Serodus announces positive opinion from Data Safety Monitoring Board on SER150 Ph2a study
Serodus (Oslo Axess: SER) today 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. The Chairman of the DSMB, Professor Dr Christoph Wanner stated: ”The DSMB has no safety concerns”. The DSMB reviewing all data from the ongoing trial at 10 sites in Germany. Special emphasis was placed on the safety profile of the drug.
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 ongoing Phase 2a SER150 for Diabetic Nephropathy study is a safety study which evaluate safety parameters and whether patients with diabetic nephropathy tolerate the compound. The study is carried out in patients with proteinuria, the marker of nephropathy in patients with diabetes. The study is divided in two parts, cohort 1 who receive 15 mg twice daily or placebo and cohort 2 who receive 30mg SER150 twice daily or placebo. The DSMB has today recommended that recruitment of patients to cohort 2 can be initiated. The total number of patients in this study will be 72.
”We are very pleased to learn of the positive recommendation by the DSMB. This means that a safe dose of SER150 has been established in the patient population with diabetic nephropathy, and the study may now progress according to schedule. We expect the study to complete enrollment during the summer upon which a decision regarding a subsequent Ph2b dose-finding study may be made.” said CEO Dr Eva Steiness.
SER150 is an anti-inflammatory compound with a novel mode of action both inhibiting thromboxane synthase as well as blocking the thromboxane (TP) 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. Treatment with ACE-inhibiting anti-hypertensives is the gold standard treatment in diabetic nephropathy. However, this treatment does not inhibit the fundamental causes of renal damage, nor does it cure the disease.
Serodus ASA is a drug development company, focusing on new therapeutic products for the treatment of metabolic and cardiovascular 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.com.
This release is an announcement issued pursuant to legal information obligations, and is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act. It is issued for information purposes only, and does not constitute or form part of any offer or solicitation to purchase or subscribe for securities, in the United States or in any other jurisdiction.