Cereno Scientific selects prevention of thrombosis as target indication for its candidate drug CS014

Cereno Scientific (XSAT: CRNO B) today announced that the company’s preclinical drug candidate CS014 will continue toward clinical development for thrombosis prevention. CS014, a novel HDAC inhibitor with epigenetic effects, has, in preclinical studies, demonstrated anti-thrombotic properties supporting the selection of target indications with the aim of preventing thrombosis. The drug candidate is currently in the final stages of its preclinical development program, and a Phase I study is expected to start in 2024.

“CS014 has demonstrated promising anti-thrombotic properties in its ongoing preclinical program, both in relation to the prevention of venous and arterial thrombosis for further clinical development, which has been previously communicated at the ESC Congress 2022. The safety profile for CS014 has been shown to be favorable as it does not increase the risk of bleeding in preclinical studies. This is a much sought-after property for anti-thrombotic treatments as there is currently no therapy with such a profile available for patients in need of anti-thrombotic therapy. The preclinical program with CS014 is in its final stages of mandatory toxicological studies with preparations for first-in-man studies ongoing in parallel. If all goes according to plan, a Phase I study with CS014 is scheduled in the first half of 2024,” says Björn Dahlöf, Chief Medical Officer at Cereno

Drug candidate CS014 stems from Cereno’s preclinical HDACi (Histone DeAcetylase inhibitor) Program and acts as an epigenetic modulator. Epigenetic modulation is a novel approach in cardiovascular disease and results in a change in gene expression without an actual alteration of the genetic material. Since HDACs are found in most cells throughout the body, activation of these can lead to changes in how a person’s genes are expressed within the cells. This can affect key cellular pathophysiological mechanisms and thus increase the risk of disease. Using an HDAC inhibitor, such as CS014, disease-causing epigenetic changes can be modulated.

“I am pleased to announce that we have decided to initially focus our clinical development of CS014 as a treatment for the prevention of thrombosis. This enables the development team to effectively design the final stages of the preclinical program in preparation for
Phase I studies. Venous thromboembolism and arterial thrombosis in stroke and MI are affecting many patients every year; thrombosis, being behind most cardiovascular complications, is the number one killer in the world. As we have now narrowed our focus from cardiovascular disease in general to thrombosis, further preclinical and clinical studies will be key in deciding the initial thrombosis indication. The first indication will be one where CS014 is deemed to have the highest potential to deliver on the high unmet patient need of a more effective anti-thrombotic treatment without bleeding,” says Sten R. Sörensen, CEO at Cereno.

The preclinical development program for CS014 is currently ongoing in a research collaboration with the University of Michigan, Ann Arbor, US. CS014 was acquired from Emeriti Bio in March 2019 and has since been developed in a collaboration between Cereno and Emeriti Bio. A Phase I study of CS014 in healthy volunteers is expected to start in 2024.

For further information, please contact:

Josefine Göranson, Head of IR & Communication
Phone: +46 704 92 35 63
Email: info@cerenoscientific.com
http://www.cerenoscientific.com/

About Cereno Scientific AB

Cereno Scientific is a clinical-stage biotech company within cardiovascular diseases. The lead drug candidate, CS1, is a Phase II candidate in development for the treatment of the rare disease pulmonary arterial hypertension (PAH). 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, all relevant for PAH. A clinical Phase II study is ongoing to evaluate CS1’s safety, tolerability, and efficacy in patients with PAH. A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the study. Cereno also has two promising preclinical drug candidates in development for cardiovascular disease through research collaborations with the University of Michigan. Drug candidate CS014 is a novel HDAC inhibitor with epigenetic effects. In preclinical studies it has been documented to regulate platelet activity, fibrinolysis and clot stability for prevention of thrombosis without increased risk of bleeding. Thrombosis prevention in venous or arterial and cardiovascular disease has been selected as the first indication area for CS014. Drug candidate CS585 is a stable, selective, and potent prostacyclin receptor agonist. It has been documented in preclinical studies to target the IP receptor for prevention of thrombosis without increased risk of bleeding. The company is headquartered in Gothenburg, Sweden, and has a US subsidiary Cereno Scientific Inc. based in Kendall Square in Boston, Massachusetts, US. Cereno is listed on the Swedish Spotlight Stock Market (CRNO B). More information on www.cerenoscientific.com.