The development of the preclinical and clinical innovation of the TrinB agonist in the therapy of nervous system diseases (Q78893): Difference between revisions
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(Created claim: summary (P836): Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).Depression is the most common central nervous health condition.The use of currently available antidepressants is associated with certain limitations, since the...) |
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Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).Depression is the most common central nervous health condition.The use of currently available antidepressants is associated with certain limitations, since therapeutic effects can only be observed after several weeks of regular medication.In addition, the current treatments involve restrictions in the form of:risk of spill-over effects and drug resistance.Therefore, there is still a need to develop innovative and secure therapies.The TrkB agonist receptor agonist mimics biological agent functions (BDNF), which, given the current state of the art, is key to obtain a therapeutic effect.The applicant is planning a synthesis of the new, ‘TrkB receptor agonist’, which will be selected from the library of the compounds by studying the effects of receptor, physicochemical properties, in vitro activity and Admet parameters.An in vivo study, which confirms the antidepressant action and the cognitive agonist chosen, will be carried out in a rodent and using dedicated animal depression models.In order to confirm the safety of the link, non-clinical pharmacological and toxicological tests will be carried out in accordance with the guidelines of the European Medicines Agency.Confirmation of the security of the chosen link, together with the determination of the appropriate formulation and dosage of the drug, will allow the trial phase to start.Phase I of the clinical trial will make it possible to assess the safety of the TrkB agonist and to specify the recommended dose of medicine for Phase IIa.As the final proof of a candidate’s activity in medicine, Phase IIa testing will be carried out on patients with depressive disorders (English) | |||
| Property / summary: Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).Depression is the most common central nervous health condition.The use of currently available antidepressants is associated with certain limitations, since therapeutic effects can only be observed after several weeks of regular medication.In addition, the current treatments involve restrictions in the form of:risk of spill-over effects and drug resistance.Therefore, there is still a need to develop innovative and secure therapies.The TrkB agonist receptor agonist mimics biological agent functions (BDNF), which, given the current state of the art, is key to obtain a therapeutic effect.The applicant is planning a synthesis of the new, ‘TrkB receptor agonist’, which will be selected from the library of the compounds by studying the effects of receptor, physicochemical properties, in vitro activity and Admet parameters.An in vivo study, which confirms the antidepressant action and the cognitive agonist chosen, will be carried out in a rodent and using dedicated animal depression models.In order to confirm the safety of the link, non-clinical pharmacological and toxicological tests will be carried out in accordance with the guidelines of the European Medicines Agency.Confirmation of the security of the chosen link, together with the determination of the appropriate formulation and dosage of the drug, will allow the trial phase to start.Phase I of the clinical trial will make it possible to assess the safety of the TrkB agonist and to specify the recommended dose of medicine for Phase IIa.As the final proof of a candidate’s activity in medicine, Phase IIa testing will be carried out on patients with depressive disorders (English) / rank | |||
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Revision as of 08:53, 4 March 2020
Project in Poland financed by DG Regio
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | The development of the preclinical and clinical innovation of the TrinB agonist in the therapy of nervous system diseases |
Project in Poland financed by DG Regio |
Statements
22,878,140.0 zloty
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34,442,836.0 zloty
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66.42 percent
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1 October 2017
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30 September 2022
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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). Depresja to najczęściej występujące schorzenie ośrodkowego układu nerwowego. Stosowanie obecnie dostępnych terapii przeciwdepresyjnych wiąże się z pewnymi ograniczeniami, ponieważ efekty terapeutyczne obserwuje się dopiero po kilku tygodniach regularnego przyjmowania leków. Ponadto, obecne terapie wiążą się z ograniczeniami w postaci: ryzyka skutków ubocznych oraz lekooporności. W związku z tym, wciąż istnieje potrzeba rozwoju innowacyjnych i bezpiecznych terapii. Małocząsteczkowy agonista receptora TrkB naśladuje biologiczne funkcje czynnika neurotroficznego (BDNF), który, biorąc pod uwagę obecny stan wiedzy, jest kluczowy dla uzyskania efektu terapeutycznego. Wnioskodawca planuje syntezę nowego, selektywnego agonisty receptora TrkB, który zostanie wybrany spośród biblioteki związków poprzez badanie oddziaływań z receptorem, właściwości fizykochemicznych, aktywności in vitro oraz parametrów ADMET. Badania in vivo, potwierdzające działanie przeciwdepresyjne oraz prokognitywne wybranego agonisty, zostaną przeprowadzone na gryzoniach oraz z wykorzystaniem dedykowanych zwierzęcych modeli depresji. W celu potwierdzenia bezpieczeństwa związku, przeprowadzone zostaną przedkliniczne badania farmakologiczne i toksykologiczne, zgodnie z wytycznymi Europejskiej Agencji Leków. Potwierdzenie bezpieczeństwa wybranego związku, wspólnie z ustaleniem odpowiedniej formulacji oraz dawkowania leku pozwoli na rozpoczęcie etapu badania klinicznego. Faza I badania klinicznego pozwoli ocenić bezpieczeństwo agonisty TrkB oraz określić rekomendowaną dawkę leku dla fazy IIa. Jako końcowy dowód aktywności kandydata na lek, badanie fazy IIa zostanie przeprowadzone na pacjentach z zaburzeniami depresyjnymi (Polish)
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Reference_reference_programme_aids:SA.41471 (2015/X) _public:Article 25 of Commission Regulation (EC) No 651/2014 of 17 June 2014 declaring certain categories of aid compatible with the internal market in the application of Article 107 and 108 of the Treaty (OJ(OJ LEU L 187/1, 26.06.2014).Depression is the most common central nervous health condition.The use of currently available antidepressants is associated with certain limitations, since therapeutic effects can only be observed after several weeks of regular medication.In addition, the current treatments involve restrictions in the form of:risk of spill-over effects and drug resistance.Therefore, there is still a need to develop innovative and secure therapies.The TrkB agonist receptor agonist mimics biological agent functions (BDNF), which, given the current state of the art, is key to obtain a therapeutic effect.The applicant is planning a synthesis of the new, ‘TrkB receptor agonist’, which will be selected from the library of the compounds by studying the effects of receptor, physicochemical properties, in vitro activity and Admet parameters.An in vivo study, which confirms the antidepressant action and the cognitive agonist chosen, will be carried out in a rodent and using dedicated animal depression models.In order to confirm the safety of the link, non-clinical pharmacological and toxicological tests will be carried out in accordance with the guidelines of the European Medicines Agency.Confirmation of the security of the chosen link, together with the determination of the appropriate formulation and dosage of the drug, will allow the trial phase to start.Phase I of the clinical trial will make it possible to assess the safety of the TrkB agonist and to specify the recommended dose of medicine for Phase IIa.As the final proof of a candidate’s activity in medicine, Phase IIa testing will be carried out on patients with depressive disorders (English)
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Identifiers
POIR.01.02.00-00-0020/17
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