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Medical Need - Overview

NovaDigm is determined to address fungal and bacterial infections with innovative vaccines. Infectious disease remains the second leading cause of death in the world and the third leading cause of death in the United States. Our lead product candidates target the fungal pathogen Candida and the bacterial pathogen Staphylococcus aureus (S. aureus), including methicillin-resistant S. aureus (MRSA). Candida and S. aureus routinely colonize human hosts and typically cause no infection. However, exposure to these pathogens in the community setting can lead to skin and mucosal infections that can become recurrent in some patients, though they are generally not life-threatening. In a hospital setting, infections by Candida and S. aureus are more likely to become invasive, spreading through the blood to critical organs. Invasive Candida and MRSA  infections have unacceptably high mortality rates of about 30-40% and 15%, respectively, despite the availability of several antifungal and antibacterial drugs.1,2,3 Several risk factors lead to these serious invasive infections in hospitals, including the underlying diseases and immunocompetence of patients, colonization by Candida or S. aureus, the use of invasive medical devices such as venous catheters and feeding tubes, recent surgery and the recent use of broad-spectrum antibiotics.4 Given the overlapping risk factors for life-threatening Candida and S. aureus infections, the increasing worldwide prevalence of these risk factors and the increasing difficulty in treating these infections, NovaDigm's NDV-3 addresses significant and unmet medical needs for hospitalized patients, as well as patients in the community setting.


  1. Cleveland AA, Farley MM, Harrison LH, Stein B, Hollick R, Lockhart SR, Magill SS, Derado G, Park BJ and Chiller, TM, Changes in Incidence and Antifungal Drug Resistance in Candidemia: Results from Population-Based Laboratory Surveillance in Atlanta and Baltimore, 2008-2011. Clin. Inf. Dis. 2012; 55(10): 1352-61.
  2. Kett DH, Azoulay E, Echeverria PM, Vincent J-L, and for the EPIC II Group of Investigators, Candida Bloodstream Infections in Intensive Care Units: Analysis of the Extended Prevalence of Infection in Intensive Care Unit Study. Crit. Care Med 2011; 39(4): 665-670.
  3. U.S. Centers for Disease Control, Active Bacterial Core Surveillance Report, MRSA, 2011 (http://www.cdc.gov/abcs/reports-findings/survreports/mrsa11.pdf).
  4. Safdar N, and Maki DG, The Commonality of Risk factors for Nosocomial Colonization and Infection with Antimicrobial-Resistant Staphylococcus aureus, Enterococcus, Gram-Negative Bacilli, Clostridium difficile and Candida. Ann Intern Med 2002; 136: 834-844.