Atox Bio will conduct a Phase II study for a soft tissue infections treatment.
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Atox Bio, which develops therapeutics for severe infections, has raised up to $23 million in a Series E investment led by SR One with participation by Lundbeckfond Ventures and OrbiMed Israel.
The funds will enable Atox Bio to initiate a late stage clinical study of AB103, a novel therapy for the treatment of Necrotizing Soft Tissue Infections, commonly referred to as the “flesh eating bacteria” and other severe infections. The study is expected to start in the second half of 2015.
AB103, a novel immunomodulator discovered by Prof. Raymond Kaempfer and Dr. Gila Arad and licensed from Yissum Technology Transfer Company of the Hebrew University of Jerusalem is a short peptide that modulates the host’s inflammatory response through binding to the CD28 dimer interface. It offers a unique approach in the treatment of infectious diseases by modulating, but not inhibiting, the host immune system. This approach of targeting the host response rather than the pathogen precludes the rapid generation of drug resistance and provides a multisystem solution for bacterial infections with broad-spectrum coverage, independent of pathogen type.
AB103 successfully completed a Phase II study in patients with NSTI and the results demonstrated that patients treated with AB103 had a meaningful improvement across multiple end points. 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.
AB103 is the first product specifically developed for NSTI and has received Orphan Drug status and Fast Track designation from the FDA as well as a positive opinion from the EMA’s Committee for Orphan Medicinal Products (COMP).
NSTI are rare, fast progressing infections that result in significant tissue destruction and systemic disease leading to multiple organ dysfunction. Currently, there are no approved treatments for NSTI and the standard of care includes prompt and repeated surgical debridement, aggressive resuscitation and physiologic support, in addition to antibiotics.
Atox Bio CEO Dan Teleman said, “With this investment, we plan to advance AB103’s clinical development and further expand into new therapeutic categories.” OrbiMed Israel Managing Director Erez Chimovits said, “We found Atox Bio’s approach to modulating the immune response towards solving serious infections with significant unmet need to be unique and promising. AB103 may be applicable to treating patients suffering from a variety of indications for which no other therapies currently exist.”