Business Wire

INOTREM

12.7.2021 09:02:09 CEST | Business Wire | Press release

Share
Inotrem Receives Approval to Expand Nangibotide Clinical Trial in Critically Ill COVID-19 Patients and Receives Additional Public Funding of €45 Million

Inotrem S.A., a biotechnology company specializing in the development of immunotherapies targeting the TREM-1 pathway, announces that it has obtained authorization to pursue the clinical development of nangibotide up to registration in COVID-19 patients from both the French and Belgian competent authorities.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210712005071/en/

As part of this program, Inotrem receives additional 45 million euros in public funding under the "Capacity Building" Call for Expression of Interest, operated on behalf of the French government by Bpifrance, the French national investment bank, as part of the Programme d’investissements d’avenir (PIA) and the France Recovery Plan, bringing French state support for the project to a total of 52,5 million euros. This public funding will support Inotrem’s clinical program including the phase 2/3 study “ESSENTIAL” which aims to demonstrate the efficacy and safety of nangibotide in treating patients in respiratory distress with severe forms of COVID-19.

The primary endpoint is evaluation of the impact of nangibotide on the progression of disease in patients receiving ventilatory support due to COVID-19 as well as on the severity of the respiratory failure, duration of mechanical ventilation, length of stay in intensive care and mortality. In “ESSENTIAL”, a Phase 2/3 clinical program, up to 730 patients will be enrolled initially in France and Belgium and, possibly in other European countries. Pre-defined interim analyses will be conducted by an independent Data Monitoring Board to test futility and to allow for the study design to be adapted as necessary. “ESSNTIAL” is the continuation of a 60 patients phase 2a evaluating the safety and efficacy of nangibotide in patients suffering from severe COVID-19. In July 2020, the CoviTREM-1 consortium, which includes the Nancy and Limoges university hospitals and Inotrem, obtained public funding of 7,5 million euros under the “PSPC-COVID” call for projects, operated on behalf of the French government by Bpifrance

New pre-clinical studies with nangibotide have demonstrated that the administration of nangibotide in murine models infected with SARS-CoV-2 was associated with a decrease in inflammatory mediators and an improvement of clinical signs, in particular respiratory function, and survival. Inotrem also confirmed in 3 different and independent cohorts that sTREM-1, a marker of the activation of the TREM-1 biological pathway, is associated with both severity and mortality in critically ill COVID-19 patients.

Leveraging the results of these preclinical studies and the implications for the role of the TREM-1 pathway in COVID-19, Inotrem has filed additional patents to cover nangibotide use in severe forms of COVID-19 as well as the use of sTREM-1 as a biomarker and companion diagnostic. This significantly strengthens Inotrem’s already broad patent estate.

Jean-Jacques Garaud, Executive Vice-President, Head of Scientific and Medical Affairs and Inotrem’s co-founder said :“We are eager to pursue the development of nangibotide in these severe forms of COVID-19. Nangibotide is a TREM-1 inhibitor which has already demonstrated a trend towards efficacy in septic shock patients and has the potential to modulate the dysregulated immune response in critically ill COVID-19 patients. With this large clinical study, we can demonstrate efficacy for nangibotide in a further indication with the goals of reducing the duration of hospitalization and mortality.”

Sven Zimmerman, CEO of Inotrem, also declared : “The size of the financial support awarded to us as part of the French government’s initiative against COVID-19 is a testimony to the relevance of targeting the TREM-1 pathway with nangibotide in these severely ill patients. We are delighted by the confidence placed in our technology and our team. Everyone at Inotrem is fully committed to deliver on this ambitious program alongside nangibotide’s ongoing Phase 2b trial in septic shock patients.”

About Inotrem
Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, LR12 (nangibotide), with potential applications in a number of therapeutic indications such as septic shock and myocardial infarction. In parallel, Inotrem has also launched another program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European and North American investors.

www.inotrem.com

About TREM-1 pathway
TREM-1 pathway is an amplification loop of the immune response that triggers an exuberant and hyperactivated immune state which is known to play a crucial role in the pathophysiology of septic shock and acute myocardial infarction.

About Nangibotide
Nangibotide is the formulation of the active ingredient LR12, which is a 12 amino-acid peptide prepared by chemical synthesis. LR12 is a specific TREM-1 inhibitor, acting as a decoy receptor and interfering in the binding of TREM-1 and its ligand. In preclinical septic shock models, nangibotide was able to restore appropriate inflammatory response, vascular function, and improved animals’ survival post septic shock.

About ESSENTIAL study:
The Efficacy and Safety Study Exploring Nangibotide Treatment in COVID-19 pAtients with ventiLatory support, is a randomized, double-blind, placebo-controlled confirmatory study with adaptive features that will be performed in Europe. This is a pivotal study and it is expected that based on its results, nangibotide could be registered in this indication. The first part of the study (i.e.: 60 patients) has been already finalized and assessed by an independent data monitoring committee with excellent safety results. The study will recruit up to 730 patients in up to 40 sites. Several interim and futility analyses are foreseen as part of the adaptive design of the study.

About Bpifrance
Bpifrance is the French national investment bank: it finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extra-financial services (training, consultancy.). to help entrepreneurs meet their challenges (innovation, export…).
For more information, please visit: www.bpifrance.fr and presse.bpifrance.fr
Follow us on Twitter: @Bpifrance - @BpifrancePresse

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Vedanta FY26 Profit Soars by 22% to $2.8 bn; Enters Demerger Phase11.5.2026 02:30:00 CEST | Press release

India-based Vedanta Limited (BSE: 500295 & NSE: VEDL), a global leader in metals, oil & gas, critical minerals, power and technology, announced its results for the fourth quarter and full year ended 31 March 2026. It has delivered its best-ever financial performance, driven by structurally strong businesses and disciplined execution. For the full year, Vedanta’s Profit stood at an all-time high of $2.8 bn, reflecting a 22% YoY increase and a profit of $1 bn in Q4 FY26, up nearly 90% YoY. Vedanta reported its highest-ever annual revenue of about $20 bn, up 15% YoY, with Q4 revenue at $5.6 bn, an increase of nearly 30% YoY. The Company maintained strong cost leadership, contributing to record EBITDA of $6.3 bn for FY26, up by about 30% YoY, with margins expanding to around 40%. Q4 EBITDA stood at $2.0 bn, up by nearly 60% YoY, with a margin of approximately 44%. The balance sheet strengthened further, with Net Debt/EBITDA improving to 0.95x, supported by strong cash generation. Underscor

Andersen Global udvider sin afrikanske platform med tilføjelsen af medlemsfirma i Namibia9.5.2026 02:35:00 CEST | Pressemeddelelse

Andersen Global udbygger sin tilstedeværelse i Afrika med tilføjelsen af Andersen in Namibia, da Windhoek Advisory & Taxation tager Andersen-brandet til sig og styrker sine forudsætninger for at betjene virksomheder med aktiviteter i et af det sydlige Afrikas dynamiske vækstmarkeder. Andersen in Namibia har været et samarbejdsfirma siden 2021 og er en lokalt ejet revisions- og konsulentvirksomhed, der leverer ydelser inden for regnskab, skat og forretningsrådgivning, tilpasset de unikke behov i Namibias erhvervsklima. Med ekspertise inden for minedrift, landbrug, logistik, turisme og finansielle tjenesteydelser – sektorer, der er afgørende for Namibias økonomi – bistår firmaet både indenlandske virksomheder og internationale selskaber, der etablerer sig i regionen. Gennem cloudbaseret teknologi og datadrevet indsigt leverer Andersen i Namibia effektive og skalerbare løsninger, der gør det muligt for virksomheder at optimere deres drift, håndtere skatteforpligtelser på tværs af jurisdik

Andersen Consulting styrker sine kompetencer inden for organisatorisk transformation med Afiniti8.5.2026 20:45:00 CEST | Pressemeddelelse

Andersen Consulting annoncerer en samarbejdsaftale med Afiniti, et globalt konsulentfirma inden for forretningstransformation med hovedkontor i Storbritannien, der hjælper organisationer med at levere og opretholde komplekse forandringsprojekter. Afiniti blev stiftet i 2003 og er et globalt konsulenthus inden for forretningsforandring med base i Storbritannien og USA. De støtter klienter gennem komplekse transformationer på tværs af mennesker, processer, systemer og data, og de skaber mærkbare forandringer gennem kreative konsulentydelser. Virksomheden betjener primært stærkt regulerede, sikkerhedsdrevne og aktivtunge organisationer med store, geografisk spredte arbejdsstyrker inden for sektorer som energi, forsyning, biovidenskab, transport og byggeri. Afiniti samarbejder med velkendte brands om at levere ekspertise fra start til slut på tværs af organisatoriske, digitale og ai-baserede transformationer samt ændringer i kultur og driftsmodeller. Dette gælder især komplekse scenarier s

Verdantis Launches MRO360 “The World's First AI-Native Spare Parts Intelligence Platform”8.5.2026 15:40:00 CEST | Press release

MRO360 is the first milestone in Verdantis's journey to deliver the industry's first fully AI-native Enterprise Asset Management solution. Verdantis today announced the global launch of MRO360, a purpose-built AI platform that transforms how asset-intensive organizations manage their MRO spare parts inventory. Designed for manufacturers, oil and gas operators, mining companies, utilities, and other industrial enterprises, MRO360 deploys nine interconnected AI agents that continuously forecast demand, score parts criticality, manage obsolescence risk, calculate dynamic reorder points, helps intercompany plant transfer thereby realizing the exact dollar value of every optimization opportunity across a spare parts catalog in real time. Unlike traditional EAM and CMMS platforms built on static rules, MRO360's agents adapt continuously as demand patterns, supplier performance, and equipment health evolve. For the first time, a maintenance planner can see which work orders are at supply risk

Cyble Positioned as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies8.5.2026 15:22:00 CEST | Press release

Cyble today announced it has been recognized as a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies. The company believes this recognition underscores Cyble’s mission to make threat intelligence truly operational—delivering AI-native capabilities that enable enterprises, government agencies, and MSSPs to shift from reactive security to proactive, intelligence-driven defense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260508164528/en/ Cyble Named a Challenger in the 2026 Gartner® Magic Quadrant™ for Cyberthreat Intelligence Technologies "Security teams are under constant pressure to respond faster with greater accuracy," said Beenu Arora, Co-Founder and CEO, Cyble. "We believe this recognition highlights our focus on delivering intelligence that drives real outcomes—cutting through noise, accelerating response, and enabling confident decision-making at scale." Intelligence That Acts

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye