses given and 24 patients given placebo. The primary endpoint will be safety and tolerability of SER150. Secondary endpoints will include proteinuria and measurement of urinary thromboxane as a marker of the inflammatory process. All the 36 patients of the first study cohort were enrolled according to the study protocol.
"The completion of the first cohort of patients in this study shows the momentum of the trial, and represents an important milestone for Serodus and for patients suffering from Diabetic nephropathy," said Eva Steiness, Professor, Chief Executive Officer of Serodus. “We believe SER150 has the potential to improve treatment of nephropathy in diabetic patients”.
For more information contact:
CFO, Serodus ASA
Mobile: +47 959 34 199
Serodus ASA is a drug development company listed on Oslo Stock Exchange, focusing on new therapeutic products for the treatment of cardiovascular and metabolic diseases with large unmet clinical needs. The company's business model is to seek partnering with international pharmaceutical companies after having demonstrated clinical effect in humans. For more information see www.serodus.