A Paris-based biotech company has received priority medicines status from the European Medicines Agency (EMA) for a stroke drug.
The drug called glenzocimab is currently being evaluated in the phase two/three study in stroke patients.
The prime status allows reinforcement of support for the development of drugs that target an unmet medical need also allowing the company to strengthen interactions and get early dialogues with regulatory authorities to confirm the clinical development plan for the drug in the treatment of strokes.
Acticor Biotech obtained the US Food and Drug Administration’s Investigational New Drug (IND) programme for the study in November 2021. The move allowed the company to start human clinical trials and ship the experimental drug across state lines.
To date, 87 patients have already been enrolled in Europe and a total of 1,000 patients will be included both in the US and Europe.
“We are delighted that the European Medicines Agency has granted prime status to glenzocimab,” said Yannick Pletan, general manager of Acticor Biotech. “This designation is both a recognition of the significant unmet medical need for stroke and a validation of the relevance of the positive clinical results with glenzocimab in stroke patients.
“We will now be able to more easily pursue our discussions with regulatory authorities and ensure the smooth continuation of the phase two/three clinical trial, conducted in the US and Europe.”
Glenzocimab is being developed for use in the acute phase of ischaemic stroke as an add-on therapy to thrombolysis with or without mechanical thrombectomy.
The proposed administration regimen for glenzocimab is a six-hour intravenous infusion to cover the duration of the acute phase, being initiated within four and a half hours from the onset of stroke symptoms.
Acticor Biotech is a clinical stage biopharmaceutical company which aims to develop an innovative treatment for cardiovascular emergencies, including ischaemic stroke.
In June, the French company announced that the European Patent Office (EPO) had granted a new patent that provides protection for the use of glenzocimab in thrombotic diseases in Europe until 2036.
