KaloBios Pharmaceuticals Inc. of California, specializing in rare and neglected diseases, recently obtained FDA clearance for its oral anti-parasitic medication benznidazole designed to combat Chagas disease, a tropical malady transmitted to humans by insects.
The firm’s Investigational New Drug (IND) application open status confirmed in May goes a long way towards attaining eventual approval as treatment for Chagas disease in the U.S., company representatives stated.
“We have taken big steps over the past year … building momentum with this challenging but important program and transforming to operational excellence despite many legacy obstacles,” KaloBios CEO Dr. Cameron Durrant said. “The open IND allows us to move into what we expect to be the latter half of our benznidazole program for Chagas disease, a silent killer that affects more than 350,000 people in the U.S.”
Benznidazole is now on track for the next step, a New Drug Application, in early 2018.
Chagas disease, also called American Trypanosomiasis, is named for a Brazilian physician who discovered it in 1909. It is caused by the Trypanosoma cruzi parasite and is spread mainly by insects. Approximately 6 million individuals worldwide have contracted it, mostly in Latin America. Symptoms include fever, enlarged lymph nodes and headache.