A public-private consortium, made up of the biotech company Hemostatics, a member of CataloniaBio & HealthTech, the Clínica Universidad de Navarra (CUN) and the Institut Català d'Investigació Química (ICIQ), has obtained €2, 5 M€ from the Agència Estatal d'Investigació (AEI), in the framework of the call for grants for public-private collaboration projects, to accelerate the development of an innovative treatment aimed at controlling disabling and lethal haemorrhages.
The aim of the project, led by is the preclinical and clinical development of the antifibrinolytic agent CM-352, a first-in-class drug that represents a pioneering therapeutic approach to control acute bleeding in unmet medical needs, such as those associated with major surgery, trauma or intracranial haemorrhage (ICH).
"The socio-economic cost of acute seizures in trauma alone is enormous, and causes more than 6 million deaths a year, more than all infectious diseases combined, including COVID-19, malaria, tuberculosis, HIV / AIDS, etc. And it is responsible for a total cost of more than $670 billion dollars in the United States alone. However, we have yet to find an antihaemorrhagic agent that can address the unmet medical needs arising from severe haemorrhagic processes, and minimise the risk of potential side effects in the face of less severe haemorrhagic episodes," reveals Nicolas Saglio, CEO of Hemostatics. "Our CM-352 compound, in addition to reducing this important mortality and morbidity rate, will significantly reduce the healthcare costs derived from the annual expenditure on blood and transfusion-related activities.
"We already have experimental results indicating that CM-352 is highly effective in the main bleeding scenarios, with no signs of toxicity, thrombosis or secondary adverse effects. We will now complete the efficacy, toxicity, pharmacodynamic and pharmacokinetic studies in various preclinical models required by regulatory agencies. Obtaining these results will allow us to achieve a key milestone of the project: the approval of the health authorities to test CM-352 in a phase I clinical trial. Our initial focus will be the US FDA. Subsequently, we will also go to the EMA in Europe, and everything will be done in close collaboration with the Spanish agency, the AEMPS," explains Saglio.
The total capital raised to develop the compost now amounts to €3 million, including the 0.3 million received from the CDTI's Neotec programme in 2022, in addition to other private funds.
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