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Land | Sverige |
---|---|
Lista | Mid Cap Stockholm |
Sektor | Hälsovård |
Industri | Bioteknik |
Cinclus Pharma, a clinical-stage pharmaceutical company developing molecules for the treatment of acid-related diseases, announces today that the manufacturing of the Investigational Medicinal Product (IMP), to be used for the company's upcoming phase III study of linaprazan glurate for eGERD, has been successfully completed. Thus, the company is following its time plan for recruiting the first patient in 2025.
"This is the first time we are manufacturing our new formulation on a large scale, which is an important milestone to be able to start our phase III studies, especially given that it is a new formulation that has not been manufactured on a large scale before. Today's announcement bodes well for the future as the batch size is representative of a commercial batch and secures the coming commercial manufacturing. This also means that we are on track to be able to recruit the first patient in 2025," said Christer Ahlberg, CEO of Cinclus Pharma.
The manufacturing was done by Cinclus Pharma’s partner, the Swiss company Lonza, one of the world's leading contract development and manufacturing organizations (CDMO), at its site in Florida, USA.