Topic: Completion of a phase IA clinical trial of a drug based on an innovative JAK/ROCK inhibitor – CPL 409116
In relation to the current report No. 39/2020 of 12 November 2020 on receiving approval for a Phase I clinical trial of a drug based on an innovative JAK/ROCK inhibitor – CPL 409116 – in the treatment of autoimmune diseases, the Company wishes to announce that on February 9, 2021 it received information on the completion of a Phase IA clinical trial of the CPL’116 compound, a dual JAK/ROCK kinase inhibitor, administered once in various, increasing doses to healthy volunteers.
The study was designed to assess the safety profile and pharmacokinetic parameters of the compound. No adverse reactions related to the administration of the tested product were observed in the trial.
CPL’116, developed by the Company, is the first dual JAK and ROCK kinase inhibitor in the world and will be used in the treatment of selected autoimmune diseases in which the desired effect is simultaneous inhibition of inflammation and fibrogenesis.
The Company plans to initiate an IB trial in the upcoming weeks in which the compound will be administered repeatedly, at increasing doses, and the assessment will include not only the analysis of safety and pharmacokinetic parameters, but also the key pharmacodynamic parameters.