The company has announced the initiation of key preclinical studies required to enable taking its Multiple Sclerosis drug candidate T20K forward.
Firstly, the company will select a Contract Manufacturing Organization (CMO) to establish a new manufacturing process to produce larger quantities of GMP (Good Manufacturing Practice) grade material needed in further preclinical and clinical studies, it states in a press release. Furthermore, while Cyxone continues to develop the oral administration form for T20K, the company has also decided to initiate a feasibility study on a subcutaneous administration form in Q2 2021. Finally, biomarker development to support both administration forms will be completed.
“We are now in the position to select a partner and initiate this critical step”
“We have spent the past year exploring different options for the manufacture of T20K and are now in the position to select a partner and initiate this critical step. The outcome of this study aims to provide Cyxone with an outline for a robust, scalable manufacturing process for the drug substance in more than sufficient amounts as required to further progress the T20K program,” says Tara Heitner, CEO. “The initiation of studies in alternative administration forms and biomarker development for T20K will also serve to de-risk drug development and help support transition to clinical studies. I am very pleased with the progress the company has made in the past year.”
Photo of Tara Heitner, CEO, Cyxone