Chagas disease: Benznidazole IND receives FDA clearance

In a follow-up on a report on KaloBios Pharmaceutical’s Chagas disease drug, benznidazole, the California based biopharmaceutical company announced today its Investigational New Drug (IND) application for benznidazole is open, and a key part of the program can proceed as planned toward gaining potential approval as a treatment for Chagas disease, a neglected tropical disease.

Kissing bug next to penny
Image/Rachel Curtis-Hamer Labs

Benznidazole is an oral anti-parasitic medication used in the treatment of Chagas disease, caused by a protozoan parasite Trypanosoma cruzi carried and transmitted by triatomine insects, aka the kissing bugs.

LISTEN: Chagas disease: An interview with Patricia Dorn, PhD

“We have taken big steps over the past year since we brought KaloBios out of bankruptcy, consistently delivering on our projected milestones, building momentum with this challenging but important program and transforming to operational excellence despite many legacy obstacles,” said Cameron Durrant, MD, chairman and CEO of KaloBios. “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.”

The U.S. Food and Drug Administration (FDA) confirmed acceptance of the company’s benznidazole IND on May 26, 2017, and the IND became effective 30 days after that date.

The benznidazole program remains on track for a New Drug Application (NDA) submission in the first quarter of 2018.

Related: 

• Chagas disease: UTEP scientists granted patent for first ever vaccine
• Dr. Peter Hotez on World Chagas Day 2017
• Chagas disease vector spread linked to cardboard boxes: Study
• Kissing bugs found in more than half the US: What is Chagas disease?
• Chagas parasite, T. cruzi, ‘widespread’ in Texas kissing bugs: Study