TOKYO, Nov. 7, 2024 /PRNewswire/ — The Global Health Innovative Technology (GHIT) Fund announced today a total investment of approximately JPY 578 million (USD 4.0 million1) in four projects for the development of new diagnostics and drugs for neglected tropical diseases (NTDs) and malaria. 2
GHIT’s First Investment of Approximately JPY 280 Million (USD 2.0 Million1) in the Development of a Rapid Diagnostic Test for Trachoma
Trachoma, caused by infection of the conjunctiva (upper inner eyelid) by the bacterium Chlamydia trachomatis, is a neglected tropical disease (NTD) prevalent primarily in areas with poor sanitation. As the disease progresses, it eventually leads to blindness. Trachoma remains a public health issue in 39 countries, with over 103 million people at risk of infection. The disease spreads through contact with hands, clothing, bedding, and other surfaces, as well as through flies that come into contact with eye and nose discharge from infected individuals. 3 The World Health Organization (WHO) has set a goal to eliminate trachoma as a public health problem by 2030, and rapid and accurate diagnosis is critical in achieving this target.
In order to overcome this situation, the GHIT Fund has decided to invest approximately JPY 280 million (USD 2.0 million1) in a project led by US-based non-profit organization Drugs & Diagnostics for Tropical Diseases (DDTD), in collaboration with Medical & Biological Laboratories, Co. Ltd. (MBL) in Japan, The Carter Center (TCC, USA), and Big Eye Diagnostics, Inc. (BEDx, USA), with active support from the Centers for Disease Control and Prevention (CDC), to develop a Rapid Diagnostic Test (RDT) kit for trachoma. This is the first time for the GHIT Fund to support product development targeting trachoma. The project is expected to enable early detection and appropriate treatment for over 100 million people at risk of blindness and vision loss, significantly advancing the global goal of eliminating trachoma.
In addition, the GHIT Fund has decided to invest in three product development projects targeting malaria and Chagas disease. The investments include approximately JPY 150 million (USD 1.0 million1) in an antimalarial drug discovery project involving a partnership of Nagasaki University, The University of Tokyo, Shionogi & Co., Ltd., and Medicines for Malaria Venture (MMV); approximately JPY 70 million (USD 0.49 million1) in a rapid diagnostic test development project for Chagas disease involving Nagasaki University, Tulane University, and the Barcelona Institute for Global Health (ISGlobal); and approximately JPY 70 million (USD 0.48 million1) in a malaria drug discovery project involving The University of Tokyo, MMV, the University of Oxford, and the University of Dundee.
Please refer to Appendix 1 for a detailed description of each project and its development stage.
As of September 30, 2024, the GHIT Fund has invested in 33 projects, including 11 discovery projects, 14 preclinical projects, and 8 clinical trials. 4 The total amount of investments since 2013 is JPY 33.8 billion (USD 236 million) (Appendix 2).
1 USD1 = JPY142.82, the approximate exchange rate on September 30, 2024.
2 These awarded projects were selected and approved as new investments from among proposals to RFP2023-002 and RFP2024-001 for the Product Development Platform, which was open for applications from November 2023 to July 2024.
3 WHO: https://www.who.int/news-room/fact-sheets/detail/trachoma
4 This number includes projects in the registration phase.
The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world’s vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases.
https://www.ghitfund.org/en
Appendix 1. Project Details
G2024-108
Project Title
A First-in-class, Fully TPP-compliant Rapid Diagnostic Test for Trachoma Surveillance: Delivering the Missing Piece in WHO’s Worldwide Trachoma Elimination Efforts
Collaboration
Partners
1. Drugs & Diagnostics for Tropical Diseases (DDTD) (USA)
2. Medical & Biological Laboratories, Co. Ltd. (MBL) (Japan)
3. The Carter Center (TCC) (USA)
4. Big Eye Diagnostics, Inc. (BEDx) (USA)
Self-funded Research Partner: Centers for Disease Control and Prevention (CDC) (USA)
Disease
Trachoma
Intervention
Diagnostics
Stage
Product Development
Awarded Amount
JPY 288,958,766 (USD 2.0 million)
Status
New project
Summary
[Project objective]
The overarching objective of this project is to deliver a rapid diagnostic test (RDT) to detect exposure to Chlamydia trachomatis, the pathogen causing trachoma. Our test will meet all key criteria of WHO’s Target Product Profile (TPP) for trachoma surveillance and will be delivered in both a dipstick and a cassette format.
[Project design]
The project team will pursue the following 6 specific objectives:
-Objective 1 (MBL): One key factor to ensure reproducible product quality is to have a constant, reliable source of the biological components of the test. MBL will be in charge of this key task and produce the C. trachomatis antigen.
-Objective 2 (DDTD): A functional prototype RDT has already been generated and validated by the CDC, and subsequently reproduced and partially optimized at DDTD. This test will now be fully optimized until it satisfies all key TPP criteria.
-Objective 3 (CDC): Once an optimized candidate test has been nominated by DDTD, CDC will provide an independent validation of TPP compliance in terms of sensitivity and specificity.
-Objective 4 (TCC): TCC will work with the Trachoma Monitoring Laboratory to further validate the RDT for diagnostic performance and user-friendliness (feasibility) in one of the intended use cases.
-Objective 5 (DDTD, BEDx): DDTD will develop a robust, ISO13485-compliant large-scale manufacturing process commensurate with the expected demand forecast of up to 700’000 tests/year and the ideal target pricing of
