Biopharmaceutical company Cereno Scientific has announced a partnership with CordenPharma to scale up manufacturing of its drug candidate CS1.
The move is in preparation for the next clinical trial phase and potential market launch and meets the demands of an extended access programme, should the US Food and Drug Administration (FDA) grant approval.
Contract development and manufacturing organisation CordenPharma will be responsible for producing larger quantities of CS1.
This will ensure an adequate supply of the drug for the upcoming clinical trial and for the treatment of pulmonary arterial hypertension (PAH) patients under the compassionate use programme.
Cereno Scientific CEO Sten Sörensen stated: “This is a key milestone for Cereno, marking a starting step of our pivotal clinical trial programme, which we anticipate to be pursued after our currently ongoing Phase II study in PAH.
“With often long lead times in drug development, we are with this agreement ensuring that there will be a supply of CS1 when we are ready to initiate the next clinical trial with CS1. With this contract, we are also securing long-term availability of CS1 supply for the extended access that was requested from the FDA last week.
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“Now we can be assured that there is a continuous supply of CS1 available for the patients who are to continue treatment after the Phase II study.”
Cereno is recruiting patients at ten specialist clinics across the US for the Phase II study of CS1.
A request for expanded access to CS1 was submitted to the US FDA on 3 January 2024, following inquiries from investigators involved in the study.
The Phase II study will randomise 30 PAH patients, with top-line results to be reported in the second quarter of 2024.
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