Date prepared: November 19, 2021, time: 9:29 p.m.<\/p>\n\n\n\n
Abbreviated name of the issuer: CELON PHARMA S.A.<\/p>\n\n\n\n
Subject:\u00a0Submission of an application for consent to commence a Phase II\u00a0clinical trial of a drug based on a innovative JAK\/ROCK inhibitor \u2013 CPL 409116 \u2013 in the treatment of rheumatoid arthritis (RA)<\/p>\n\n\n\n
Legal basis: Article 17 of the Market Abuse Regulation (MAR) \u2013 confidential information.<\/p>\n\n\n\n
The Management Board of Celon Pharma S.A. (the \u201cCompany\u201d) hereby informs that on 19 November 2021 it submitted an application to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products for consent to commence a phase II clinical trial of this compound.<\/p>\n\n\n\n
The purpose of this trial is to evaluate the efficacy, pharmacokinetics and safety of CPL409116 administered at multiple doses in combination with methotrexate compared to placebo in patients with active rheumatoid arthritis and an unsatisfactory therapeutic response to methotrexate.<\/p>\n\n\n\n
CPL 409116 is a dual JAK and ROCK kinase inhibitor that the Company is developing in autoimmune indications, including in patients with rheumatoid arthritis with coexisting interstitial lung disease (RA-ILD). RA-ILD affects 7-15% of patients with rheumatoid arthritis. On average, patients suffering from this disease have a short, 6-8 year survival from diagnosis and so far no treatment for this indication has been approved worldwide.<\/p>\n\n\n\n
It is a multi-centre double-blind trial conducted on approx. 100 patients. It will last approx. 10 months. <\/p>\n\n\n\n