Inotrem Receives Approval to Expand Nangibotide Clinical Trial in Critically Ill COVID-19 Patients and Receives Additional Public Funding of €45 Million
12.7.2021 10:00:00 EEST | Business Wire | Press release
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.
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210712005071/en/
Contact information
Media
Inotrem
Anne REIN - Strategies & Image (S&I)
anne.rein@strategiesimage.com
+33 6 03 35 92 05
Bpifrance
Sophie Santandrea
Sophie.santandrea@bpifrance.fr
+33 1 45 65 51 62
Secrétariat général pour l’investissement
presse.sgpi@pm.gouv.fr
+ 33 1 42 75 64 58
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Follow-on Order Brings Orders from INNIO Data Center Customer to 1.72 GW, Further Strengthening INNIO’s Data Center Backlog and Revenue Visibility22.10.2026 15:30:00 EEST | Press release
INNIO N.V. (Nasdaq: INIO) today announced a 620 megawatt (MW) follow-on order from a leading developer and operator of mega-scale data center campuses in the U.S. Together with the customer’s 1.1 gigawatt (GW) order announced in July 2026, the new order brings cumulative orders from the customer to approximately 1.72 GW, further strengthening INNIO’s order backlog and visibility into future revenues. “This follow-on order, coming just months after the customer’s initial 1.1 GW order, underscores the strength of customer demand and continued confidence in INNIO. Our containerized Jenbacher solutions deliver what data centers need most: fast deployment, high power density, fuel efficiency, and the performance to support demanding AI workloads,” said Dr. Olaf Berlien, President and CEO of INNIO. “Repeat orders of this scale, combined with long-term service agreements, strengthen our backlog and expand the services base that underpins our business model,” added Dr. Berlien. All 620 MW will
European Public Transport Budgets Require 36% Annual Spending Increase by 2035, Arthur D. Little and Polis Research Finds22.10.2026 15:30:00 EEST | Press release
Europe’s public transport sector currently accounts for €130 billion in annual expenditure, yet faces a growing funding gap as demand rises and environmental and resilience requirements intensify. New research from Arthur D. Little (ADL)’s Future of Mobility Lab and POLIS, a network of European cities and regions collaborating to develop innovative and sustainable urban transport solutions, outlines the scale of this financial shortfall and provides radical recommendations for overcoming it. Based on research with senior transport and policymakers, in-depth literature reviews, and real-world data from Paris, London, Amsterdam, Berlin and New York, the report estimates that additional spending will require a 36% increase in overall annual expenditure from now to 2035 onwards. This is made up of a 13% rise in operating expenditure (OPEX) and 56% in capital expenditure (CAPEX), driven by: Hidden debt caused by historic underinvestment in existing infrastructure (6% of additional funding n
Hitachi Report Examines Readiness for Physical AI in Industrial Companies22.10.2026 15:00:00 EEST | Press release
Hitachi, Ltd. (TSE:6501, "Hitachi") announced the release of its physical AI survey-based research report, Beyond the Pilot: Industry’s Physical AI Progression. The company surveyed over 200 global decision-makers from organizations operating in mission-critical industrial sectors including energy, manufacturing, transportation and logistics. The report explores how businesses today adopt AI in industrial use-cases, where they see the greatest value, and what it will take to scale toward physical AI deployments. Readers will gain practical insights on how to accelerate AI adoption while improving competitiveness, productivity, and long-term business performance. After successfully transforming knowledge work, AI is now entering the physical systems that form society’s backbone: energy, industrial, and mobility infrastructure, to name a few. Given these systems’ reliability, safety, and regulatory requirements, there is no room for AI hallucinations. In short, AI technology applied to t
Datavault AI Signs Non-Binding Letter of Intent to Acquire a 19.9% Equity Stake in DataMEDS AI in Consideration of an Expanded Technology License22.10.2026 15:00:00 EEST | Press release
Datavault AI Inc. (“Datavault AI” or the “Company”) (Nasdaq: DVLT), an Artificial Intelligence Platform (“AIP”) company providing data monetization, credentialing, and real-world asset (“RWA”) tokenization, today announced that it has entered into a non-binding letter of intent (“LOI”) to acquire a 19.9% equity interest in DataMEDS AI, Inc. (NASDAQ: MEDS) (“DataMEDS”) in consideration of an expansion of its existing technology license with DataMEDS. The proposed transaction is subject to completion of due diligence and negotiation of definitive agreements and will be subject to customary closing conditions for a transaction of this nature. The proposed transaction is structured to provide Datavault AI with the opportunity to obtain an equity interest in DataMEDS while preserving ownership of its underlying intellectual property. In exchange for expanding its existing technology license, Datavault AI expects to receive a 19.9% equity interest in DataMEDS on a fully diluted basis, with t
Megaport Expands AWS Connectivity With AWS Interconnect to Simplify How Customers Connect Their Infrastructure22.10.2026 15:00:00 EEST | Press release
Megaport Limited (ASX: MP1) (“Megaport”), a leading global automated infrastructure platform, today announced support for AWS Interconnect, a new managed connection model from Amazon Web Services (AWS) designed to simplify how businesses connect their infrastructure to AWS. AWS Interconnect from Megaport gives enterprises and AI infrastructure providers an automated connectivity option as their requirements grow beyond traditional AWS Hosted Connections. MACsec encryption and four redundant links across two sites will be included as part of the service at general availability, with customers able to select connection speeds from 1 Gbps to 100 Gbps. Customers can start an order for AWS Interconnect - last mile from either the Megaport Portal or AWS Management Console and complete it from the other. AWS and Megaport then automate the underlying network configuration, including VLANs, IP subnets, MTU, and BGP. This removes the need for customers to arrange the port, letter of authorizatio
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