• Investigational new drug (IND) application on track to be submitted in May 2017
  • Manufacturing preparations in line to produce tablets, clinical batches produced
  • Company anticipates filing new drug application (NDA) in first quarter of 2018

BRISBANE, Calif., April 06, 2017 (GLOBE NEWSWIRE) -- KaloBios Pharmaceuticals, Inc. (OTC:KBIO), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, today provided an update on the company's progress advancing its lead program benznidazole for the treatment of Chagas disease, a neglected tropical disease.

"We continue to execute on our internal deadlines and remain on track for the advancement of benznidazole for the significant unmet need of Chagas disease here in the U.S.," said Cameron Durrant, MD, chairman and CEO, who today is also taking part in the International Society for Neglected Tropical Diseases (ISNTD) Chagas conference in Washington, D.C. Visit ISNTD Chagas for more information.

The company has made significant progress advancing its development plan for benznidazole as a potential U.S. treatment for Chagas disease, including:
  • Regulatory: The company is on track to submit its IND with the Food and Drug Administration (FDA) in May 2017. Future meetings with the FDA are expected to provide further refinement of the development plan. 
  • Manufacturing: Batches of the drug are complete and prototype tablets have been made. The company is on schedule for the delivery of final tablets. Work is also underway to develop efficiencies and begin scale-up for manufacturing processes. 
  • Clinical Data: The company has secured safety and efficacy databases necessary for its regulatory dossier. In January 2017, the FDA confirmed the acceptability of a 505(b)(2) development pathway using data drawn from previously conducted studies.

Overall, these activities are expected to support the filing of an NDA with the FDA for benznidazole in the first quarter of 2018.

If you liked this article you might like

KaloBios Pharmaceuticals, Potash and Radian: Doug Kass' Views

Stocks Slip on 2016 Outlook of Middling Economic Growth

Energy Lags Wall Street as Crude Oil Spirals Lower

KaloBios Looks to Restructure While Under Court Protection in Delaware

KaloBios Pharmaceuticals (KBIO) Files For Bankruptcy, Stock Delisted From Nasdaq