A cure for flesh-eating bacteria is in the sights of BARDA, the US Health and Human Service’s Biomedical Advanced Research and Development Authority, and it has awarded Israeli biotech start-up Atox Bio a contract worth up to $24 million to develop treatments for Necrotizing Soft Tissue Infections (NSTI) , the formal name for the bacteria that, zombie-like, “eat” their way through human tissue.
NSTI is relatively rare, and it’s not that specific affliction that BARDA is worried about, the two new partners said. Besides NSTI, Atox Bio said, BARDA wants the company to develop treatments that would be also be applicable to “other biothreats and public health threats that end in sepsis,” in which a chemical or biological agent triggers an inflammatory response throughout the body that can damage multiple organ systems, causing them to fail. Among the bacteria that can cause sepsis: Anthrax, which has already been used in several terror attacks.
According to doctors, NSTI bacteria do not “eat” human flesh; instead, they chew it up and spit it out, releasing toxins that destroy the tissue that makes up skin and muscle. The effect, though, is the same – the flesh drops off or is eaten by other bacteria, and what is left is ripe for infection, gangrene, or a host of other maladies. Left untreated, nearly three quarters of NSTI sufferers die – and the only treatment available now is surgically removing the infected areas to prevent the bacteria from spreading, cancer-like, to the rest of the body.
Needless to say, that treatment is extremely difficult and painful, and it’s not always effective or even practical. NSTI can penetrate deep into skin and muscle, making it very difficult to totally remove the infection – and even if all the infected areas are treated with debridement (the technical term for flesh removal as applied to NSTI), there is always the possibility that some got left behind, starting the whole process over again.
Antibiotics help to some extent, but the bacteria fight back furiously, triggering an even more intense response by the body – often a severe inflammatory response, triggered by toxins and bacterial components that can end in tissue necrosis and organ failure. The response may “win the battle” by beating back the bacteria, at least temporarily – but the response can cause the body to “lose the war,” by destroying major physiological systems.
Ness Ziona-based Atox Bio has been doing research on an NSTI treatment that does not require cutting away massive amounts of tissue — a drug called AB103, which approaches the NSTI issue in a unique way. Instead of attacking the germ and precipitating a counter-attack the body will not be able to handle, it modulates the patient’s immune system – raising and lowering the body’s response to NSTI, using specially-designed short peptides, eight to 12 amino acids in length.
This approach, Atox Bio researchers have found, is much more effective in preventing the spread of the disease, and even beating it back. AB103 this year successfully completed a Phase 2 study, and patients showed “a meaningful improvement across multiple end points,” Atox Bio said. Patients treated with AB103 had a faster resolution of organ dysfunction, spent fewer days in the intensive care unit, required fewer days of assisted ventilation and needed fewer surgical procedures to remove infected tissue, the company said.
After several studies, AB103, which is based on technology licensed from Yissum, the technology transfer company of the Hebrew University of Jerusalem, was granted Orphan Drug status by the FDA and in the European Union, a designation given to drugs that treat rare diseases that most commercial drug firms do not develop treatments for. AB103 was discovered by Prof. Raymond Kaempfer and Dr. Gila Arad of the Hebrew University.
And now, BARDA has awarded Atox Bio an initial $4.4 million contract over the next 18 months to develop its technology. The contract also specifies several option periods which, if exercised by BARDA, would bring the total value of the award to $24 million. The contract covers manufacturing activities, regulatory activities and a pivotal clinical trial of AB103 in patients with NSTI.
Dan Teleman, CEO of Atox Bio, stated, “We are honored that BARDA has recognized the potential of AB103, a novel host-oriented therapeutic, to offer a new approach to treating severe infections where there are currently no approved therapies. We look forward to working with BARDA to advance the development of AB103 in NSTI and exploring its potential in bioterror pathogens.”