July 21, 2020 

Staten Biotechnology, in collaboration with Novo Nordisk, starts dosing of anti-apoC3 antibody STT-5058 in First-in-Human Trial

Clinical trajectory initiated towards development of novel treatment for dyslipidaemia

Staten Biotechnology B.V. announced today the initiation of dosing of the Company’s lead asset, STT-5058, in a First-in-Human clinical study.

STT-5058 is a monoclonal antibody that targets the lipoprotein ApoC3 and is being developed in collaboration with Novo Nordisk. Staten Biotechnology and Novo Nordisk entered a collaboration and exclusive option agreement in December 2018 to develop novel therapeutics for the treatment of dyslipidaemia. Novo Nordisk is providing funding and support to Staten for the development of STT-5058 in this indication.

 Hilde Steineger, CEO of Staten Biotechnology, said: “Staten Biotechnology, with great support from Novo Nordisk, has been able to rapidly progress from research to product manufacturing to a clinical trial for our lead drug candidate. We are very excited to dose the first healthy volunteer.”

 Professor John Kastelein, Chief Medical Officer of Staten Biotechnology, added:
“The commencement of the FIH trial is an important milestone for the Company. We believe STT-5058, based on its favourable safety profile and novel mechanism targeting ApoC3, which is supported by human genetics, has the potential to address an unmet medical need in patients with mixed dyslipidaemia and high cardiovascular risk.”

December 17, 2018

Staten Biotechnology B.V. and Novo Nordisk A/S announce collaboration to develop novel treatment for dyslipidaemia

Staten Biotechnology B.V. and Novo Nordisk today announced that they have entered into a collaboration and exclusive option agreement to develop novel therapeutics for the treatment of hypertriglyceridaemia.

Under the collaboration agreement, Novo Nordisk will provide research and development (R&D) funding and support for Staten to develop its lead asset STT-5058 for treatment of dyslipidaemia.

"Novo Nordisk is joining forces with Staten Biotechnology at an exciting time for us, with the company's lead compound moving towards its first clinical trial, aiming to address the residual cardiovascular risk in patients with hypertriglyceridaemia," said Dr Hilde Steineger, CEO of Staten Biotechnology. "This partnership provides the company not only with a knowledgeable development partner but also with a funding structure that allows founders, management and the founding investors to accelerate the development of company". 

"Our partnership with Staten Biotechnology is a key step in executing our strategic priority to expand into cardiovascular diseases. Hypertriglyceridemia is a serious risk factor for cardiovascular disease, in particular often present in people with diabetes and obesity. Staten Biotechnology has developed STT-5058, a new promising concept validated by human genetics, for the treatment of hypertriglyceridemia. Combining Staten's know-how on STT-5058, the scientific excellence of the company's executive team and founders, with Novo Nordisk experience in drug development and commercialization, the project holds potential to make a real difference for people suffering from cardiovascular disease," said Marcus Schindler, Senior Vice President, Global Drug Discovery in Novo Nordisk.

Under the exclusive option agreement, Novo Nordisk has the right to acquire Staten Biotechnology and gain worldwide rights to STT-5058. Staten Biotechnology and its shareholders will potentially receive signing and exercise fees, R&D funding, and milestone payments of up to 430 million euros.

August 21, 2017

Staten Biotechnology announces publication in Nature Medicine of pre-clinical data supporting the therapeutic potential of its antibody STT-5058
in management of dyslipidemia

Staten Biotechnology (“Staten”), a company focused on the treatment of dyslipidemia and reduction of cardiovascular mortality, today announced a publication in Nature Medicine of pre-clinical data, supporting the therapeutic potential of STT-5058 in dyslipidemia management. 

March 3, 2017

Staten Biotechnology exercises option to develop therapeutic SIMPLE AntibodyTM for dyslipidemia from argenx N.V.

Staten Biotechnology, a company focused on the treatment of dyslipidemia and reduction of cardiovascular mortality today announced that it has exercised an exclusive option to license ARGX-116 (STT-5058), an anti-ApoC3 SIMPLE Antibody from argenx N.V.