Merck today announced plans to initiate a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent posaconazole for the treatment of chronic Chagas disease. Chagas disease results from infection with the parasite Trypanosoma cruzi that is spread by biting insects. The disease is estimated to affect approximately eight million people in Latin America, of whom approximately 30-40 percent will develop serious cardiac disease, digestive disease, or both as a result of this infection. Recognized by the World Health Organization (WHO) as a neglected tropical disease, Chagas disease also is becoming an emerging health problem in non-endemic areas through migration of infected populations from endemic areas. Currently, only two drugs are approved for treatment: benznidazole and nifurtimox.
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"While significant progress has been made in recent years in the prevention of the transmission of this potentially life-threatening disease, no new drugs have been approved for the treatment of chronic Chagas disease in over three decades," said Roger J. Pomerantz, M.D., F.A.C.P., global franchise head for infectious diseases and senior vice president, Merck Research Laboratories.
In planning the study to evaluate posaconazole, Merck has consulted with international agencies and research organizations to identify the current medical needs and reach consensus on a study design for posaconazole in asymptomatic chronic Chagas disease. The proposed study is a randomized, placebo-controlled Phase II study of posaconazole oral suspension (400 mg twice daily) given for 60 days, either as monotherapy or concomitantly with benznidazole. Benznidazole monotherapy will serve as an active control. The study is planned to enroll 160 adult patients with chronic Chagas disease at several sites in South America and follow them for a total of 360 days. The study will utilize polymerase chain reaction (PCR) to evaluate the levels of Trypanosoma cruzi in blood samples as the primary endpoint for response to treatment. Safety will be monitored by an external independent Data and Safety Monitoring Board (DSMB) on an ongoing basis and the DSMB will make recommendations as appropriate. Results from the study are expected in 2012. If successful, Phase III clinical studies with posaconazole would follow. Merck looks forward to working with interested partners to facilitate access if posaconazole is shown to be beneficial in the treatment of chronic Chagas disease.