HHS funding development of groundbreaking influenza drug

The federal government is backing the development of new influenza drug, which early studies suggest may be a game changer in treating the viral infection that is responsible for over 36,000 deaths annually in the U.S. alone. HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR) has announced that it will be funding the development of a new type of influenza drug that takes a novel approach to treating individuals suffering from influenza. The drug, VIS410, is a monoclonal antibody therapeutic drug, which binds to specific part of a virus with the aim of decreasing the amount of the virus present the body. No monoclonal antibody antiviral drug has ever been approved by the FDA to treat individuals with influenza.

Targeted Treatment

Visterra, Inc. is developing VIS410, which targets parts of the influenza virus that is commonly present in a wide range of flu strains. The targeted area has been found to evolve much more slowly than areas that are targeted by drugs that have been approved by the FDA. As a result, it is hoped that VIS410 could be effective against strains that are resistant to available antiviral drugs.

New Technology

Visterra, which is backed by various investors, including the Bill & Melinda Gates Foundation, is a biotechnology company that identifies unique disease targets through its “Atomic Interaction Network (AIN) analysis,” which is described as “computational tools and techniques.” Visterra has initially focused on infectious diseases that have complex and evolving properties with the potential to mutate. The company uses its Hierotope™ Platform to identify an area on a target protein, glycoprotein or glycan that is fundamental to its structure, which then becomes the target for which a therapeutic is developed.

Agreement

ASPR’s Biomedical Advanced Research and Development Authority (BARDA) will be overseeing the 40-month, $29.1 million agreement. As part of the agreement, Visterra will conduct clinical studies of VIS410’s safety and efficacy and will manufacture materials used in the clinical studies. The company will also optimize the manufacturing processes. Visterra’s work will provide data and support for the company when requesting FDA review and approval for the drug. The contract can be extended up to five years at a cost of $204.5 million. If the Visterra’s contract is extended, it will conduct larger clinical studies of the drug’s efficacy in treating severely ill individuals and hospitalized patients.

Treatment Timing

The clinical studies will also examine the drug’s efficacy when administered more than 48 hours after the beginning of influenza symptoms. This is notable because current treatments work best when administered within 48 hours of the onset of symptoms.

Users

Pre-clinical studies have suggested that the drug may be more effective than currently available FDA-approved drugs. The studies also suggest that the drug could be safe and effective for use in treating individuals for whom influenza may pose the highest risks, such as the elderly, children, or those with chronic conditions including heart disease. If the drug is successfully developed, it may provide a treatment for patients who are hospitalized as a result of seasonal or pandemic influenza infections. Each year, more than 200,000 individuals are hospitalized due to flu complications and 36,000 people die as a result of the seasonal flu.

Integrated Portfolio

The new antiviral monoclonal antibody development project is yet another part of BARDA’s integrated portfolio that seeks to advance the research, development, and manufacturing of vaccines, drugs, and diagnostic tools for public health emergencies.

Robin Robinson, Ph.D., Director of ASPR’s BARDA said, “Having multiple antiviral treatment options available for influenza is essential to saving lives in a pandemic and every day.” Robinson further stated, “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.”