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Newsletter No ▲ 7 ▲ Newsletter No. ▲ Chagas Disease Clinical Research Platform he Chagas Disease Clinical Platform promotes annual meetings, patient associations. Research Platform was training, standardization of protocols, Recent advances in knowledge paired created in 2009, the centennial regulatory aspects, and integration of T with an increasing number of research anniversary of the discovery of the disease. ethical principles. The Platform provides investigations and initiatives for Its main objective is to provide support a forum for technical discussions Chagas disease provide renewed with overcoming challenges in research and and exchange of information about optimism and underline the importance development (R&D) for Chagas disease Chagas disease, while supporting of open collaboration and fluid through a flexible network focused efficient use of resources by avoiding exchange of information. Striving for on meeting health needs and duplication of efforts. cooperation among R&D initiatives, facilitating diagnosis and treatment of Currently, the network comprises the Chagas Platform continues to T. cruzi infection. more than 370 members from 23 facilitate clinical research, promote In this manner, the Platform continues endemic and nonendemic countries. professional development, and to pursue mechanisms and synergies to Representing more than 90 institutions, strengthen institutional structures facilitate development of new drugs and these individuals come from diverse and capacities, while championing tools for Chagas disease. By creating backgrounds including research, accessible, easy to administer an open, innovative, collaborative and academia, government, international treatments, as well as new tools for patient-oriented environment, the and national organizations, and diagnosis and monitoring of the disease. Chagas R& D Landscape Summary 2 PROGRESSES AND CHALLENGES IN THE 8 YEARS OF THE CHAGAS PLATFORM 3 THE CHAGAS PLATFORM 2016 PERFORMANCE Research Translational Development SURVEY 4 UPDATE ON CHAGAS DISEASE IN 2017 DDU Biomarkers Various 5 INTERVIEW WITH ASOCHAGAS Groups - COLOMBIAN PATIENTS’ ASSOCIATION Worldwide Adult BERENICE Benznida- 6 THE GLOBAL CHAGAS DISEASE COALITION GNF Fexinida- zole AT THE NEGLECTED TROPICAL DISEASES Eisai/Broad zole (ELEA/ SUMMIT IN GENEVA, APRIL 2017 Chagas DD GSK Chemo) 7 DRUG DISCOVERY IN ENDEMIC AREAS: Consortium DDU UPDATES FROM DNDi ’S LEAD OPTIMIZATION Pediatric LATIN AMERICA (LOLA) CONSOrtiUM CHICAMOCHA 2 Nifurtimox 8 BIOMARKERS OF CHAGAS DISEASE: (Bayer) TOWARDS A BETTER STRATEGY TO A NTD GSK Tres 9 DEVELOPMENT OF A PAEDIATRIC Cantos FORMULATION OF NIFUrtiMOX Celgene Pfizer CHICO - CLINICAL TRIAL BENDITA 10 BENDITA STUDY UPDATE UCSD SAR114137 10 PROGRESS WITH CLINICAL TRIALS FOR CHAGAS DISEASE IN COLOMBIA EU-FP7 Consortia 11 BERENICE UPDATE - PDE4NPD CHICAMOCHA 12 CHAGAS DISEASE IN THE UNITED STATES: 3 NEW DIRECTIONS, NEW THREATS LOAUS-LOUS-LOLA LSHTM Series from various STPH Pediatric 13 AN UPDATE ON THE STATUS OF CHAGAS sources ongoing LMPH Benznida- DISEASE IN THE UNITED STATES - Abbvie zole - GSK “Chagas” Box 14 COMPREHENSIVE CARE FOR CHAGAS DISEASE - Sanofi IPK 15 ACCESS TO DRUGS FOR CHAGAS DISEASE: - Celgene Dundee THE IMPOrtANCE OF ESTIMATING DEMAND - others Eskitis ATTACH research gaps Rio de Janeiro, May 2017 Editorial Progresses and challenges in the 8 years of the Chagas Platform Isabela Ribeiro and Sergio Sosa-Estani, dndi Civil society workshop held at the 2016 Chagas Platform Meeting In 2005, DNDi launched an agenda for Chagas • DNDi and the Platform provided support through disease focused on developing a pediatric technical consultancy during the registration process for formulation of trypanocidal drugs and a pediatric formulations of benznidazole in Brazil, Argentina, research portfolio of treatment alternatives for and other Latin American countries, and currently supports chronic Chagas disease. This was the forerunner for ongoing efforts to expand registration of the drugs and what would become the Platform for Clinical Research promote access plans to optimize the use of the in Chagas Disease, launched in 2009, which currently trypanocides Benznidazole and Nifurtimox. involves more than 300 stakeholders, including All this scientific exchange and encouragement has researchers from the public and private sectors, brought to DNDi its strategic orientation, allowing the patient organizations, and health services personnel. delivery of a pediatric formulation of benznidazole in The Platform’s has many significant accomplishments, such 2011, screening of thousands of compounds, and the as the ones highlighted bellow: definition of steps for the optimization of new candidate compounds. A phase I trial was conducted to evaluate • A profile for a target product for treatment of Chagas the safety of a drug combination, two phase II clinical disease, defined in 2010 and revised periodically (most trials were finalized, and there are two new trials recently in March 2015); currently under way. The current strategic plan includes • Led the process that helped achieve a consensus in two phase II clinical trials studying nine alternative the scientific community on a randomized clinical trial arms that will furnish options for phase III trials, to evaluate response to new trypanocidal drugs within a besides validating biomarkers of treatment response. maximum of two years, a design used by various groups to We will work in the Platform to seek coherence and evaluate triazole compounds; efficiency in clinical and preclinical studies in Chagas • Provided an environment for productive discussions on disease, and to advance and fill knowledge gaps for preclinical modelss; the development of new tools. While all these studies are underway, access to current trypanocidal drugs • The Platform was a facilitator for the standardization using the prevailing regimens is being promoted. and optimization of polymerase chain reaction (PCR) in the diagnosis and evaluation of the impact of We view the Platform as a dynamic organization that Chagas treatment; provides services together with strategic partners in the scientific and academic community and industry, • Significant contributions were made to the investigation acting as a facilitator with other stakeholders such as the of biomarkers for treatment response, especially with the Chagas Coalition, Ministries of Health, and PAHO-WHO, use of PCR, and in the evaluation of proteomics, multiplex in programs for access that allow care for persons with assays, and recombinant antigens; Chagas diseases to become an increasing reality, with • Supported the initial speculation for later creation and impact on a feasible path to the elimination of Chagas evolution of the Chagas patient’s associations, which gather disease as a public health problem. people affected by the disease and healthcare workers; 2 Newsletter n o . 7 Chagas Disease Clinical Research Platform Platform Evaluation of the Chagas Platform activities The Chagas 60 Platform 2016 50 40 Performance Survey 30 20 Marina Certo, dndi Latin America 10 Annual Workshops Technical Web Annual Since 2009, the Chagas Clinical Research meetings and trainings meetings Forum Newsletters Platform has been supporting the definition Excellent Good Regular Bad Terrible of a flexible and patient´s driven network. By facilitating a structured strategy of R&D and access To conclude, we emphasize that 43% of the survey initiatives for Chagas disease, it aims a change of the answers stated that members had started a cooperative diagnosis and treatment in Chagas disease paradigm partnership that led to a specific project, thanks to while enhancing capacity building and cooperation in Platform activities. In addition, 95.3% of the replies endemic and non-endemic countries. stated that the Platform influenced their work or in The Chagas Platform has been constantly expanding their organization’s performance, providing an indirect and consolidating itself through a collaborative or direct impact on their activities. Thereby, eight network of different stakeholders. The number of years after its creation, the Chagas Platform remains people involved in these activities has been growing as a main tool for knowledge-sharing, cooperation and constantly, totalizing 378 Web Forum members from 23 regular debates about the latest scientific and political countries in April 2017. The 2016 Annual Meeting had updates about Chagas disease, expanding community more than 270 attendees, exceeding previous meetings participating and strengthen capacities. by its larger number of participants and activities. In 2016, the Chagas Platform Performance Survey was Chagas Platform impact on carried out with its the members, receiving very positive it’s member’s work feedback from 86 answers. In this survey, it was possible to or their performance access the profiles of the Platform’s most active members. The results have shown that most of the members represent R&D institutions (38.1%), while National Health 4,7% Programs (21.4%), educational institutions (19%) and NGOs (15.5%) are also numerous. Although most of the CCRP researchers are currently working on clinical projects (50%), many are also dedicating themselves to 58,1% 37,2% access issues (19.2%). Most of the active members are female (59%) and about 41% have completed a master’s degree, while 40% are doctors. The great majority of members work in South America (73%); 12% are in Europe and other 12% in North America. Direct impact Indirect impact No impact Newsletter
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