BRISBANE, Calif., Aug. 08, 2017 (GLOBE NEWSWIRE) -- Humanigen, Inc. (OTCQB:HGEN), a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, today 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 U.S. Food and Drug Administration (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 U.S., 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 U.S.
Humanigen, Inc. (OTCQB:HGEN) 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 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 juvenile myelomonocytic leukemia (JMML). For more information, visit www.humanigen.com.
About Benznidazole and Chagas Disease
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.
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 our expectations for executing on the other key priorities and anticipated milestones described above. 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; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.