Humanigen Announces Completion of Bioavailability Study
Humanigen, Inc. recently announced it has completed enrollment and follow-up of subjects in its human bioavailability study for benznidazole. The bioavailability study is a key part of the company’s planned New Drug Application (NDA) package to the US FDA in the 505(b)(2) development program for benznidazole as a potential treatment for Chagas disease, a neglected tropical disease. The study’s main objective is to characterize the pharmacokinetic profile of benznidazole.
Analysis of the study has begun, and the company anticipates preliminary interpretation of the data by October. The company expects to have the final study report in the fourth quarter of this year.
“The completion of the bioavailability study is another example of the Humanigen team’s ability to execute and to continue to deliver on our program milestones and goals,” said Cameron Durrant, MD, Chairman and CEO. “Chagas disease is a neglected tropical disease with significant prevalence in the US, high unmet need, and unique and complex challenges, which we are working hard to potentially help address.”
Humanigen expects to submit its NDA in the first quarter of 2018. The company received clearance from the FDA in June for its Investigational New Drug (IND) application and earlier this year received positive guidance from the FDA supporting the company’s proposed 505(b)(2) regulatory pathway for benznidazole, enabling the company to use data obtained from previously conducted studies to demonstrate safety and efficacy in the treatment of Chagas disease within the US.
Humanigen, Inc. is a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases through innovative, accelerated business models. Lead compounds in the 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 juvenile myelomonocytic leukemia (JMML). For more information, visit www.humanigen.com.
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