At the Annual Meeting of the Global Chagas Disease Coalition in Barcelona, Spain, Novartis announced that it is joining the Coalition as a member contributor. In addition, the company announced its commitment to launch a multinational, prospective, randomized study with heart failure drug, Entresto® (sacubitril / valsartan), in people with chronic Chagas cardiomyopathy, one form of heart failure with reduced ejection fraction. This is the first definitive morbidity and mortality study to assess a potential therapy for cardiac disease in this underserved patient population.
"Today marks another milestone in our longstanding commitment to the fight against neglected tropical diseases, and we are proud to partner with the Global Chagas Disease Coalition and its members to help improve access to diagnosis and reimagine treatment for people with Chagas disease," said Patrice Matchaba, Group Head, Global Health and Corporate Responsibility at Novartis. "It is only by joining forces that we can succeed in bringing our innovation to the people that need it."
The clinical trial will assess the efficacy and safety of Entresto vs. enalapril and is expected to start within 2019, with the aim of recruiting approximately 900 patients with confirmed Chagas disease in Latin America. The primary endpoint is time to occurrence of a composite of cardiovascular events, including cardiovascular death or first hospitalization due to heart failure. This definitive study follows an exploratory post hoc analysis from the PARADIGM-HF trial[6], which suggested that Entresto may have beneficial effects in people with chronic Chagas cardiomyopathy and heart failure with reduced ejection fraction.
At the same time, Novartis is working with stakeholders in endemic countries to co-develop tailored access-to-medicine programs and health system strengthening strategies to help ensure lower-income patients suffering from chronic Chagas cardiomyopathy can benefit from the best available treatment.
Chagas disease, also known as American trypanosomiasis, is a potentially life-threatening neglected tropical disease estimated to affect approximately six million people globally and is responsible for approximately 12 000 deaths annually[1],[2],[3]. The disease is endemic in 21 Latin American countries, where it is the second leading cause for developing chronic heart failure[7]. Due to population mobility, in the past decades, Chagas disease has been increasingly detected in the United States, Canada, and many European and some Western Pacific countries[3]. Chagas cardiomyopathy is the most important clinical manifestation of the disease, resulting in the majority of morbidity and mortality[4]
"We are pleased to welcome Novartis as one of our member contributors," said Javier Sancho, Coordinator of the Global Chagas Disease Coalition. "It is only by openly sharing our experience and knowledge and fostering synergies that we can hope to achieve our common goal of controlling and potentially eliminating Chagas disease."
Novartis is also taking steps to advance research efforts around the disease and is committed to providing mentorship opportunities for scientists from Latin America to help strengthen capacity for relevant research regionally. The Novartis Institute for Tropical Diseases (NITD), the Genomics Institute of the Novartis Research Foundation (GNF) and collaborators have developed a promising portfolio of novel drug candidates for the treatment of kinetoplastid diseases. The proteasome inhibitor LXE408 was recently advanced as a promising drug candidate for the treatment of visceral leishmaniasis[8]. This novel mechanism of action is also being explored for other indications, including Chagas disease.
In addition, Novartis is partnering with the World Heart Federation to develop an end-to-end roadmap for addressing Chagas disease. The final roadmap is expected to be launched within 2019. In parallel, we are working together with different stakeholders in Latin American countries, such as Arg...
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