Date: 2015-12-07
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Atox Bio (Israel)
Product: AB103
Action
mechanism: immunomodulating agent/peptide. AB103, a novel immunomodulator, 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 has received orphan drug status from the FDA and EMA as well as Fast Track designation. Development of AB103 is being supported by a contract with the Biomedical Advanced Research and Development Authority (BARDA).
Disease: necrotizing soft tissue infections
Therapeutic area: Infectious diseases
Country: USA
Trial
details: The purpose of this phase 3, randomized, double-blind, placebo-controlled, paralle group, study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections receiving standard of care therapy. (NCT02469857 )
Latest
news: * On December 7, 2015, Atox Bio, developer of immunomodulatory therapeutics for rapidly-progressing infectious diseases in critically ill patients, announced that it has enrolled the first patient in its Phase 3 study to evaluate AB103 developed for the treatment of necrotizing soft tissue infections (NSTIs), also known as ‘flesh eating bacteria’. The ACCUTE (AB103 Clinical Composite endpoint StUdy in necrotizing soft Tissue InfEctions) study is conducted at
approximately 40 centers in the U.S. and expects to enroll 290 patients who will receive around the clock coverage by highly experienced surgical teams and critical care support.
The previously conducted Phase 2 study demonstrated that patients treated with AB103 showed consistent and meaningful improvements. Results from the study were published in JAMA Surgery. In addition, the company has conducted a comprehensive retrospective study of NSTI that helped inform the design of the Phase 3 trial.
Patients in the Phase 3 trial will receive AB103 or placebo, administered as a single dose during or shortly after initial surgical debridement, in addition to standard of care treatment. The primary endpoint is a clinical composite based on local and systemic components of this disease. Secondary endpoints include: time to resolution of organ dysfunction, recovery from acute kidney injury and health economic outcomes such as days on ventilation, days in the ICU and duration of hospital stay.
