Implementation of CELON PHARMA S.A. and development of CPL409116, an innovative inhibitor of JAK and ROCK kinases as an oral drug in the treatment of idiopathic pulmonary fibrosis. (Q2686465): Difference between revisions
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Implementation of CELON PHARMA S.A. and development of CPL409116, an innovative inhibitor of JAK and ROCK kinases as an oral drug in the treatment of idiopathic pulmonary fibrosis. | |||||||||||||||
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Reference_Aid_programme: SA.41471(2015/X) Purpose_public_aid: Article: 25 of Commission Regulation (EU) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty Urz. EU L 187/1 of 26.06.2014). Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal and severe disease. It causes scarring of the lungs, disrupting breathing processes and consequently leads to death, and the average survival of the patient is 2-5 years after diagnosis. Currently, there are 2 medicines on the market that slow down pulmonary functionalities, but their use poses a significant risk of toxicity. As a result, approx. a year. 30 % of patients discontinue treatment without therapeutic options. The compound CPL409116, a small molecular inhibitor of kinases JAK and ROCK, is an innovative candidate for the treatment of IPF. In the course of this disease, progressive fibrosis changes in the pulmonary tissue are accompanied by developing inflammation. CPL409116, a dual inhibitor of JAK and ROCK kinases, can simultaneously block the development of inflammatory and fibrous processes. This molecule is currently being developed in the project POIR.01.01.01-00-0382/16, which developed the synthesis path and carried out preclinical studies confirming the effectiveness of the compound in blocking inflammatory processes. In addition, in toxicological studies CPL409116 was characterised by a favourable safety profile. In vivo pilot studies, in the bleomycin-induced pulmonary fibrosis model, confirmed the effectiveness of the candidate. As part of the project submitted for assessment, further studies of the therapeutic efficacy of the compound CPL409116 as a drug on the IPF were planned. The ultimate objective of this project is to evaluate the candidate for the drug, as part of the Phase II clinical trial, in the indication of idiopathic pulmonary fibrosis. The project is divided into four stages: three industrial and one development. As part of the Applicant’s project (English) | |||||||||||||||
| Property / summary: Reference_Aid_programme: SA.41471(2015/X) Purpose_public_aid: Article: 25 of Commission Regulation (EU) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty Urz. EU L 187/1 of 26.06.2014). Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal and severe disease. It causes scarring of the lungs, disrupting breathing processes and consequently leads to death, and the average survival of the patient is 2-5 years after diagnosis. Currently, there are 2 medicines on the market that slow down pulmonary functionalities, but their use poses a significant risk of toxicity. As a result, approx. a year. 30 % of patients discontinue treatment without therapeutic options. The compound CPL409116, a small molecular inhibitor of kinases JAK and ROCK, is an innovative candidate for the treatment of IPF. In the course of this disease, progressive fibrosis changes in the pulmonary tissue are accompanied by developing inflammation. CPL409116, a dual inhibitor of JAK and ROCK kinases, can simultaneously block the development of inflammatory and fibrous processes. This molecule is currently being developed in the project POIR.01.01.01-00-0382/16, which developed the synthesis path and carried out preclinical studies confirming the effectiveness of the compound in blocking inflammatory processes. In addition, in toxicological studies CPL409116 was characterised by a favourable safety profile. In vivo pilot studies, in the bleomycin-induced pulmonary fibrosis model, confirmed the effectiveness of the candidate. As part of the project submitted for assessment, further studies of the therapeutic efficacy of the compound CPL409116 as a drug on the IPF were planned. The ultimate objective of this project is to evaluate the candidate for the drug, as part of the Phase II clinical trial, in the indication of idiopathic pulmonary fibrosis. The project is divided into four stages: three industrial and one development. As part of the Applicant’s project (English) / rank | |||||||||||||||
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| Property / summary: Reference_Aid_programme: SA.41471(2015/X) Purpose_public_aid: Article: 25 of Commission Regulation (EU) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty Urz. EU L 187/1 of 26.06.2014). Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal and severe disease. It causes scarring of the lungs, disrupting breathing processes and consequently leads to death, and the average survival of the patient is 2-5 years after diagnosis. Currently, there are 2 medicines on the market that slow down pulmonary functionalities, but their use poses a significant risk of toxicity. As a result, approx. a year. 30 % of patients discontinue treatment without therapeutic options. The compound CPL409116, a small molecular inhibitor of kinases JAK and ROCK, is an innovative candidate for the treatment of IPF. In the course of this disease, progressive fibrosis changes in the pulmonary tissue are accompanied by developing inflammation. CPL409116, a dual inhibitor of JAK and ROCK kinases, can simultaneously block the development of inflammatory and fibrous processes. This molecule is currently being developed in the project POIR.01.01.01-00-0382/16, which developed the synthesis path and carried out preclinical studies confirming the effectiveness of the compound in blocking inflammatory processes. In addition, in toxicological studies CPL409116 was characterised by a favourable safety profile. In vivo pilot studies, in the bleomycin-induced pulmonary fibrosis model, confirmed the effectiveness of the candidate. As part of the project submitted for assessment, further studies of the therapeutic efficacy of the compound CPL409116 as a drug on the IPF were planned. The ultimate objective of this project is to evaluate the candidate for the drug, as part of the Phase II clinical trial, in the indication of idiopathic pulmonary fibrosis. The project is divided into four stages: three industrial and one development. As part of the Applicant’s project (English) / qualifier | |||||||||||||||
point in time: 3 December 2021
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Revision as of 11:19, 3 December 2021
Project Q2686465 in Poland
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Implementation of CELON PHARMA S.A. and development of CPL409116, an innovative inhibitor of JAK and ROCK kinases as an oral drug in the treatment of idiopathic pulmonary fibrosis. |
Project Q2686465 in Poland |
Statements
18,769,450.25 zloty
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36,407,885.0 zloty
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51.55 percent
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1 September 2020
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30 September 2023
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CELON PHARMA S.A.
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52°20'7.8"N, 20°53'42.0"E
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Numer_referencyjny_programu_pomocowego: SA.41471(2015/X) Przeznaczenie_pomocy_publicznej: art: 25 rozporządzenia KE nr 651/2014 z dnia 17 czerwca 2014 r. uznające niektóre rodzaje pomocy za zgodne z rynkiem wewnętrznym w stosowaniu art. 107 i 108 Traktatu (Dz. Urz. UE L 187/1 z 26.06.2014). Idiopatyczne zwłóknienie płuc (IPF) to postępująca, śmiertelna choroba o ciężkim przebiegu. Wywołuje ona bliznowacenie płuc, zaburzając procesy oddychania i w konsekwencji prowadzi do śmierci, a średnie przeżycie pacjenta wynosi 2-5 lat od diagnozy. Obecnie na rynku dostępne są 2 leki, które spowalniają spadek funkcjonalności płuc, jednak ich stosowanie jest obarczone znacznym ryzykiem toksyczności. W efekcie rocznie ok. 30% chorych przerywa leczenie, pozostając bez opcji terapeutycznych. Związek CPL409116, małocząsteczkowy inhibitor kinaz JAK i ROCK jest innowacyjnym kandydatem na lek w leczeniu IPF. W przebiegu tej choroby postępującym zmianom zwłóknieniowym tkanki płucnej towarzyszy rozwijający się stan zapalny. CPL409116, dualny inhibitor kinaz JAK i ROCK, może równocześnie blokować rozwój procesów zapalnych i zwłóknieniowych. Cząsteczka ta jest obecnie rozwijana w projekcie POIR.01.01.01-00-0382/16, w ramach którego opracowano ścieżkę syntezy oraz przeprowadzono badania przedkliniczne potwierdzające efektywność związku w blokowaniu procesów zapalnych. Dodatkowo, w badaniach toksykologicznych CPL409116 charakteryzował się korzystnym profilem bezpieczeństwa. Pilotażowe badania in vivo, w modelu zwłóknienia płuc indukowanego bleomycyną, potwierdziły efektywność omawianego kandydata. W ramach przedkładanego do oceny projektu, zaplanowano dalsze badania efektywności terapeutycznej związku CPL409116 jako leku na IPF. Ostatecznym celem tego projektu, jest ewaluacja kandydata na lek, w ramach badania klinicznego fazy II, we wskazaniu idiopatycznego zwłóknienia płuc. Projekt podzielono na cztery etapy: trzy przemysłowe oraz jeden rozwojowy. W ramach projektu Wnioskodawca (Polish)
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Reference_Aid_programme: SA.41471(2015/X) Purpose_public_aid: Article: 25 of Commission Regulation (EU) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Articles 107 and 108 of the Treaty Urz. EU L 187/1 of 26.06.2014). Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal and severe disease. It causes scarring of the lungs, disrupting breathing processes and consequently leads to death, and the average survival of the patient is 2-5 years after diagnosis. Currently, there are 2 medicines on the market that slow down pulmonary functionalities, but their use poses a significant risk of toxicity. As a result, approx. a year. 30 % of patients discontinue treatment without therapeutic options. The compound CPL409116, a small molecular inhibitor of kinases JAK and ROCK, is an innovative candidate for the treatment of IPF. In the course of this disease, progressive fibrosis changes in the pulmonary tissue are accompanied by developing inflammation. CPL409116, a dual inhibitor of JAK and ROCK kinases, can simultaneously block the development of inflammatory and fibrous processes. This molecule is currently being developed in the project POIR.01.01.01-00-0382/16, which developed the synthesis path and carried out preclinical studies confirming the effectiveness of the compound in blocking inflammatory processes. In addition, in toxicological studies CPL409116 was characterised by a favourable safety profile. In vivo pilot studies, in the bleomycin-induced pulmonary fibrosis model, confirmed the effectiveness of the candidate. As part of the project submitted for assessment, further studies of the therapeutic efficacy of the compound CPL409116 as a drug on the IPF were planned. The ultimate objective of this project is to evaluate the candidate for the drug, as part of the Phase II clinical trial, in the indication of idiopathic pulmonary fibrosis. The project is divided into four stages: three industrial and one development. As part of the Applicant’s project (English)
3 December 2021
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Identifiers
POIR.01.01.01-00-0453/20
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