The Phase IIb study focuses on demonstrating efficacy of nangibotide and provide clinically relevant proof in the treatment of septic shock
Paris based biotechnology company Inotrem S.A. has reportedly announced FDA clearance for the company’s investigational new drug application for the ASTONISH trial (Phase IIb) that is aimed at studying the safety, efficacy and tolerance of nangibotide (LR12) – it’s leading compound for septic shock.
According to trusted sources, the phase IIb study facilitates efficacy of nangibotide and will provide relevant proof in the treatment of septic shock among patients. Additionally, ASTONISH will be a global multicentric trial that will be conducted in the U.S. and Europe.
Supposedly, the study will validate a personalized medicinal approach using TREM-1, a potential diagnostic test that aides in identifying patients who are likely to benefit from nangibotide treatment.
For the record, FDA clearance was solely based on the review of the previously submitted information on preclinical and clinical findings with nangibotide, specially in the phase IIa clinical trial that depicts tolerability and safety of nangibotide in patients diagnosed with septic shock.
Apparently, preclinical models reviewed by the FDA depicted that nangibotide could restore inflammatory response, enhanced survival in septic shock animal models and vascular functions. The ASTONISH clinical trial design is formulated as per discussions with FDA during a preIND meeting.
Citing reports, septic shock is a condition involving complications of sepsis and currently has a highly unmet medical need. Developing countries have been witnessing rising cases of septic shock and about 35% mortality rate. Currently, there is no specified treatment approved for the indication apart from symptomatic and antibiotic treatment. The solution formulated by Inotrem follows a novel approach of immunomodulation that targets the TREM-1 pathway.
As per reliable sources, the IND is now effectively allowing the biopharma company to carry out Phase IIb study among septic shock patients in the U.S. However, the regulatory process for the clinical trial and its authorization is currently ongoing in Europe.