New preclinical data for Cereno Scientific’s novel IP Receptor Agonist CS585 presented at ESC Congress 2024
Cereno Scientific (Nasdaq First North: CRNO B), a pioneering biotech developing innovative treatments for rare and common cardiovascular disease, today announced new preclinical data indicating that drug candidate CS585, a novel prostacyclin (IP) receptor agonist, inhibits platelet activation and clot formation up to 24 hours post-administration. The new data was presented at the ESC (European Society of Cardiology) Congress 2024, on August 30–September 2, 2024.
CS585, was shown to inhibit platelet activation and clot formation in the blood up to 24 hours post administration. In both in vivo and ex vivo models, the sustained effects of CS585 were demonstrated. In contrast, currently FDA-approved IP receptor agonists were shown not to have sufficient duration of action to target the IP receptor for prevention of thrombus formation in blood. Therefore, CS585 represents a novel prostacyclin (IP) receptor agonist for antiplatelet treatment of thrombotic diseases.
The abstract titled “CS585, a novel prostacyclin receptor agonist, demonstrates sustained efficacy in vivo in the prevention of thrombosis”, was authored by L. Stanger1, A. Rickenberg1, M. Flores1, B. Dahlof2 and M. Holinstat1 (1 University of Michigan, Ann Arbor, United States of America; 2 Cereno Scientific, Gothenburg, Sweden). The abstract was presented, by Dr. Michael Holinstat, Professor at the Department of Pharmacology, the Department of Internal Medicine (Division of Cardiovascular Medicine), and the Department of Vascular Surgery at the University of Michigan. Dr. Holinstat leads Cereno’s preclinical work at the University of Michigan and is Director of Translational Research at Cereno.
Read the full abstract here and see Dr. Holinstat present the abstract here.
The purpose of the study was to assess the stability profile of CS585, an IV and orally bioavailable IP agonist, compared to FDA-approved IP agonists iloprost and selexipag, with regards to sustained activity in vivo in the blood in limiting platelet activation and thrombosis.
Blood drawn from mice administered CS585 was observed to show a decrease in platelet adhesion and clot formation. The effects of iloprost and selexipag are no longer observed at 24 hours post-administration. Administration of CS585 resulted in sustained inhibition of platelet accumulation and fibrin formation in the laser-induced cremaster arteriole thrombosis assay up to 18 hours post-administration. In mice administered iloprost, a decrease in thrombus formation was observed 10 minutes post-administration, but thrombus size returned to vehicle levels by 4 hours. Selexipag-dosed mice demonstrated inhibition of thrombus formation up to 4 hours, but effects were no longer observed at 18 hours.
“The current data in a preclinical model shows that IV administration of CS585 elicited full protection against thrombosis formation for the entire 18h window that was tested. Oral administration was shown to fully protect from thrombosis for 24 hours”, said Dr. Michael Holinstat.
“We are delighted to see additional preclinical data underlining the potential of Cereno’s novel IP receptor agonist CS585. This further adds to the growing body of evidence from Cereno Scientific’s preclinical research at University of Michigan supporting CS585 as a viable option for targeting the IP-receptor on platelets for inhibition of thrombosis with a reduced risk of bleeding”, said Sten R. Sörensen, CEO, Cereno Scientific.
About CS585
Drug candidate CS585 is an oral, highly potent, and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular disease. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension.
A license agreement for drug candidate CS585 with the University of Michigan provides Cereno exclusive rights to further development and commercialization of CS585.
In early November 2023, CS585 was highlighted by top-tier medical journal Blood as a promising novel anti-thrombotic strategy without risk of bleeding.
For further information, please contact:
Henrik Westdahl, Director IR & Communications
Email: henrik.westdahl@cerenoscientific.com
Phone: +46 70-817 59 96
Sten R. Sörensen, CEO
Email: sten.sorensen@cerenoscientific.com
Phone: +46 73-374 03 74
About Cereno Scientific AB
Cereno Scientific develops innovative treatments for rare and common cardiovascular disease. The lead drug candidate, CS1, is an HDAC (histone deacetylase) inhibitor that acts as an epigenetic modulator with pressure-reducing, reverse-remodeling, anti-inflammatory, anti-fibrotic and anti-thrombotic properties. A Phase II trial is ongoing (patient recruitment closed on July 1st, 2024) to evaluate CS1’s safety, tolerability, and exploratory efficacy in patients with the rare disease pulmonary arterial hypertension (PAH). The study will also provide insights for planning the subsequent trial of CS1 in PAH. A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the trial. Two initiatives performed during the Phase II trial have shown positive findings suggesting the potential clinical benefit of CS1 in PAH patients. These initial findings are, however, not a guarantee of the final trial results that are expected in Q3 2024. Since January 2024, we are delighted that the FDA´s Expanded Access Program will enable patients with PAH, a serious life-threatening disease condition, to gain access to CS1 where no comparable alternative therapy options are available. Cereno’s pipeline comprises two additional programs in development through research collaborations with the University of Michigan. Investigational drug CS014 is an HDAC inhibitor in Phase I development as a treatment for arterial and venous thrombosis prevention. The innovative drug candidate represents a groundbreaking approach to antithrombotic treatment. CS014 is a new chemical entity with a multi-fold mechanism of action as an epigenetic modulator – regulating platelet activity, fibrinolysis, and clot stability for the prevention of thrombosis without an increased risk of bleeding as documented in preclinical trials. On 28th of June, 2024, Cereno initiated a first-in-human Phase I trial of CS014. Preclinical candidate CS585 is an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular disease. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. CS585 was in-licensed from the University of Michigan in 2023. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. Based in Kendall Square, Boston, Massachusetts, US. Cereno is listed on the Nasdaq First North (CRNO B). The Certified Advisor is Carnegie Investment Bank AB, CA@carnegie.se. More information is on http://www.cerenoscientific.com