Date: 2015-06-15
Type of information: Initiation of preclinical development
phase: 2a
Announcement: clinical trial authorization
Company: Serodus (Norway)
Product: SER150
Action
mechanism: antiinflammatory agent. SER150 is a first-in-class anti-inflammatory compound, with a dual anti thrombotic mode of action. SER150 is both inhibiting thromboxane synthase as well as blocking the thromboxane receptor. SER150 is expected to specifically inhibit the inflammatory processes in the renal arterioles and glomeruli and reduce the progression of renal impairment whereby the amount of protein excreted in urine will decrease.
Disease: diabetic nephropathy
Therapeutic area: Metabolic diseases - Renal diseases - Kidney diseases
Country: Germany
Trial
details: 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.
Latest
news: * On January 2, 2017, Serodus 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. 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. Serodus will continue the planning of the subsequent Phase 2b dose finding study. * On November 28, 2016, Serodus announced that the Phase 2a study of SER150 in diabetic nephropathy completed enrollment with the last patient in cohort2 being dosed the last dose. * On June 20, 2016, Serodus announced that the company has randomized the first patient into the second and last cohort of the SER150 study in diabetic nephropathy. Patients are dosed with 30mg SER150 twice daily for one month followed by one month of follow up. After the approval from by the independent Data Safety Monitoring Board (DSMB) and the ethical committee in the beginning of June patients have been screened and now the first patient randomized. * On June 1, 2016, Serodus received approval from the central German Ethics committee to initiate recruitment into the second cohort of the SER150 study in diabetic nephropathy. This follows the recent approval by the independent Data Safety Monitoring Board (DSMB). All ten participating sites in Germany may now initiate screening activities in the second cohort of the trial where SER150 will be dosed twice daily with capsules containing 30mg to patients with diabetic nephropathy. * On May 13, 2016, Serodus announced that the Data Safety Monitoring Board (DSMB) has issued a positive recommendation regarding the data from cohort 1 of the ongoing Ph2a study of SER150 in diabetic nephropathy. * On February 3, 2016, Serodus 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. All the 36 patients of the first study cohort were enrolled according to the study protocol. * On August 13, 2015, Serodus announced that the first patients are randomized in the SER150 multi-center, double-blind, randomized, placebo controlled Phase IIa clinical trial in patients suffering from diabetic nephropathy. The Phase IIa, safety and tolerability trial is expected to enroll up to total 76 patients, randomized in a 2:1 ratio to either SER150 or placebo treatment. 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. * On June 15, 2015, Serodus announced that the company received approval for a Clinical Trial Application from the German Federal Institute for Drugs and Medical Devices (BfArM) to commence a Phase IIa safety study with SER150 in patients diagnosed with diabetic nephropathy. The study will be running during 2015 and 2016. Serodus expects interim safety results from the first cohort end 2015 and final data second half of 2016. * On February 18, 2015, Serodus annonced that the company has filed a Clinical Trial Application with the German authorities for a Phase IIa study on SER150 diabetic nephropathy. Serodus expects that the study will be running during 2015 and 2016.
The positive opinion of the DSMB will now be sent to the regional Ethics Committee for their approval upon which Cohorte 2 dosing SER150 at 30mg twice daily may start enrollment. The DSMB has recommended that recruitment of patients to cohort 2 can be initiated. The total number of patients in this study will be 72.
