Cereno Scientific completes preclinical safety program for innovative drug candidate CS014 targeting thrombosis prevention and reaches a major preparatory milestone towards the Phase I study

“This is a great milestone for our preclinical CS014 program. We are excited to now have moved closer to the next significant step in CS014’s development path, i.e. to test our drug candidate for the first time in humans. Based on results from animal studies, our novel HDACi CS014 has shown great potential. This innovative drug candidate represents a groundbreaking novel approach to antithrombotic treatment so far shown to be without the associated increased risk of bleeding,” said Sten R. Sörensen, CEO at Cereno Scientific.


Drug candidate CS014 is a histone deacetylase inhibitor (HDACi) in development as a treatment for arterial and venous thrombosis prevention. This innovative drug candidate represents a groundbreaking approach to antithrombotic treatment so far shown to be without the associated increased risk of bleeding. The preparations before a Phase I study can be initiated includes completion of the preclinical development program, including a preclinical safety program, development and manufacturing of the investigational formulation used for oral dosing of the healthy volunteers and obtaining permission from the Swedish Medical Products Agency as well as the Ethics Committee to start the study. The Phase I study is estimated to be initiated in the first half of 2024.


For further information, please contact:

Tove Bergenholt, Director IR & Communications

Email: tove.bergenholt@cerenoscientific.com

Phone: +46 732-366 246

 

Sten R. Sörensen, CEO

Email: sten.sorensen@cerenoscientific.com

Phone: +46 73-374 03 74

 

About CS014

The investigational drug CS014 is a histone deacetylase inhibitor (HDACi) in development as a treatment for arterial and venous thrombosis prevention. This innovative drug candidate represents a groundbreaking approach to antithrombotic treatment potentially without the associated increased risk of bleeding in humans. The drug candidate 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 increased risk of bleeding. In preclinical studies, CS014 demonstrates inhibition of clot formation following platelet injury by significantly attenuating platelet activation and reducing fibrin formation at the injury site. CS014 potentially offers a significantly lower risk of bleeding compared to other novel oral anticoagulants, as validated in preclinical studies. CS014’s safety and tolerability will be further assessed in the Phase I study planned to be initiated in H1 2024.

About Cereno Scientific AB

Cereno Scientific develops innovative treatments for common and rare cardiovascular disease. The lead drug candidate, CS1, is a 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 study is ongoing to evaluate CS1’s safety, tolerability, and efficacy in patients with the rare disease pulmonary arterial hypertension (PAH). A collaboration agreement with global healthcare company Abbott allows Cereno to use their cutting-edge technology CardioMEMS HF System in the study. Two initiatives performed during the ongoing Phase II study 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 study results that are expected in Q2 2024. Cereno also has two promising preclinical drug candidates in development through research collaborations with the University of Michigan. Investigational drug CS014 is a HDAC inhibitor in development as a treatment for arterial and venous thrombosis prevention. The innovative drug candidate represents a groundbreaking approach to antithrombotic treatment potentially without the associated increased risk of bleeding in humans. 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 increased risk of bleeding as documented in preclinical studies. Drug candidate CS585 is a prostacyclin receptor agonist that 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 Nasdaq First North (CRNO B). More information on www.cerenoscientific.com.

 

Datum 2023-12-01, kl 11:00
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