KaloBios Submits IND Application to FDA
KaloBios Pharmaceuticals, Inc. recently announced it has submitted an Investigational New Drug (IND) application to the US FDA for benznidazole for the treatment of Chagas disease, a neglected tropical disease. The IND application is a critical part of the company’s previously outlined plan to advance benznidazole for potential US approval for Chagas disease.
“Our team continues to deliver on key milestones, progressing benznidazole on an accelerated timeline to an expected filing of a New Drug Application in the first quarter of 2018,” said Cameron Durrant, MD, Chairman and CEO of KaloBios. “This work addresses enduring unmet need. People infected with Chagas disease carry a dramatic and significant increased risk of death. According to a recent PLOS Neglected Tropical Diseases paper, those infected have an almost 18 times higher risk of death from Chagas-related cardiac issues than those not infected.”
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 (often called “kissing bugs”). According to the Centers for Disease Control and Prevention (CDC), an estimated 300,000 people in the United States are infected with Chagas disease, which, if left untreated, can lead to serious and potentially life-threatening cardiovascular, gastro-intestinal and neurological complications. Benznidazole is the current preferred treatment for Chagas disease in other parts of the world but is not currently approved by the FDA in the US.
KaloBios Pharmaceuticals, Inc. is an emerging biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases through innovative and responsible business models. Lead compounds in the KaloBios portfolio are benznidazole for the potential treatment of Chagas disease in the US, and the proprietary monoclonal antibodies, lenzilumab, and ifabotuzumab. Lenzilumab has potential for treatment of various rare diseases, including hematologic cancers, such as chronic myelomonocytic leukemia (CMML) and potentially juvenile myelomonocytic leukemia (JMML). For more information, visit www.kalobios.com.
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