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TT4CL

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Clinical development of oral oleylphosphocholine as a new drug for the treatment...

Clinical development of oral oleylphosphocholine as a new drug for the treatment of Old World Cutaneous Leishmaniasis Cutaneous leishmaniasis (CL) is a poverty related, neglected tropical disease, which is without an effective and cheap systemic treatment. The aim of TT4CL is to develop a new orally available drug for treatment of CL aimed toward... ver más

31/07/2024

ST GEORGES HOSPITA...

4M€

Presupuesto del proyecto: 4M€

Líder del proyecto

ST GEORGES HOSPITAL MEDICAL SCHOOL No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 9 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2024-07-31

SC1-BHC-15-2018: New anti-infective agents for preve...

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Cerrada hace 6 años

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

9 Participantes

ST GEORGES HOSPITAL MEDICAL...

1.18M€ | Lider

Avivia Beheer BV

591.00K€ | Participante

DACHGENOSSENSCHAFT WOHNEN TU...

N.D. | Participante

Oblita

367.55K€ | Participante

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Duración del proyecto: 63 meses Fecha Inicio: 2019-04-30
Fecha Fin: 2024-07-31

Líder del proyecto

ST GEORGES HOSPITAL MEDICAL SCHOOL No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 4M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto Cutaneous leishmaniasis (CL) is a poverty related, neglected tropical disease, which is without an effective and cheap systemic treatment. The aim of TT4CL is to develop a new orally available drug for treatment of CL aimed towards registration with stringent regulatory authorities. Oleylphosphocholine (OlPC), regarded as a new drug by the FDA, is structurally related to the anti-leishmanial miltefosine. It is being developed as an immediate-release tablet for the treatment of CL and, currently, is the only systemically delivered drug specifically being developed for this indication. OlPC is active in vitro and in vivo against different CL-causing Leishmania parasite species and shows curative advantage over miltefosine in rodent models of leishmaniasis. The primary objective of this study is to complete the pre-clinical package that is essential for the subsequent clinical development of OlPC. The project will aim to optimize the synthesis and formulation of OlPC, including stability testing that is appropriate for tropical climates. It will include in vitro drug sensitivity analyses in parasites causing CL (Leishmania tropica and L. major) in the Islamic Republic of Iran, with our endemic-country partner. Comparative studies in animal models with existing anti-leishmanial compounds will establish efficacy advantages and determine pharmacokinetic-pharmacodynamic relationships for OlPC. Phase 1 studies will confirm tolerability and pharmacokinetics of single doses and multiple dosing regimens. Results will be used to guide decisions by future partners on the clinical development of OlPC. This proposal directly addresses the priorities highlighted in this H2020 call. To our knowledge, we are the only consortium that is implementing this type of approach, and there is no other interest in the pharmaceutical sector to carry out a development programme for the oral treatment of CL.

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