Cereno Scientific presents positive results from the first clinical study with CS1
The analysis of Cereno Scientific’s first clinical study with CS1 has been concluded, with positive results regarding safety, pharmacokinetic properties and effect on biomarker for the risk of thrombosis.
“It is very satisfying for us to have demonstrated the expected properties for CS1 in a clinical study as well. With this convincing safety profile, and favourable data as regards the release profile and effects on the PAI-1 biomarker, we feel comfortable in pursuing development forward and defining the continued clinical programme,” says Cereno Scientific’s CEO Sten R. Sörensen.
The study was conducted in collaboration with CTC, Cereno Scientific’s clinical research partner in Uppsala. Thirty individuals took part in the study to evaluate safety, the pharmacokinetic properties of the drug and the effect on PAI-1, the biomarker for the risk of thrombosis. The study contained single and repeated doses of CS1 at two dosage levels.
The formal analysis of the results shows that CS1 is well tolerated, with a positive side effect profile. The release profile is optimised for preventive treatment of thrombosis and highly reproducible. At the same time, the data show that treatment with CS1 significantly lowers PAI-1 levels. PAI-1 is the factor that inhibits t-PA, which is the substance the body itself uses to dissolve blood clots. The concentration of PAI-1 varies over a 24-hour period, and when PAI-1 levels in the blood are highest, the risk of suffering a heart attack and/or stroke is greatest. It is well known that elevated levels of PAI-1 in the blood represent an important and significant risk factor for cardiovascular disease.
In previous pre-clinical studies, Cereno Scientific showed that in addition to the normalising effects on t-PA production, administering the active substance in CS1 results in a reduction of PAI-1 levels, which has now also been confirmed in the first clinical study. The discovery is a unique one, and opens up the possibility of developing a new CS1 drug with a double mechanism of action for an optimised clot-busting effect. Next step is to initiate a phase II study to investigate the antithrombotic effects of CS1 and the company recently signed a Letter of Intent with the leading CRO partner OCT about a collaboration to conduct the study.
Cereno Scientific is developing an improved treatment for protection against blood clots (thrombosis), the leading cause of death in the world. The company’s drug candidate, CS1, is being developed for preventive treatment of thrombosis-related illnesses. The new drug, which is based on a new mechanism of action, is expected to provide effective treatment and a lower risk of bleeding side effects than current treatments with blood thinners.
The therapeutic potential of CS1 as a new treatment for preventing thrombosis has been demonstrated in various pre-clinical studies. The new results from the first clinical study indicate that CS1 has the potential to become a new treatment alternative for reducing thrombosis formation by stimulating fibrinolysis, which is the body’s own defence against thrombosis.
About Cereno Scientific AB
Cereno Scientific is developing a novel preventive medicine to treat thrombosis-related disease, based on the body’s own intelligent clot-busting system. Cardiovascular disease is currently the leading cause of death worldwide. Current therapies are connected to an increased risk of bleeding and, as a result, low effectiveness due to lower dosing levels. In turn, this leads to a high risk of new blood clots. Cereno Scientific’s drug candidate, CS1, is expected to provide a possibility for an effective prevention of thrombosis and a lower risk for serious bleeding complications than with current blood thinning therapies. CS1 is a controlled release formulation of a known compound and, as such, is expected to have a relatively short development time. The Gothenburg-based company is located in AstraZeneca’s BioVentureHub and is supported by GU Ventures. Cereno Scientific’s B share has been listed on Spotlight Stock Market since June 2016 with the ticker CRNO B, ISIN SE0008241558.
This information is such that Cereno Scientific AB is required to make public in accordance with the EU’s market abuse regulation (MAR). The information was made available publically by the Company’s contact person on June 28th 2018.