Oslo, Norway – November 7, 2017 – Serodus ASA yesterday received a notice from the European Patent Office that the opposition period (a nine months period post-grant of the patent) expired for the SER130 Composition of Matter patent granted to University of Copenhagen and licensed to Serodus 16 December 2008, and no opposition to the patent was filed.
Serodus requested a Pre-Investigational New Drug (pre-IND) meeting with the Food and Drug Administration (FDA), USA. The objective is to receive guidance for the development path for the lead compound SER150 in patient with Diabetic Nephropathy. Serodus is proud to announce that the meeting has been granted and will be held ultimo September 2017. The aim of the meeting is to discuss the future development plan in the US for SER150. Similar meeting will be planned in Europe
Strong results of the Phase 2a study for SER150 in Diabetic Nephropathy was announced:
- Serodus is planning to publish the details of the findings from the study later in 2017
- Results are currently being presented to potential partners, investors and scientific advisors
- Serodus is preparing for a pre-IND meeting
Serodus was delisted from Oslo Stock Exchange and is now a private company.
The company completed the subscription of a convertible loan of 25 MNOK Serodus is currently focussing all resources on SER150 for the treatment of patients with diabetic nephropathy
Serodus announced on January 2nd 2017 the very positive outcome of that SER150 study. The drug candidate was well tolerated and statistical significant improvement on a relevant biomarker for kidney function was found. Based on these findings Serodus is now preparing for a meeting with the US regulatory authorities (FDA), a so called pre-IND meeting. Here the continuous development strategy for SER150 will be discussed.
Oslo, 28 February 2017. Serodus announce the fourth quarter results.
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.