Clinical evaluation of Phase II and verification of predictive response factors for CPL500036 — an innovative PDE10 inhibitor in the treatment of L-DOPA-induced dyskinesia in Parkinson’s disease (Q2686508): Difference between revisions
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(Changed label, description and/or aliases in en, pl, and other parts: Moving texts from en to pl) |
(Changed label, description and/or aliases in en, and other parts: Adding English translations) |
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Clinical evaluation of Phase II and verification of predictive response factors for CPL500036 — an innovative PDE10 inhibitor in the treatment of L-DOPA-induced dyskinesia in Parkinson’s disease | |||||||||||||||
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The project aims at the clinical evaluation of Phase II and the verification of the predictive factors for first-in-class responses, an innovative small-molecular PDE10A inhibitor (CPL500036) as a candidate for the treatment of dyskinesia occurring after long-term administration of L-DOPA in Parkinson’s disease (PD) together with preclinical studies necessary for pre-phase clinical trials. Dyskinesia occurring within Parkinson’s disease and caused by L-DOPA administration is an unmet need for patients and doctors, as the available therapies have limited effectiveness and a number of side effects preventing their extensive use. CPL500036, the subject of research in this project, successfully underwent phase I clinical trials, where its safety, tolerance and bioavailability profile was confirmed. Based on literature reports in which PDE10A inhibitors may exhibit anti-dyskinetic effects, the applicant has performed behavioural experiments in rat PD models, demonstrating that CPL500036 effectively reduces L-DOPA-induced dyskinesia. The project will be implemented over a period of 43 months in 2 stages. Development will include the preparation and conduct of a Phase II clinical trial of the product containing CPL500036 in which the product will be administered to patients suffering from L-DOPA-induced dyskinesia for the first time. 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). (English) | |||||||||||||||
| Property / summary: The project aims at the clinical evaluation of Phase II and the verification of the predictive factors for first-in-class responses, an innovative small-molecular PDE10A inhibitor (CPL500036) as a candidate for the treatment of dyskinesia occurring after long-term administration of L-DOPA in Parkinson’s disease (PD) together with preclinical studies necessary for pre-phase clinical trials. Dyskinesia occurring within Parkinson’s disease and caused by L-DOPA administration is an unmet need for patients and doctors, as the available therapies have limited effectiveness and a number of side effects preventing their extensive use. CPL500036, the subject of research in this project, successfully underwent phase I clinical trials, where its safety, tolerance and bioavailability profile was confirmed. Based on literature reports in which PDE10A inhibitors may exhibit anti-dyskinetic effects, the applicant has performed behavioural experiments in rat PD models, demonstrating that CPL500036 effectively reduces L-DOPA-induced dyskinesia. The project will be implemented over a period of 43 months in 2 stages. Development will include the preparation and conduct of a Phase II clinical trial of the product containing CPL500036 in which the product will be administered to patients suffering from L-DOPA-induced dyskinesia for the first time. 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). (English) / rank | |||||||||||||||
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| Property / summary: The project aims at the clinical evaluation of Phase II and the verification of the predictive factors for first-in-class responses, an innovative small-molecular PDE10A inhibitor (CPL500036) as a candidate for the treatment of dyskinesia occurring after long-term administration of L-DOPA in Parkinson’s disease (PD) together with preclinical studies necessary for pre-phase clinical trials. Dyskinesia occurring within Parkinson’s disease and caused by L-DOPA administration is an unmet need for patients and doctors, as the available therapies have limited effectiveness and a number of side effects preventing their extensive use. CPL500036, the subject of research in this project, successfully underwent phase I clinical trials, where its safety, tolerance and bioavailability profile was confirmed. Based on literature reports in which PDE10A inhibitors may exhibit anti-dyskinetic effects, the applicant has performed behavioural experiments in rat PD models, demonstrating that CPL500036 effectively reduces L-DOPA-induced dyskinesia. The project will be implemented over a period of 43 months in 2 stages. Development will include the preparation and conduct of a Phase II clinical trial of the product containing CPL500036 in which the product will be administered to patients suffering from L-DOPA-induced dyskinesia for the first time. 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). (English) / qualifier | |||||||||||||||
point in time: 3 December 2021
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Revision as of 11:19, 3 December 2021
Project Q2686508 in Poland
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | Clinical evaluation of Phase II and verification of predictive response factors for CPL500036 — an innovative PDE10 inhibitor in the treatment of L-DOPA-induced dyskinesia in Parkinson’s disease |
Project Q2686508 in Poland |
Statements
8,124,649.16 zloty
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17,095,154.47 zloty
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47.53 percent
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2 June 2020
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29 December 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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Projekt ma na celu ewaluację kliniczną II fazy i weryfikację czynników predykcyjnych odpowiedzi dla pierwszego w klasie (first-in-class), innowacyjnego, małocząsteczkowego inhibitora PDE10A (CPL500036) jako kandydata na lek w terapii dyskinez występujących po długotrwałym podawaniu L-DOPA w chorobie Parkinsona (PD) wraz z badaniami przedklinicznymi niezbędnymi do wykonania przed III fazą badań klinicznych. Dyskinezy występujące w obrębie choroby Parkinsona i spowodowane podawaniem L-DOPA stanowią niezaspokojoną potrzebę ze strony pacjentów i lekarzy, ponieważ dostępne terapie posiadają ograniczoną efektywność i szereg efektów ubocznych uniemożliwiających ich szerokie stosowanie. CPL500036, będący obiektem badań w niniejszym projekcie, z powodzeniem przeszedł I fazę badań klinicznych, gdzie potwierdzony został jego profil bezpieczeństwa, tolerancji i biodostępności. Na podstawie doniesień literaturowych, w których inhibitory PDE10A mogą wykazywać działanie przeciwdyskinetyczne, wnioskodawca wykonał doświadczenia behawioralne w szczurzym modelu PD, wykazując że CPL500036 skutecznie osłabia dyskinezy wywołane L-DOPA. Projekt będzie realizowany przez okres 43 miesięcy w 2 etapach. Prace rozwojowe obejmą przygotowanie i przeprowadzenie badania klinicznego II fazy produktu zawierającego substancję CPL500036, w którym produkt zostanie podany pacjentom cierpiącym z powodu dyskinez indukowanych L-DOPA po raz pierwszy. 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). (Polish)
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The project aims at the clinical evaluation of Phase II and the verification of the predictive factors for first-in-class responses, an innovative small-molecular PDE10A inhibitor (CPL500036) as a candidate for the treatment of dyskinesia occurring after long-term administration of L-DOPA in Parkinson’s disease (PD) together with preclinical studies necessary for pre-phase clinical trials. Dyskinesia occurring within Parkinson’s disease and caused by L-DOPA administration is an unmet need for patients and doctors, as the available therapies have limited effectiveness and a number of side effects preventing their extensive use. CPL500036, the subject of research in this project, successfully underwent phase I clinical trials, where its safety, tolerance and bioavailability profile was confirmed. Based on literature reports in which PDE10A inhibitors may exhibit anti-dyskinetic effects, the applicant has performed behavioural experiments in rat PD models, demonstrating that CPL500036 effectively reduces L-DOPA-induced dyskinesia. The project will be implemented over a period of 43 months in 2 stages. Development will include the preparation and conduct of a Phase II clinical trial of the product containing CPL500036 in which the product will be administered to patients suffering from L-DOPA-induced dyskinesia for the first time. 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). (English)
3 December 2021
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Identifiers
POIR.01.01.01-00-0617/20
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