Inotrem gets clearance to launch phase 2 trial of Nangibotide in Covid-19 patients

Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway, announced that it has obtained authorization to launch its phase IIa clinical trial in COVID-19 patients in France, Belgium and the USA.

For this study, Inotrem received a non-dilutive funding as part of the call for proposals PSPC Covid, financed by the Investments d’Avenir Program which managed on behalf of the French government by Bpifrance, France’s public investment bank. Inotrem with its partners the CHRU of Nancy and the CHU of Limoges, was one of the 6 French biotech companies who benefited from this programme to support the research and development of therapeutic solutions targeting COVID-19.

The goal of this first exploratory study is to determine the safety and tolerability and potential signals of efficacy of nangibotide in critically ill patients with COVID-19 with features of systemic inflammation. The objective of this project is to have a positive impact on the severity of the respiratory failure, reduce duration of mechanical ventilation, length of stay in ICU and reduce mortality. Sixty patients will be enrolled in Europe and in the United States. This study follows an observational study in 27 patients, conducted by Prof. Sébastien Gibot at the CHRU of Nancy, which showed an increased expression of the TREM-1 pathway in severe COVID-19 patients. TREM-1 is an immunomodulatory receptor expressed on innate immune cells which amplifies and maintains inflammation.

Previous clinical studies with nangibotide demonstrated its safety and tolerability in patients suffering from septic shock, which is also characterized by a systemic inflammatory reaction. Pre-clinical models have shown that nangibotide inhibits the amplification of the immune response caused by the activation of TREM-1 and was able to restore appropriate inflammatory response, vascular function, and improved survival in septic shock models. Inotrem is currently conducting a Phase IIb trial (ASTONISH) to treat septic shock patients with nangibotide in 6 European countries and in the United States. It is also developing, with Roche Diagnostics, a companion diagnostic test to identify septic schock patients more likely to benefit from its nangibotide treatment.

Coronavirus disease 2019 is a new pandemic disease that arises as a consequence of infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The optimum treatment strategy in the management of critically ill patients with COVID-19 continues to evolve and, in addition to supportive therapies such as mechanical ventilation, vasopressors and renal replacement therapy, may include immunomodulatory approaches, such as nangibotide, in patients with severe disease.

Professor Sébastien Gibot, Nancy University Hospital and coordinating investigator said “We observed that the TREM-1 pathway was activated in severe forms of COVID-19. Nangibotide is a TREM-1 inhibitor and has the potential to restore an appropriate immune response. We are hoping to demonstrate that nangibotide will reduce the duration of hospitalization and mortality of critically ill patients suffering from COVID-19”.

Jean-Jacques Garaud, CEO of Inotrem, declared: “We are very pleased with both the granting of this financial support and the clearance to start our clinical trial. The French administration has been very effective in working in a coordinated and rapid fashion.”