Clinical study results of DAS181 against H1N1 influenza presented

Sep 14 2009

NexBio, Inc. announced today the presentation of two studies of DAS181 activity against H1N1 influenza and NAI-resistant influenza at the 2009 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting on Sunday, September 13, 2009, in San Francisco, CA. The work was performed in collaboration with researchers at the Centers for Disease Control and Prevention (CDC), University of Hong Kong, and Saint Louis University.

DAS181 (Fludase(R)) is an investigational broad spectrum drug candidate being evaluated in human clinical development for treatment and prevention of Influenza-Like Illness caused by all strains of influenza and parainfluenza. Unlike neuraminidase inhibitors (NAI), e.g. Tamiflu(R), which directly target the influenza virus ("pathogen target"), DAS181 works by inactivating the human receptor ("host target") for these viruses; thus, it may be less likely to encounter acquired resistance compared with currently-available antiviral drugs. Extensive, prolonged nonclinical influenza studies have not shown the development of any meaningful resistance. This approach may have advantages over mono-therapy or combination therapy which directly target the pathogen. Previously announced preclinical studies conducted in collaboration with the CDC and others have shown DAS181 to have significant therapeutic and prophylactic activity in in vivo animal models and in human ex vivo lung tissue for a highly virulent H5N1 (A/VN/1203/04) strain of influenza.

A "Late Breaker" presentation, entitled "Novel Swine-Origin A (H1N1) Influenza Viruses are Potently Inhibited by DAS181, a Sialidase Fusion Protein" examined in vitro, ex vivo, and in vivo models to evaluate the activity of DAS181 against multiple human novel 2009 influenza A/H1N1 viruses (Novel H1N1 or "Swine Flu"). The data presented at the meeting suggested that DAS181 exhibited potent inhibitory activity against these Novel H1N1 viruses in these different models.

The related presentation, entitled "In Vivo and In Vitro Activity of DAS181 Against NAI-Resistant Influenza Virus" examined the in vivo and in vitro activity of DAS181 against patient isolates of community-acquired seasonal influenza from the 2008-2009 influenza season. All isolates had the H274Y mutation associated with resistance to Tamiflu. DAS181 in vitro was an effective inhibitor of Tamiflu-resistant influenza virus. In addition, in vivo mouse challenge studies with another NAI-resistant strain demonstrated strong sensitivity to DAS181 treatment.

Both studies are presented by Ronald Moss M.D., Executive Vice President, Clinical Development and Medical Affairs. "Based on these encouraging data we are moving forward with our ongoing clinical development of DAS181, and we will continue to work closely with FDA, CDC, and NIH on this clinical program during the current pandemic," stated Dr. Moss. "Because of viral evolution, alternatives to current treatment strategies are needed to deal with potential drug resistance. DAS181 may play an important role for public health preparedness during influenza pandemics."