Market Opportunity

Over the last several decades, the emergence and spread of antimicrobial resistance has compromised the effectiveness of many of the drugs doctors use to treat both common and severe infections. This has resulted in more difficult and costly treatment, longer hospital stays, higher risk of complications and an increase in – historically preventable – deaths. Without effective antibiotics, modern medicine becomes untenable, where surgery, chemotherapy and other procedures are no longer possible. Given the severity of this crisis, the World Health Organization has identified antibiotic resistance as one of the world’s greatest healthcare challenges and, as its theme for World Health Day 2011, issued a call to action to combat the rise of antibiotic resistance.

The epicenter of this crisis is occurring in hospitals, which have become incubators for antibiotic resistant infections, with over 70% of hospital bacterial infections being resistant to one or more classes of antibiotics. In the U.S. alone, 90,000 deaths are attributable to the more than 2 million hospital-acquired infections each year (CDC). In addition to the significant mortality and morbidity, the cost of hospital acquired infections is substantial, adding $16,000 to the cost of each patient’s care and in excess of $20 billion in additional direct medical costs to U.S. hospitals. Globally, the World Health Organization reports that hospital infections affect hundreds of millions of patients worldwide each year, with more than 1.4 million people becoming seriously ill or dying from such infections.

Methicillin-resistant Staphylococcus aureus (MRSA) is the most prevalent antibiotic resistant bacterial infection worldwide. It is estimated that MRSA kills 19,000 people every year in the United States and a similar number in Europe – more deaths than are caused by emphysema HIV/AIDS, Parkinson’s disease or homicides. Of even more concern are multidrug-resistant (MDR) gram-negative infections, such as Klebsiella pneumoniae, Acinetobacter baumanii, Pseudomonas aeruginosa, and Enterobacter species, because there is a very limited armamentarium of antibiotics to treat them. The rapidly increasing prevalence of infections caused by aggressive MRSA and multidrug-resistant (MDR) gram-negative strains has limited the effectiveness of many commonly used classes of antibiotics and created a critical unmet medical need.

Recently a new form of resistance has emerged that has clinicians worried. In 2010 researchers first reported infections involving New Delhi metallo-beta-lactamase, or NMD-1, an enzyme that makes the microbes resistant to most, if not all, antibiotics including penicillins, cephalosporins, and carbapenems. One of the major concerns is the ability of this antibiotic-resistant gene to spread across bacterial species of bacteria. Since then, infections with the NMD-1 resistant gene have been documented in two dozen countries across the world, from North America to Europe to Asia. More recently, researchers have even found bacterial with the NMD-1 resistant gene in drinking water and sewage samples in a major city in India.

Ironically, while antibiotics with novel mechanisms of action are urgently needed to combat the growing array of multidrug-resistant pathogens, the discovery and development of new antibiotics has slowed to nearly a halt. The number of new antibiotics approved by the FDA has steadily declined every year since 1980. This is largely the result of pharmaceutical companies shifting their focus away from drug discovery for acute indications, such as bacterial infections, to economically more attractive chronic indications, such as high blood pressure or diabetes. According to the Infectious Diseases Society of America, only two large pharmaceutical companies still have strong and active antibiotic research and development program. Two decades ago there were nearly 20. In addition, the classic approach to discovering new antibiotics has identified all the easier targets resulting in a lack of new targets and poor R&D productivity. Drug discovery efforts have yielded increasingly-fewer novel classes of antibiotics with most antibiotics in clinical development being derivatives of just two existing classes of drugs. All this has resulted in a pipeline for new antibiotics that many feel is running dry.

The continual evolution of drug-resistant pathogens, combined with the expanding population of severely ill patients at risk for hospital-acquired infections, and the rising incidence of these infections will continue to drive the need for novel antibiotics. Indel Therapeutics is dedicated to developing new drugs to address this global health crisis caused by antibiotic resistance.