Inotrem Announces Enrollment of First Patient in its Phase IIb ASTONISH Trial for Nangibotide in the Treatment of Septic Shock
21.11.2019 10:00:00 EET | Business Wire | Press release
Inotrem S.A., a biotechnology company specializing in immunotherapy for acute inflammatory syndromes, through its knowledge of the TREM-1 pathway biology, announced today it has initiated its Phase IIb ASTONISH trial to evaluate nangibotide in the treatment of septic shock and has enrolled the first patient in the trial.
Nangibotide is a TREM-1 inhibitor peptide with the potential to restore appropriate inflammatory response, vascular function, and improve post septic shock survival. Septic shock is the ultimate complication of sepsis. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. There is currently no specific therapy approved for this indication besides antibiotics and supportive treatment. Inotrem’s therapeutic solution has the potential to become the first mechanism-based treatment for septic shock. Nangibotide in septic shock has been granted the fast track status in September 2019 by the FDA and the PRIME status in 2017 by the EMA.
The Phase IIb ASTONISH study aims to demonstrate the efficacy of nangibotide and bring a medically relevant proof of clinical activity in septic shock patients. In addition, this global multicentric study intends to validate a personalized medicine approach using soluble TREM-1 as potential companion diagnostic test to identify patients more likely to benefit from nangibotide treatment. The study will be conducted in 48 clinical sites across 5 European countries and the United States and will enroll a total number of 450 patients.
Jean-Jacques Garaud, CEO of Inotrem, said: “The ASTONISH trial is a Phase III enabling trial and we expect that it will generate important insights about nangibotide’s clinical activity and our personalized medicine approach in septic shock. We are enthusiastic about this study and Inotrem’s capacity to bring a first in class product in an area with major unmet medical need and to patients who today have no access to any approved treatment”.
With nangibotide, Inotrem has developed a novel approach of immunomodulation targeting the TREM-1 pathway which has the potential to address, beyond septic shock, several others acute inflammatory syndromes for which there is a major and today unsatisfied therapeutic need. Based on its its extensive knowledge of the TREM-1 pathway biology, Inotrem has aso launched a new program to expand its TREM-1 franchise into chronic inflammatory diseases
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. 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 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. Nangibotide in septic shock has been granted the fast track status in September 2019 by the FDA.
ASTONISH Study
The Efficacy, Safety and Tolerability of nangibotide in Patients with Septic Shock (ASTONISH) phase IIb trial is a Randomized, Double-blind, Placebo Controlled Dose Selection Study that will be performed Europe and the US. Four hundred and fifty patients are planned to be included in this study in 48 clinical sites. The study will compare the effect of nangibotide at two different doses versus standard of care.
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/20191120005756/en/
Contact information
Media contact for Inotrem
Anne REIN
S&I
anne.rein@strategiesimage.com
+33 6 03 35 92 05
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
SES Launches Cash Tender Offer28.9.2026 14:21:00 EEST | Press release
THIS ANNOUNCEMENT RELATES TO THE DISCLOSURE OF INFORMATION THAT QUALIFIED OR MAY HAVE QUALIFIED AS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE MARKET ABUSE REGULATION (EU) 596/2014. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO OR TO ANY PERSON LOCATED OR RESIDENT IN, OR AT ANY ADDRESS IN, THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS (INCLUDING PUERTO RICO, THE U.S. VIRGIN ISLANDS, GUAM, AMERICAN SAMOA, WAKE ISLAND AND THE NORTHERN MARIANA ISLANDS), ANY STATE OF THE UNITED STATES OF AMERICA OR THE DISTRICT OF COLUMBIA (THE UNITED STATES) OR TO ANY U.S. PERSON (AS DEFINED IN REGULATION S OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT)) OR IN OR INTO ANY JURISDICTION WHERE IT IS UNLAWFUL TO RELEASE, PUBLISH OR DISTRIBUTE THIS ANNOUNCEMENT (SEE “OFFER AND DISTRIBUTION RESTRICTIONS” BELOW). SES (the “Offeror”) announces today that it is inviting holders of its outstanding €500,000,000 0.875 per cent. Guaranteed Notes
Horizon3 Earns Cyber Essentials Certification Covering NodeZero EU Network28.9.2026 11:00:00 EEST | Press release
Horizon3, the AI-Native Proactive Security Company, today announced that it has earned Cyber Essentials Plus certification covering its NodeZero AWS EU network. The network supports Horizon3’s EU data sovereignty site in Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928143792/en/ Horizon3 Earns Cyber Essentials Certification Covering NodeZero EU Network Organizations use NodeZero® to test production environments and find weaknesses attackers can exploit. When customers and partners assess the platform itself, they also need to understand the security standards applied to its supporting infrastructure. The Cyber Essentials certificate identifies a defined portion of that infrastructure and the baseline against which it was assessed. Developed by the UK’s National Cyber Security Centre, Cyber Essentials addresses five foundational controls: firewalls, secure configuration, security updates, user access control, an
Thales Expands Collaboration with Google Cloud to Help Secure Agentic AI Workflows28.9.2026 10:03:00 EEST | Press release
Thales today announced an expanded collaboration with Google Cloud to help enterprises address emerging security and governance challenges associated with agentic AI, bringing integrated protection, visibility, and policy enforcement to AI-driven workflows on Google Cloud. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260928647188/en/ ©Thales The integration of Thales AI Security Fabric with Google Cloud Gemini Enterprise helps organizations apply security, governance, and visibility across interactions among users, agents, models, and tools in real time. “Enterprises are moving from AI assistants to AI agents that can autonomously take action, make decisions, and interact with critical business systems. This requires a fundamentally different approach to security,” Eva Rudin, Senior Vice President, Cybersecurity Products, at Thales, said.“By expanding our collaboration with Google Cloud, we are helping organizations build
SPORVIGILANCE Targets Safer Medicines and Billion-Euro Savings for Global Pharma Facing EU IDMP Fines28.9.2026 09:13:00 EEST | Press release
British regulatory technology company SPORVIGILANCE is targeting one of global pharma’s major compliance challenges with a platform offering a faster route to IDMP and SPOR readiness, compliance and governance. As the European Medicines Agency advances structured medicinal product data, companies face pressure to keep regulatory data accurate, standardised and aligned with EMA requirements. SPORVIGILANCE replaces fragmented manual assessment with a regulatory intelligence layer built around IDMP, SPOR and Product Management Service (PMS) requirements. At its core is an IDMP Business Rule Validation Engine that assesses medicinal product data at scale and at field level, identifying missing, inconsistent and non-compliant data. SPORVIGILANCE is the only platform to translate IDMP business rules directly into automated validation logic, enabling companies to test data against the rules rather than rely on manual interpretation. Its PMS Alignment capability reconciles internal RIM data ag
Sofinnova Partners Closes Oversubscribed €82 Million Sofinnova MD Start IV Fund to Create the Next Generation of Medtech Companies28.9.2026 09:00:00 EEST | Press release
Sofinnova Partners ("Sofinnova"), a leading European life sciences venture capital firm based in Paris, London, and Milan, today announced the final close of Sofinnova MD Start IV at €82 million. The fund, which was oversubscribed, will help expand Sofinnova's medtech company-creation strategy across Europe and the US with greater capacity to launch new ventures and support them through key stages of development. With plans to launch six to eight new medtech companies over the next five years, Sofinnova MD Start IV will support ventures from inception through key clinical and operational milestones, providing founders with both capital and hands-on support. Sofinnova MD Start's approach combines clinical insight, entrepreneurial talent, and operational expertise to tackle significant unmet medical needs. The previous fund, Sofinnova MD Start III, a €63 million fund, invested across six companies that have collectively raised more than €140 million in follow-on financing. Sofinnova MD S
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