Benznidazole IND for Chagas Disease Receives Clearance by FDA
Open IND is a significant step to advancing the benznidazole development program
- Company remains on track to submit a New Drug Application in the first quarter of 2018
BRISBANE, Calif., June 27, 2017 (GLOBE NEWSWIRE) -- KaloBios Pharmaceuticals, Inc. (OTCQB:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, today announced 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.
“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. Earlier this year, the company announced it received positive guidance from the FDA, supporting the company’s proposed 505(b)(2) regulatory pathway for benznidazole using data obtained from previously conducted studies to demonstrate safety and efficacy in the treatment of Chagas disease within the U.S. Upon FDA approval, benznidazole may be eligible for a neglected tropical disease priority review voucher (PRV), based on criteria specified by the Federal Food, Drug, and Cosmetic (FD&C) Act.
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"). An estimated 350,000 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. According to a May 2017 PLOS Neglected Tropical Diseases paper, those infected have an almost 18 times average higher risk of death from Chagas-related cardiac issues than those not infected. 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 U.S.
About KaloBios Pharmaceuticals, Inc.
KaloBios Pharmaceuticals, Inc. (OTCQB:KBIO) 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 U.S., 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.
This release contains forward-looking statements that are intended to be subject to protection afforded by the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations as to the timing for submission of our NDA for benznidazole and the possibility of receiving a PRV if FDA approval is obtained. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, our lack of profitability and the need for additional capital to operate our business as a going concern; the uncertainties inherent in the development and launch of any new pharmaceutical product; the acceptability to FDA of a 505(b)(2) development pathway for approval of benznidazole using data drawn from previously conducted studies and the various risks and uncertainties described in the "Risk Factors" and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.
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Released June 27, 2017