In cases of severe bacterial infections, despite adequate treatment, high morbidity and mortality in patients still remains high. Antibiotic therapy exhibits limited benefit due to a severe inflammatory response triggered by toxins and bacterial components that culminates in tissue necrosis and organ failure.
The fast and growing development of resistance to antibiotics further complicates the problem.
Atox Bio products offer several key advantages:
- Broad-spectrum activity
- Modulation of the inflammatory response
- Avoidance of drug resistance
- Fast-acting
- Excellent safety profile with no agonistic or immunogenic effects
Atox Bio's main clinical program targets several of the most severe infections:
Necrotizing soft tissue infections (NSTI)
NSTI is a life-threatening, rapidly progressing soft-tissue infection primarily involving the superficial fascia. It is a severe medical condition with high morbidity and mortality that requires a multi disciplinary approach to care .The infection tracks along the fascial planes, causing thrombosis of blood vessels running through the fascia with resulting necrosis of the skin, subcutaneous fat and even muscle. Broad anti-bacterial therapy is inadequate and there are currently no available therapeutics approved for this indication. The principles of management include early diagnosis with prompt and repeated aggressive surgical debridement, aggressive resuscitation and physiologic support, in addition to antimicrobial drugs. As neither surgical debridement nor antibacterial therapy directly address the immunological pathogenesis of NSTI, reducing the host inflammatory response with AB103 could lead to important clinical benefits in both morbidity and mortality. Outbreaks of a severe and often deadly form of necrotizing soft tissue infection are caused by Streptococcus pyogenes, the "flesh-eating bacteria". The incidence of NSTI is 21,000cases/year in the US, with overall case fatality of up to 35%. AB103 has been studied extensively in an animal model of Gram-positive necrotizing soft tissue infection. AB103 conferred substantial survival benefit and resolved the systemic inflammatory response and tissue damage at the infection site. Based on extensive pre-clinical data, Atox Bio believes that AB103 will be able to interfere with the disease course and improve both the local and systemic outcome of patients in the clinical setting.
Severe Intra-abdominal infections (IAI)
Severe IAI are one of the most common causes for hospitalization and when acquired within the hospital, they carry a high risk of mortality and morbidity. Abdominal infections could be a consequence of transmigration, perforation or anastomotic disruption involving the gastrointestinal tract. If left untreated abdominal infections will result in significant mortality. Infections can be either uncomplicated or complicated and cause either localized or diffuse peritonitis. Source control through surgical intervention and appropriate antibiotic therapy are the mainstay of the standard approach to treating intra abdominal infections. The incidence of severe abdominal infections in the US is 150,000/year, with a mortality rate from secondary peritonitis of 35%.
AB103 has been studied extensively in an animal model of polymicrobial abdominal infections demonstrating complete survival whereas standard of care alone (antibiotics treatment) was inadequate. Adding AB103 to antibiotics significantly extended the therapeutic time window beyond that of antibiotics alone (up to 24 hours post infection). Atox Bio anticipates that these results will translate into substantial treatment benefit in patients with severe intra abdominal infections.