Inotrem announces Data Monitoring Committee (DMC) recommends continuation of Phase IIa study of nangibotide for the treatment of severe forms of COVID-19
Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway, announces today that an independent Data Monitoring Committee (DMC) recommends continuation of the Phase IIa study of nangibotide for the treatment of severe forms of COVID-19 hospitalized in intensive care units (ICU). The DMC was composed of unblinded external medical experts and based its decision on a pre-planned interim analysis of safety. This positive decision will allow Inotrem and its partners, the CHRU of Nancy and the CHU of Limoges, to carry on without modification its Phase IIa trial.
The first interim analysis was based on the first 20 patients enrolled. Inotrem expects to complete patients’ enrollment in France, Belgium, and the United States no later than the end the first quarter of 2021. The goal of this study is to determine the safety, tolerability and potential signals of efficacy of nangibotide in critically ill patients with COVID-19. Nangibotide is expected 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.
This study follows an observational study in 27 patients, conducted by Prof. Sébastien Gibot at the CHRU of Nancy, which reported 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.
In parallel, Inotrem is also currently conducting a Phase IIb trial (ASTONISH) to treat septic shock patients with nangibotide in six European countries and in the United States. Previous clinical studies with nangibotide in septic shock demonstrated that it was safe, well tolerated and showed signals towards clinically relevant efficacy. Pre-clinical models have shown that nangibotide modulates the amplification of the immune response caused by the activation of TREM-1 and is able to restore appropriate inflammatory response and vascular function, resulting in improved survival in septic shock models.
To conduct the Phase IIa COVID-19 trial, Inotrem and its partners received a non-dilutive funding by the Investments d’Avenir Program which is managed on behalf of the French government by Bpifrance, France’s public investment bank.
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.
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.
Media contact for Inotrem
Strategies & Image (S&I)
+33 6 03 35 92 05
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Verimatrix Releases Advanced Code Protection Service for Android Application Bundles20.1.2021 17:45:00 CET | Press release
Regulatory News: Verimatrix, (Paris:VMX), the leader in powering the modern connected world with people-centered security, today announced general availability of version 2.2 of the Verimatrix Application Protection service for Android. The company’s latest Code Protection service for Android applications now supports the forthcoming Android ecosystem change that will mandate the use of Android Application Bundles (AABs) in the second half of 2021. A significant shift for developers, the upcoming AAB mandate creates a need for simple, reliable software security that prevents app attacks. In addition to traditional APKs, the Verimatrix Application Protection service now also supports AABs defined by Google Play’s publishing guidelines. Other new features and in enhancements in Verimatrix Application Protection service for Android include: AAB support through the Verimatrix App Shield service or on-premise tool Upgraded whole app integrity verification based on certificate binding for pu
LG CHEM TO SEEK INNOVATIVE IDEAS FOR SUSTAINABLE TECHNOLOGIES WORLDWIDE THROUGH 3 rd GLOBAL INNOVATION CONTEST20.1.2021 15:00:00 CET | Press release
LG Chem (KRX: 051910) announced on 20th January that it will host the 3rd Global Innovation Contest (GIC) for leading universities and research institutions worldwide. Being the first of its kind in the Korean chemical industry, Global Innovation Contest invites organizations around the world to discover innovative ideas for sustainable technologies. The contest is open for entry from 25th January to 31st March in 4 categories: Energy, Sustainability, Advanced Materials, and Digital Transformation (DX). Under the new vision of the company “We connect science to life for a better future,” Sustainability and DX are 2 categories newly added this year. All scholars and researchers interested in developing the next generation’s innovative technology and industry-academia collaboration research are welcome to participate and submit their research proposals through the official GIC website. (www.rnd.lgchem.com/global/gic) LG Chem will form a judging panel of internal experts to evaluate the r
H.I.G. Capital Sells RGIB's Bathroom Furniture Division to Roca20.1.2021 14:20:00 CET | Press release
H.I.G. Capital, ("H.I.G."), a leading global private equity investment firm with over €35 billion of equity capital under management, and the Royo family have entered into an agreement to sell the bathroom furniture division of RG International Bathroom (“RGIB or the “Company”) to Roca Sanitario, S.A. The Royo family will retain a minority stake in the division. Both H.I.G. and the Royo family will continue as shareholders of the shower tray business of RGIB, operating under the Fiora brand. H.I.G. partnered with the Royo family in December 2016 and has achieved a number of important milestones, including: Developing a new factory and brand in Poland (Maximus) that contributed to strengthening the leading position that RGIB already had in the Polish market under the Elita brand Entering new segments, channels and countries; one of the most relevant achievements was the entry into the DIY channel in Germany where RGIB is now a leading player Consolidating RGIB’s leading position in Spai
Thales NS50 Radar to Equip the Belgium Navy and the Royal Netherlands Navy Next Generation Mine Counter Measures Vessels (MCMV)20.1.2021 10:00:00 CET | Press release
The navies of Belgium and the Netherlands rely on Thales, Naval Group and KERSHIP shipyard to equip the 12 next generation Mine Counter Measures Vessels with NS50 radars for Air & Surface Surveillance with Fire Control capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210120005024/en/ NS50 radar © Thales The NS50 provides for the first time a complete and superior level of self-protection capability against air and surface threats for this category of high value MCM vessels. A strategic choice for small to medium vessels, the NS50 offers dual functions between air and surface surveillance and fire control. The nature of threats faced by Navies has never been more varied nor more challenging, ranging from next generation anti-ship missiles, robotic warfare and swarm attacks, to electronic warfare (jamming) as well as, overall, having to operate in a simultaneously conventional, asymmetric and hybrid threat environm
SmartStream Reveal Their Latest API Suite With a Complete Range of Reference Data Services20.1.2021 10:00:00 CET | Press release
SmartStream Technologies, the financial Reference Data Utility (RDU) solutions provider, today announces the launch of its Application Programming Interface (API) suite – for quicker access to services providing accurate data, with improved customer service, operational efficiency, greater agility and competitiveness. The new fully comprehensive API service will benefit financial institutions by saving huge amounts on infrastructure costs, as well as an affordable service which is straightforward to deploy. Financial institutions are now realising the need for change, with many currently engaging in digital transformation projects including the implementation of APIs. RDU services currently fall into two categories: security reference data and regulatory reference data. Security reference data solutions available on an API basis will include a listed derivatives service, with data sourced from over 100 exchanges and comprehensive coverage for options, futures, options on futures and ca
Wiztopic and Euronext Corporate Services Sign a Commercial Partnership20.1.2021 08:00:00 CET | Press release
Wiztopic, the cloud-based provider of software solutions for corporate communications, public relations and investor relations professionals, today announced a commercial partnership with Euronext Corporate Services, a subsidiary of Euronext, providing companies with innovative solutions and tailor-made advisory services in the areas of governance, compliance, communication, and investor relations. This strategic alliance will simplify the access to highly complementary solutions for their respective customers. The combination of Euronext Corporate Services and Wiztopic’s solutions constitutes a suite of best-in-class digital communication solutions to satisfy the increasingly sophisticated needs of time-poor corporate communication, PR and IR professionals. Euronext Corporate Services’ clients will benefit from Wiztrust’s blockchain certification platform to secure their financial communications and avoid fake news. "This partnership solidifies Wiztrust as the European platform for ce
ENHERTU ® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer20.1.2021 08:00:00 CET | Press release
Daiichi Sankyo Company, Limited(hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. In Europe, approximately 531,000 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2 positive.1,2,3 The impact of the disease is significant, with breast cancer responsible for more than 141,000 deaths per year in Europe.1 “One in five women with breast cancer have HER2 positive disease and those with previously-treated metastatic disease often progress quickly,” said Professor Fabrice André, Head of Research, Department of Medical Oncology, Gustave Roussy Cancer Campus, Villejuif, France. “One of the biggest challenges in this setting has been identifying treatment strategies that produce a