Cereno Scientific is emerging as a leading company in epigenetic modulation in cardiovascular diseases thanks to the development of CS1, a drug based on a reformulation of the effective HDAC (Histone DeACytlase) inhibitor valproic acid. Valproic acid acts as an epigenetic modulator with antithrombotic, anti-inflammatory, anti-fibrotic and pressure-relieving properties, all properties that are relevant for the treatment of a number of cardiovascular diseases.
The company is now focusing on planning for a Phase II clinical trial of CS1 in patients suffering from the rare disease pulmonary arterial hypertension (PAH). In January, Cereno Scientific initiated a cooperation with the Contract Research Organization (CRO) Worldwide Clinical Trials for support and guidance in the final preparatory steps for the clinical trial and its implementation. The clinical phase II study in PAH is expected to start in mid-2021, under the orphan drug classification that FDA has granted.
Option agreement with the University of Michigan
While preparations for the Phase II trial are underway, the company is looking at new opportunities for its development pipeline in CVD and expanding its preclinical development program. These so-called new chemical entities (NCEs) have been developed in-house and have been initially evaluated by University of Michigan in Ann Arbor, USA, in a collaboration that was established during the summer of 2020. The studies are led by Dr. Michael Holinstat, whose team is evaluating the substances both in vitro and in vivo with a primary focus on antithrombotic properties.
Last week, the collaboration bore new fruit when Cereno Scientific announced that it had signed an option agreement with the University of Michigan, in which the company receives exclusive rights to evaluate the market potential of a new preclinical drug candidate discovered by researchers at the university.
The agreement also gives Cereno Scientific the right to conduct further preclinical evaluations for a period of up to 27 months. After that, if the evaluation is successful, the company can exclusively license the drug for further clinical development with global rights for commercialization. Cereno Scientific CEO Sten R. Sörensen commented in a press release:
»We are pleased to enter into this agreement with the University of Michigan following our initial evaluation of this promising drug candidate. This fits well with our strategy to develop new treatments for common and rare cardiovascular diseases. We look forward to both getting this off the ground and the commercial value we believe it will bring to Cereno as the candidate successfully progresses through the drug development process.«
More details to follow
Cereno Scientific is expected to announce further details of the option agreement in the coming months, as well as more information about the company's preclinical programs as they develop. Overall, this represents an expansion of Cereno's project portfolio with another promising preclinical drug candidate in cardiovascular diseases.
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