Cereno Scientific submits Clinical Trial Application (CTA) for first-in-human Phase I study with novel epigenetic HDACi drug candidate CS014
Cereno Scientific (Nasdaq First North: CRNO B), a pioneering biotech developing innovative treatments for rare and common cardiovascular disease, today announced the submission of a clinical trial application (CTA) to the European Medicines Agency (EMA) for a first-in-human, Phase I study of novel histone deacetylase inhibitor (HDACi) drug candidate CS014.
The CTA was submitted for a first in human Phase I study to primarily evaluate the safety and tolerability of CS014 in healthy volunteers. The design is a traditional single ascending and multiple ascending dose study for 1 week. Title of the study is “A first-in-human, open-label trial to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of CS014 in healthy volunteers after single and multiple administration”. More information will be available on ClinicalTrials.gov when the study is approved by the regulatory authorities.
“I am pleased to announce that we have taken further steps towards evaluating CS014 in thrombosis prevention, by submitting a CTA to EMA for approval. The CTA, once approved, will allow us to initiate the first trial in man with CS014 and marks important progress in our efforts to in the future prevent thrombosis in patients”, said Sten R. Sörensen, CEO, Cereno Scientific.
“The R&D team at Cereno Scientific has worked intensely with performing and documenting the preclinical efficacy and safety studies of CS014 for several years and this CTA marks an important milestone for the team and for Cereno as a company. Once approved, we look forward to initiating the Phase I study in a timely manner”, said Nicholas Oakes, Head of Preclinical Development, Cereno Scientific.
The Phase I study is planned to be initiated during Q2 2024.
About the Novel HDACi CS014
The investigational drug candidate CS014 belongs to Cereno’s HDAC inhibitor program, capitalizing on the principle of epigenetic modulation.
The innovative drug candidate represents a novel approach to antithrombotic treatment without the associated increased risk of bleeding in humans. CS014 is a new chemical entity with a multi-modal mechanism of action as an epigenetic modulator – regulating platelet activity, local fibrinolysis, and clot stability for the prevention of thrombosis without increasing the risk of bleeding, as documented in preclinical studies. Given the potential for the disease-modifying properties seen with HDAC inhibition, additional cardiovascular benefits of CS014 may be expected, including amelioration of inflammation, fibrosis, vascular changes and elevated blood pressure. HDAC inhibition as thrombosis prevention has the opportunity to fundamentally change the thrombosis prevention landscape and meet a major unmet medical need. CS014 is being developed in collaboration with the University of Michigan.
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 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 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 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 several preclinical studies to target the IP receptor for prevention of thrombosis without increased risk of bleeding, which also has been recognized in the medical community. CS585 was in-licensed from the University of Michigan in 2023. 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.