Cereno Scientific granted approval from EMA to initiate first-in-human Phase I trial with novel epigenetic HDAC inhibitor, CS014
Cereno Scientific (Nasdaq First North: CRNO B), a pioneering biotech developing innovative treatments for rare and common cardiovascular disease, today announced that the Clinical Trial Application (CTA) for a first-in-human, Phase I trial of novel histone deacetylase inhibitor (HDACi) drug candidate CS014, has been approved by the European Medicines Agency.
“Progressing CS014 from preclinical to a clinical stage marks a major achievement of our R&D Team. We look forward to exploring the future treatment possibilities based on the existing properties of the drug”, said Dr. Rahul Agrawal, Chief Medical Officer and Head of R&D, Cereno Scientific.
“CS014, an HDAC inhibitor with epigenetic effects, has shown potential in preclinical models of thrombosis, and other important CVDs and we are eager to now take this drug into the clinic and one step closer to patients”, said Nicholas Oakes, Head of Preclinical Development, Cereno Scientific.
“The approval of the CTA for CS014 by EMA is a key milestone for Cereno. After five years of dedicated hard work from our team to evaluate and document the preclinical safety and efficacy of this candidate drug we will now proceed to initiate the first-in-human Phase I trial, evaluating the safety of CS014 in healthy volunteers. This marks the beginning of the next phase in the Company’s growth journey, as we now will be advancing two clinical-stage candidates for patients with rare and common cardiovascular diseases”, said Sten R. Sörensen, CEO, Cereno Scientific.
The aim of the planned first-in-human Phase I trial is to evaluate the safety and tolerability of CS014 in healthy volunteers. The design is a single-ascending- and multiple-ascending-dose trial for 1 week. The 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 shortly.
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. 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 could 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
This information is information that Cereno Scientific AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 10:15 (CET) on June 18, 2024.
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 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 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 also has two promising preclinical drug candidates in development through research collaborations with the University of Michigan. Investigational drug CS014 is an 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 trials. In 2024, Cereno received approval from the EMA to conduct a first-in-human Phase I trial of CS014. Drug candidate CS585 is a prostacyclin receptor agonist. 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 Pulmonary Hypertension and thrombosis prevention without increased risk of bleeding. 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). Certified Advisor is Carnegie Investment Bank AB, CA@carnegie.se. More information on www.cerenoscientific.com.