Altimmune Announces Positive Initial Data from Its HepTcell Phase 1 Study
HepTcell well tolerated in all cohorts
Initial data on secondary endpoint demonstrates T cell responses
GAITHERSBURG, Md., Dec. 21, 2017 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company, today announced it has completed dosing of its HepTcell Phase 1 study in chronic hepatitis B (NCT02496897). All doses were well tolerated, there were no hepatic flares, and no discontinuations. Additionally, the preliminary data showed evidence of dose dependent increases in cellular immune response to HBV antigens. The laboratory analysis is ongoing and full analysis of all data through the post dosing period will be available Q1 2018.
“Boosting virus-specific cellular immunity is a key target for curative treatment in chronic HBV infection,” said Professor Mark Thursz, professor of hepatology at Imperial College London and Chief Investigator for the HepTcell Phase 1 study. “The signs of HBV immune response in the blinded dataset are exciting and the results next year will be of great interest to the hepatology community. In addition, HepTcell’s safety profile was especially reassuring.”
The study, which was a double-blinded, placebo-control trial, enrolled 60 subjects with chronic hepatitis B who were HBeAg negative and well-controlled on licensed antivirals. Forty patients received one of two dose levels of HepTcell, with and without IC31 adjuvent; while twenty control patients received either placebo or IC31 alone. All patients received 3 injections 28 days apart, and will be followed for 6 months after the final dose.
Chronic hepatitis B is a persistent viral infection of the liver, which can put those afflicted with the virus at risk of death from cirrhosis of the liver and liver cancer. The virus is transmitted through contact with blood or other body fluids of an infected person. Worldwide, 240 million people are chronically infected, with over 1 million HBV related deaths attributed to the virus annually. Current approved therapies control, but do not eliminate, the HBV virus.
Altimmune is a clinical-stage immunotherapeutics company focused on the development of products to stimulate robust and durable immune responses for the prevention and treatment of disease including NasoVAX, a Phase 2 seasonal influenza vaccine candidate, and HepTcell, a Phase 1 immunotherapeutic candidate for the potential cure of chronic hepatitis B. The company also has two United States government funded, next-generation anthrax vaccine candidates that are intended to improve protection and safety while having favorable dosage and storage requirements compared to other anthrax vaccines.
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. (the “Company”) may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: realizing the benefits of the merger between Altimmune, Inc. and PharmAthene, Inc.; clinical trials and the commercialization of proposed product candidates (such as marketing, regulatory, product liability, supply, competition, dependence on third parties and other risks); the regulatory approval process; dependence on intellectual property; the Company’s BARDA contract and other government programs, reimbursement and regulation; and the lack of financial resources and access to capital to fund proposed operations. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Form 10-K filed March 14, 2017, Form 10-Q filed August 14, 2017 and in the Form 8-K filed August 17, 2017, which are available at www.sec.gov.
President and CEO
LifeSci Advisors, LLC