SAN DIEGO, March 29 NexBio, Inc. announced today the publication in the Journal of Infectious Diseases of a preclinical study suggesting that treatment with DAS181 (Fludase®) may reduce the risk of secondary bacterial pneumonia following influenza virus infection. DAS181 is a broad spectrum host-targeted investigational drug candidate for treatment and prevention of Influenza-Like Illness (ILI) and has shown preclinical activity against numerous strains of influenza and parainfluenza virus. DAS181 blocks entry of these viruses into cells of the respiratory tract. DAS181 is currently being studied in a human phase II clinical trial funded by the National Institute of Allergy and Infectious Diseases (part of the National Institutes of Health) and monitored by an independent Data Safety Monitoring Board. More information about the study may be found at http://www.das181flustudy.com/ as well as at www.clinicaltrials.gov.
Unlike neuraminidase inhibitors (NAI) such as Tamiflu® (oseltamivir), as well as vaccines, which both target the influenza virus ("pathogen target"), DAS181 works by inactivating the human sialic acid receptors ("host target") for these viruses; thus, drug resistance may be less likely to emerge compared with currently-available antiviral drugs. Earlier publications have described DAS181's activity for Pandemic Influenza A(H1N1) and highly pathogenic avian H5N1, as well as against IFV resistant to NAIs such as Tamiflu®. In addition, NexBio has recently presented data from three independent studies in animal models of asthma, done with academic collaborators, demonstrating DAS181's potential benefit for airway diseases.
Secondary infection with bacteria such as Streptococcus pneumoniae (pneumococcus), occurring after influenza virus (IFV) infection, is a major public health concern associated with an increased risk of death. Historical records suggest that a large number of influenza deaths occurring during the pandemics of 1918, 1957, and 1968 were the result of secondary bacterial pneumonia and not the initial influenza infection itself. Complications caused by secondary bacterial infections continue to be a significant cause of morbidity and mortality during seasonal influenza, and they represent an even more serious threat during pandemics, such as Pandemic Influenza A(H1N1).
In the paper entitled "Sialidase-Based Anti-Influenza Virus Therapy Protects against Secondary Pneumococcal Infection" mice were challenged with a lethal dose of IFV (H1N1 or H3N2). Mice were then treated with DAS181 followed by a challenge with pneumococcus, a common cause of secondary pneumonia. In these IFV-infected mice, treatment with DAS181 inhibited influenza virus, prevented weight loss and prevented bacterial pneumonia, thereby significantly prolonging survival. It is hypothesized that desialylation by DAS181 protects animals by inhibiting IFV infection and subsequently reducing bacterial colonization. As well, by limiting the airway epithelial damage caused by IFV infection, DAS181 treatment may protect the epithelium from inflammation and thereby prevent secondary bacterial infection.
"These results are important because of the danger posed by secondary bacterial infection in patients with influenza, including those infected with the H1N1 pandemic virus. Indeed, CDC showed early on in the H1N1 pandemic that concurrent bacterial infection was seen in 29% of fatal cases, particularly with pneumococcus," commented Dr. Fang Fang, NexBio's President of Research & Development. "Unique among licensed influenza drugs and those in clinical development, DAS181 uses a Host-Oriented Therapeutic strategy. We are encouraged by these preclinical findings that suggest that the significant anti-viral activity offered by this approach is also associated with protection from potentially lethal bacterial infection," Dr. Fang added.
NexBio, Inc. is a privately held clinical-stage biopharmaceutical company located in San Diego. NexBio's mission is to save lives and to improve the quality of life by creating and commercializing novel, broad-spectrum biopharmaceuticals to prevent and treat current and emerging life-threatening diseases. DAS181 (Fludase®) is an investigational drug undergoing phase II clinical development, directed to the treatment and prophylaxis of influenza-like illness caused by any and all strains of influenza, including pandemic strains, and parainfluenza (which may cause serious respiratory illness similar to influenza and for which there is no approved vaccine or therapeutic). DAS181 is a host-targeted inhaled recombinant fusion protein that inactivates viral receptors on the cells of the human respiratory tract, thereby treating and preventing viral infection. The DAS181 development program is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, under BAA Contract HHSN266200600015C and grant U01-AI070281. Sepcidin(TM), invented and developed by NexBio, is a parenteral protein at lead optimization stage, directed to the treatment of viral hemorrhagic fevers, bacterial biothreat agents and sepsis. TOSAP® is a technology invented and developed by NexBio and is used to formulate DAS181 for inhalation, as well as to make microparticles from virtually any type of molecule. TOSAP is offered for the formulation of compounds of partners, under license. SAFRAN(TM) is a technology invented and developed by NexBio, used to formulate siRNA for parenteral delivery.
For more information about NexBio, Inc., please visit http://www.nexbio.com
* FDA has yet to approve the name Fludase.
This release contains forward-looking information about the research and development program of NexBio and the potential efficacy of product candidates that might result from programs that involve substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development activities; decisions by regulatory authorities regarding whether and when to permit the clinical investigation of or approve any drug applications that may result from the programs as well as their decisions regarding labeling and other matters that could affect the commercial potential of product candidates that may result from the program; and competitive developments.
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