Israeli biotechnology company Atox Bio is taking on flesh-eating bacteria.
Its drug, called Reltecimod, is in a Phase 3 clinical trial to fight the bacterial infection that results in the death of the body’s soft tissue, including skin, fat, tendons and ligaments. The infection is rare in healthy people, but when it takes hold it progresses very quickly.
Typically the bacteria can enter the body through a simple cut, a scrape, or surgical wound. The initial symptoms of the illness can include red, swollen skin, fever, shivering, nausea, vomiting and diarrhea. These lead to pain and then perhaps oozing from the infected area, with blisters, bumps or other skin lesions appearing.
“In flesh-eating bacteria, the main danger is that the body’s immune system ‘overreacts’ and causes significant tissue destruction and sometimes also systemic disease, leading to multiple organ dysfunction, failure and even death,” said Dan Teleman, the CEO of Atox, in an email interview.
The drug developed by the Ness Ziona, Israel- and Chapel Hill, North Carolina-based company, is a peptide — a small protein — that binds to a protein expressed by the T-cells, a type of blood cells that play a central role in the body’s immune system, and enables to restore the patient’s appropriate immune response to severe infections.
By changing, “but not inhibiting, the body’s acute inflammatory response, Reltecimod is designed to help control the cytokine storm that could otherwise quickly lead to morbidity and mortality,” he said. Cytokines are the small proteins released by the immune system that signal an infection.
Reltecimod received Orphan Drug status from the US Food & Drug Administration and the European Medicines Agency, as well as Fast Track designation — all of which are intended to enable the quicker development of the drug.
Currently, explained Teleman, “there are no therapies available for this serious, life threatening condition.” To fight the infection, surgery is often used “for the removal of the destructed tissue, which can sometimes lead to amputation, and antibiotics. The problem with antibiotics is that it takes some time until they start working, and in the meantime the flesh eating bacteria continues to spread in the body.”
Atox Bio’s product targets not the bacteria but the immune response of the patient, which is the main reason for morbidity, he explained.
The ongoing Phase 3 trial is designed to assess the efficacy and safety of Reltecimod versus a placebo in patients with necrotizing soft tissue infections (NSTI), or the medical term for flesh eating bacteria. The study is being conducted at 60 trauma sites across the US, and will recruit a total of 290 patients. Results of the Phase 3 study are expected during 2019, the company said.
A Phase 2 study of the drug, conducted at seven trauma sites in the US — in which patients received a single dose of either Reltecimod or placebo administered within six hours of clinical diagnosis, showed a “statistically significant effect in the resolution of organ failure,” Teleman said.
If the Phase 3 trial goes well, he said, the drug could be available as soon as the end of 2020.
Earlier this month Atox said it raised $30 million, with investors including Arix Bioscience plc, which led the round, Adams Street Partners, Asahi Kasei Corporation and other undisclosed investors.
The proceeds will be used to further develop Reltecimod to tackle acute kidney injury (AKI) – a condition that to date has no cure and leaves critically ill patients with severe infections and possibly permanent reduction in kidney function. The disease, for which the only treatment options are dialysis and supportive care, is also associated with an increased risk of death, prolonged hospitalization, and increased medical costs. AKI affects annually around 3 million patients in the US, Europe and Japan, the company estimated.
“The company plans to initiate a Phase 2 clinical study in this second indication during 2018, and results of the Phase 2 are expected in 2019,” said Teleman.
Atox was founded in 2003, based on the research of Prof. Raymond Kaempfer and Dr. Gila Arad from the Hebrew University of Jerusalem. The firm has raised a total of $60 million in private funding to date, including from the latest funding round.
Existing investors SR One, OrbiMed, Lundbeckfonden Ventures, Becker and Integra Holdings also participated in the latest financing round.