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Cereno Scientific (XSAT: CRNO B) today announced that the first patient has received their first dose of drug candidate CS1 in the Phase II study in pulmonary arterial hypertension (PAH). Prior to the dosing, the patient has undergone a screening process, implantation of the CardioMEMS HF System to monitor lung pressure during the study, and a full baseline evaluation including a 6-minute walk test, echocardiography, and MRI to enable exploration of CS1's efficacy. Each patient will undergo a 12-week drug treatment period and a two-week follow-up period. Drug candidate CS1 aims to offer a disease-modifying treatment that has better efficacy and is safer compared with current treatment options for patients living with the rare disease PAH.
"I am glad to see the first patient dosed in the Phase II study with CS1 in PAH. It truly is a great milestone in CS1's clinical development plan. We look forward to progressing and keeping momentum throughout the study. PAH is a debilitating disease with a great need for new, disease-modifying treatments, which do not exist on the market today. We aim to be able to, in the future, offer patients living with PAH an opportunity for an improved and longer life," says Sten R. Sörensen, CEO at Cereno Scientific.
In March 2020, Cereno received the US FDA's orphan drug designation (ODD) for the clinical development program for CS1 in PAH. Through the granted ODD, the FDA has indicated that they believe CS1 has the potential to provide significant benefit to patients suffering from PAH. In September 2021, an investigational drug application (IND) was accepted by the FDA to start a Phase II multi-center PAH study in the US. Since then, many activities and processes have been executed culminating in the activation of clinical sites participating in the study and the subsequent patient enrollment. The study aims to report top-line results in Q1 2023.
For further information, please contact:
Daniel Brodén, CFO
Phone: +46 768 66 77 87
About the Phase II study with CS1 in PAH
CS1 was granted an orphan drug designation (ODD) for the treatment of the rare disease PAH by the US FDA in March 2020 and in September 2021, Cereno obtained FDA acceptance of an investigational new drug (IND) application allowing initiation of the Phase II study. This study intends to evaluate drug candidate CS1's safety, tolerability, dose, and exploratory efficacy in patients with PAH. A collaboration agreement with global healthcare company Abbott allows Cereno to use Abbott's cutting-edge technology CardioMEMS HF System in the study. There will be a 12-week drug treatment period and a two-week follow-up period. The primary endpoint is safety and tolerability. All standard efficacy endpoints for this patient group will be explored as well as validated risk scores before and after treatment. The study includes at least ten different clinical sites in the US and aim to include 30 patients with PAH. Further information is available at https://www.clinicaltrials.gov/(ClinicalTrials.gov identifier NCT05224531).
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 CS585 is a stable, selective, and potent prostacyclin receptor agonist. In preclinical studies CS585 has been documented to target the IP receptor for prevention of thrombosis without increased risk of bleeding. Drug candidate CS014 is a novel HDAC inhibitor with epigenetic effects. In preclinical studies CS014 has been documented to regulate platelet activity, ﬁbrinolysis and clot stability for prevention of thrombosis without increased risk of bleeding. Cereno Scientific 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 Swedish Spotlight Stock Market (CRNO B). More information on www.cerenoscientific.com.