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Clinical development of oral oleylphosphocholine as a new drug for the treatment of Old World Cutaneous Leishmaniasis

Clinical development of oral oleylphosphocholine as a new drug for the treatment of Old World Cutaneous Leishmaniasis

Objective

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.

Coordinator

ST GEORGE'S HOSPITAL MEDICAL SCHOOL

Address

Cranmer Terrace
Sw17 0re London

United Kingdom

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 1 273 863,89

Participants (5)

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OBLITA THERAPEUTICS

Belgium

EU Contribution

€ 367 550

LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER

United Kingdom

EU Contribution

€ 569 196,12

AVIVIA BEHEER BV

Netherlands

EU Contribution

€ 591 000

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Germany

EU Contribution

€ 580 150

TEHRAN UNIVERSITY OF MEDICAL SCIENCES

Iran

EU Contribution

€ 371 375,55

Project information

Grant agreement ID: 815622

Status

Ongoing project

  • Start date

    1 May 2019

  • End date

    30 April 2023

Funded under:

H2020-EU.3.1.3.

Coordinated by:

ST GEORGE'S HOSPITAL MEDICAL SCHOOL

United Kingdom