Cereno Scientific signs CRO to conduct Phase I study of drug candidate CS014
Cereno Scientific (Nasdaq First North: CRNO B), a company developing innovative treatments for common and rare cardiovascular disease, today announced that an agreement has been signed with the contract research organization (CRO) Clinical Trial Consultants (CTC) to conduct the Phase I study of CS014. CTC will also provide support in the Phase I preparatory steps including study protocol development and clinical trial application process for the study which will be conducted in Sweden. This first-in-human Phase I study is planned to be initiated during the first half of 2024.
"We are very pleased to again work with CTC following the successful collaboration on a previous Phase I study with our drug candidate CS1. The CRO CTC is a competent partner with extensive experience in conducting Phase I and Phase II studies in cardiovascular disease and has an extended clinical site network. We are excited for this significant next step in CS014's development path: to test the 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 without the associated increased risk of bleeding," said Sten R. Sörensen, CEO at Cereno Scientific.
"We are very honored to once again support Cereno Scientific in advancing innovative treatments for preventing thrombosis. Our expertise in Phase I and Phase II studies, along with our extensive clinical site network, positions us well to support the development of CS014. We look forward to contributing to the success of this important first-in-human Phase I study," said Anders Millerhovf, CEO at CTC.
The collaboration with CTC starts immediately. The preparation before this Phase I study can be initiated includes completion of the preclinical development program, development and manufacturing of the investigational medical product 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.
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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 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, selected for prevention of thrombosis as target indication. 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 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.