T20K MS clinical trial : Swedish biotech company Cyxone said that a phase 1 clinical trial for its drug candidate T20K for multiple sclerosis (MS) has confirmed its safety and tolerability in humans.
Cyxone said that there were no serious adverse events in the early-stage infusion study. As the next step in its development program, T20K will be prepared as an oral formulation after which there will be another phase 1 MS clinical trial.
According to the Swedish biotech company, T20K’s pharmacokinetic values could be established by measuring the amount of substance in the study subjects’ blood. The pharmacokinetic values give knowledge of what the human body does to the investigational MS drug, said Cyxone, referring to the movement of the substance into, through, and out of the body.
Commenting on the T20K MS clinical trial results, Kjell G. Stenberg – CEO of Cyxone, said: “There is always an element of uncertainty when taking a new substance to man despite successful testing in several animal species. To our great delight, the results were far above our expectations already after the first, lowest, dose level reinforcing our conviction of T20K’s exceptional potential.”
Cyxone said that phase 1 T20K MS clinical trial was intended to be made up of one cohort of eight healthy male volunteers subjected to a very low dose of T20K, 0.005 mg per kilo, if it was not feasible to measure the level of the drug candidate in the blood at this stage, a second cohort with a higher dose level would be given. Depending on the results from the first dose level achieving the objective of the first-in-human study, a higher dose level will not be required to be studied, said the Swedish biotech company.