Sustained efforts to develop safer, simpler, more effective treatments for the neglected tropical disease are urgently needed
DNDi is pleased to announce the renewed commitment of the Global Health Innovative Technology Fund (GHIT Fund) to DNDi’s development of CpG-D35 as a novel treatment for cutaneous leishmaniasis.
Cutaneous leishmaniasis is a neglected tropical disease transmitted through the bite of sandflies that is estimated to infect up to one million people every year. Communities affected by poverty, malnutrition, displacement, and poor housing conditions are most at risk. Although cutaneous leishmaniasis is not life-threatening, its impact can be devastating: the disease causes skin lesions that form on the face or other exposed areas, leaving disfiguring, life-long scars that bring severe social stigma, particularly for women and children.
Current treatments for cutaneous leishmaniasis are costly, and often require weeks of painful injections of toxic drugs called antimonials. Despite their severe side effects, the drugs have been used to treat the disease for nearly 70 years.
‘Cutaneous leishmaniasis takes a terrible toll on communities already impacted by hardship and trauma, particularly people displaced by conflict and war,’ said Dr Byron Arana, Head of the Cutaneous Leishmaniasis Programme at DNDi. ‘DNDi is grateful for GHIT Fund’s continued commitment to the development of CpG-D35, which we hope can help to address patients’ serious and longstanding unmet medical needs.’
As an innovative ‘immunomodulator’, CpG-D35’s potential rests in its unique mode of action compared to standard drug therapies. By stimulating the immune system’s innate response to fight the parasitic infection that causes cutaneous leishmaniasis, CpG-D35 has the potential to dramatically improve treatment outcomes by boosting the effectiveness of existing or future drugs. Data generated to date support the hypothesis that CpG-D35 alone or in combination with drug therapy will reduce infection and accelerate the healing of cutaneous leishmaniasis lesions.
The new funding of JPY 692 million (5.5 million EUR) will enable DNDi to conduct a Phase I clinical trial with its partner the University of Tokyo to assess the safety and tolerability of CpG-D35 in healthy adult volunteers. It will also allow DNDi to refine the manufacturing process for the compound, together with Ajinomoto Bio-Pharma Services, a leading Japanese provider of biopharmaceutical contract development and manufacturing services.
These efforts follow the successful pre-clinical development of CpG-D35 – including in vivo efficacy and pre-clinical toxicology studies, also made possible with GHIT Fund support.
About cutaneous leishmaniasis
Transmitted through the bites of infected female phlebotomine sandflies, cutaneous leishmaniasis is a parasitic disease that can be caused by more than 15 species of the protozoan Leishmania parasite. Cutaneous leishmaniasis first appears as a small bump on the skin, which progressively becomes an ulcer. In 2018, over 85% of new cutaneous leishmaniasis cases occurred in 10 countries: Afghanistan, Algeria, Bolivia, Brazil, Colombia, Iran, Iraq, Pakistan, Syria, and Tunisia. Epidemics of cutaneous leishmaniasis are often linked to conflict and displacement, affecting refugees and migrants with inadequate access to housing, healthcare, nutrition, and hygiene services.
About GHIT Fund
The GHIT Fund is a Japan-based international public-private partnership fund (PPP) between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, the Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests and manages an R&D portfolio of development partnerships aimed at neglected diseases, such as malaria, tuberculosis and neglected tropical diseases that afflict the world’s vulnerable and underserved populations. The GHIT Fund mobilizes the Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases, in collaboration with global partners. To know more about GHIT Fund, please visit www.ghitfund.org/
The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit, patient-oriented research and development organization working to deliver safe, effective, and accessible treatments for millions of people living in vulnerable conditions and affected by neglected diseases, notably Chagas disease, leishmaniasis, sleeping sickness, paediatric HIV, hepatitis C, river blindness, and mycetoma. DNDi is also mobilizing its networks to accelerate urgently needed research on COVID-19 in resource-limited settings.
About Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including Corynex® protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client’s needs. Learn more: www.AjiBio-Pharma.com
Media contact DNDi
Phone (+41) 79 431 6216
Photo credit: Vinicius Berger-DNDi