First subject dosed in Cereno Scientifics first-in-human Phase I trial of novel 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 first subject has been dosed in first-in-human, Phase I, trial of novel HDAC inhibitor CS014, being developed as an innovative therapy for thrombosis prevention.
“We are delighted to announce that the first subject in the Phase 1 trial of CS014 has been dosed, marking the first step into clinic for this candidate. Cereno Scientific is determinedly progressing from strength to strength, and this latest important milestone of CS014 entering clinic takes us one step closer to be able to improve the lives of patients with thrombosis and other devastating cardiovascular diseases”, said Sten R. Sörensen, CEO, Cereno Scientific.
The Phase I trial CS014-001, titled “A First-in-human, Open-label Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CS014 in Healthy Volunteers After Single and Multiple Administration”, is conducted in partnership with the contract research organization (CRO) Clinical Trial Consultants AB (CTC), in Uppsala, Sweden.
The trial is a Phase I, open-label, FIH trial designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending oral doses of CS014 in healthy volunteers. The trial will be conducted in two parts:
- A single ascending dose (SAD) part (Part I) will explore safety, tolerability and PK of single ascending oral doses of CS014.
- A multiple ascending dose (MAD) part (Part II) will explore safety, tolerability, PK, and PD following multiple ascending doses of CS014, dosed for seven days.
The Phase I trial of CS014 will include around 48 subjects and results are expected in a year’s time.
More information about the trial can be found on the EU clinical trials website under the EUCT number 2024-510878-24-00. Information will also be available shortly on clinicaltrials.gov.
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 an 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 remodeling and elevated blood pressure. HDAC inhibition as a therapy to avoid thrombosis 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
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 trial. 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’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 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). The Certified Advisor is Carnegie Investment Bank AB, CA@carnegie.se. More information is on www.cerenoscientific.com.