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A monoclonal antibody therapeutic drug, a novel approach to treating patients with influenza, will advance in development with funding from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR).
No monoclonal antibody antiviral drugs to treat patients with influenza have been approved by the Food and Drug Administration (FDA). Monoclonal antibodies bind to specific parts of the virus, neutralizing the virus and decreasing the amount of virus in the body.
The drug VIS410 is being developed by Visterra Inc. of Cambridge, Mass., and targets a part of the influenza virus that is common to a wide range of flu strains. The target area evolves much more slowly than areas targeted by currently approved drugs, which could allow VIS410 to be effective against flu strains that become resistant to current antiviral drugs.
“Having multiple antiviral treatment options available for influenza is essential to saving lives in a pandemic and every day,” says Robin Robinson, PhD, director of ASPR’s Biomedical Advanced Research and Development Authority (BARDA) whose office will oversee the project. “Developing antiviral drugs that work against many strains of influenza provides a cost-efficient way to boost pandemic preparedness and at the same time potentially alleviate the suffering of hundreds of thousands of people who are hospitalized with influenza every year.”
Under a 40-month, $29.1 million agreement with BARDA, Visterra Inc. will conduct clinical studies of safety and efficacy of VIS410, manufacture materials for use in clinical studies, and optimize manufacturing processes. This work will provide support and data needed for the company to submit a request for FDA review and approval of the drug.
The studies also will seek to determine the drug’s efficacy when administered more than 48 hours after the onset of influenza symptoms and to rule out side effects. Current treatment options work best when administered within 48 hours of symptom onset.
Pre-clinical studies suggest that VIS410 may be more effective than currently approved antiviral drugs and could be safe and effective in treating patients for whom influenza poses high risks, such as the elderly, children, and those with chronic conditions such as chronic obstructive pulmonary disease or heart disease.
The contract between BARDA and Visterra Inc. could be extended up to a total of five years and $204.5 million. If the contract is extended, the company will conduct larger clinical studies of the drug’s efficacy in severely ill and hospitalized patients including children.
If full development is successful, the drug would provide another treatment option for patients who are hospitalized due to seasonal or pandemic influenza infections. In the United States, more than 200,000 people are hospitalized each year due to seasonal flu complications, and seasonal influenza contributes to approximately 36,000 deaths annually.
The new antiviral monoclonal antibody development project is part of BARDA’s integrated portfolio for advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats. In addition to pandemic influenza, these threats include chemical, biological, radiological, and nuclear agents, emerging infectious diseases, and antimicrobial resistance.