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NexBio, Inc. Reports Safety and Significant Antiviral Activities of DAS181 (Fludase)* from a Dose-Ranging Phase II Clinical Trial



8/15/2011 10:46:07 AM

SAN DIEGO, Aug. 15, 2011 /PRNewswire/ -- NexBio announced top line data from a Phase 2 clinical trial of DAS181, an investigational drug for treatment and prophylaxis of Influenza-Like Illness (ILI) caused by all types and strains of influenza and parainfluenza viruses, including pandemic influenza strains. In a double-blind, placebo-controlled, Phase 2 trial of otherwise healthy adults infected with influenza virus, treatment with DAS181 resulted in a significant reduction in patients' influenza viral loads. This trial was funded by the Division of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health.

In addition to assessing the safety of DAS181, the primary objective of the study was to assess the effect of DAS181 on reducing the viral load, or the amount of influenza virus, in respiratory secretions, as recommended in the FDA's April 2011 Guidance to Industry. The patient sample size for this trial was based on achieving a significant difference in virologic outcomes. A total of 297 subjects with ILI were enrolled and randomized in equal parts to receive either placebo, a single 10 mg dose of DAS181, or three once-daily 10 mg doses of DAS181. An independent Data Safety Monitoring Committee (SMC) monitored the trial to ensure the safety of subjects. The investigational drug was well tolerated. Four serious adverse events occurred (two in placebo patients and two in the single dose treatment group). None of these was deemed to be associated with use of DAS181.

The trial, which ran through two Northern hemisphere influenza seasons and one Southern hemisphere influenza season, enrolled rapid influenza antigen test positive patients infected with influenza A strains, including Pandemic H1N1 (2009) and H3N2, or Influenza B strains. Influenza infection was subsequently confirmed by Polymerase Chain Reaction (PCR) in 177 of the 297 enrolled patients. An independent laboratory used quantitative PCR to determine the amounts of influenza virus in blinded samples.

Top line virologic results show that once-daily treatment for three days with 10 mg DAS181 resulted in a significant reduction of viral load when compared to placebo over the first 24 hours (p<0.002), first 48 hours (p<0.009) and from Day 1 to 5 (p<0.008). In addition, once-daily DAS181 treatment for three days also significantly decreased time to achieve a sustained reduction in viral shedding when compared to placebo (p<0.003). In spite of the fact that the trial sample size was neither designed nor powered to demonstrate a significant effect on clinical endpoints, a trend of greater improvement over time in total symptom scores was observed in DAS181 treatment groups. Additional virologic and clinical analysis is ongoing, and a final Clinical Study Report will be generated. The company has received an acceptance for a Late Breaker oral presentation on the topline results of this clinical trial at the ICAAC meeting (Interscience Conference on Antimicrobial Agents and Chemotherapy) in September, 2011.

Dr. Roy Steigbigel, Professor of Medicine and Infectious Diseases at Stony Brook University, the Principal Investigator of the trial commented, "I am very pleased with the outcome of this trial and would like to thank all the patients and investigators. The promising top line results, especially significant viral load reduction data, warrant further clinical investigation on DAS181 as an important option for the treatment and prevention of influenza. Influenza viruses continue to mutate and new treatment options are needed for this unmet medical need. Recent reports have noted increases in swine flu viral resistance to multiple neuraminidase inhibitors (NAIs) including Tamiflu® and Relenza®."

"These positive clinical results with our flagship product are very exciting and mark an important initial corporate milestone," noted Fang Fang, M.D., Ph.D., President of R &D of NexBio. "We are determined to make a positive and significant impact in protecting the public and saving lives during an upcoming influenza pandemic. I want to thank all my NIAID colleagues who have not only provided the funding to support DAS181 development from its infancy, but who have also worked with us collaboratively to obtain these important results," Dr. Fang added.

The nonclinicaldata previously reported with DAS181 include antiviral activity against not only influenza virus but also parainfluenza virus, as well as potential anti-asthma effects. Currently, there is no drug or vaccine for parainfluenza treatment or prevention. NexBio will continue to develop the broad clinical applications of DAS181.

Contact:

Mang Yu, Ph.D.
Chief Executive Officer
NexBio, Inc.
10665 Sorrento Valley Road
San Diego, CA 92121
Phone: (858) 452-2631
myu@nexbio.com

ABOUT NEXBIO

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 with a Phase 2 trial completed that consists of an inhaled recombinant fusion protein. It inactivates viral receptors on the cells of the human respiratory tract, thereby preventing and treating infection by influenza virus, including potential pandemic strains, and by parainfluenza virus (which may cause serious respiratory illness similar to influenza and for which there is no approved vaccine or therapeutic). 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, invented and developed by NexBio, is a recombinant protein drug candidate at pre-clinical lead optimization stage, directed to the treatment of sepsis/SIRS, viral hemorrhagic fevers, bacterial biothreat agents. TOSAP®, a technology invented and developed by NexBio, is used to formulate DAS181 for inhalation, as well as to make microparticles from virtually any type of large and small molecule, and combinations of molecules. TOSAP is offered for the formulation of compounds of partners, under license.

For more information about NexBio, Inc., please visit http://www.nexbio.com

* FDA has yet to approve the name Fludase

SOURCE NexBio, Inc.


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