Current Report 36/2021 – Successful completion of Phase I clinical trial of the CPL’116 compound, the world’s first dual JAK/ROCK inhibitor

Date: 08/10/2021, 3:12 pm

Legal basis: Article 17 section 1 of the Market Abuse Regulation (MAR) – confidential information.

In connection with current report 6/2021 on completing a Phase IA clinical trial of an innovative JAK/ROCK kinase inhibitor (CPL'116) with potential therapeutic efficacy in autoimmune diseases, the Company wishes to announce that on 08/09/2021 it received information on the completion of the administration of the studied compound CPL'116 to healthy volunteers in Phase IB clinical trial. This means the completion of the Phase I clinical trial for the compound.

In the above-mentioned phase, the study product was applied repeatedly (14 days), at increasing doses. The assessment, in addition to safety and pharmacokinetic parameters, included an analysis of key pharmacodynamic parameters related to the degree of JAK/ROCK kinase inhibition in biological material collected from healthy volunteers.

No serious adverse events (SAE) were observed in participants during the Phase IB trial, and the drug tolerability was high.

CPL'116 compound, developed by the Company, is the first dual JAK and ROCK kinase inhibitor in the world with anti-inflammatory and anti-fibrotic potential, which, should the molecule be successfully developed in subsequent phases of clinical trials, will contribute to significant therapeutic benefits not only in patients suffering from selected autoimmune diseases, but also in those with coexisting fibrotic lesions in essential organs.

The Management Board believes that the data and results collected in the Phase I trial provide a strong foundation for the compound's development in the course of subsequent clinical phases in autoimmune diseases, including disorders for which proven effective therapy exists.