Business Wire

Inotrem Announces FDA Clearance of Investigational New Drug (IND) for the Phase IIB ASTONISH Trial in Septic Shock Patients to Demonstrate Nangibotide Efficacy

Share

Inotrem S.A., a biotechnology company specialized in immunotherapy for acute inflammatory syndromes, announced today the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for the ASTONISH trial (Phase IIb) where the safety, tolerance and efficacy of nangibotide (LR12), its lead compound for septic shock, will be studied. The IND is now effective allowing Inotrem to begin its planned Phase IIb study in septic shock patients in the US.

The Phase IIb study will aim at demonstrating efficacy of nangibotide and bring a clinically relevant proof of clinical activity in septic shock patients. It will be a global multicentric study conducted in the United States and Europe. In addition, this 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 FDA decision was based on the review of the information provided on the previous preclinical and clinical experience with nangibotide in particular the Phase IIa clinical study which demonstrated the safety and tolerability of nangibotide in patients suffering from septic shock. Preclinical models reviewed by the FDA showed that nangibotide was able to restore appropriate inflammatory response, vascular function, and improved survival in septic shock animal models. The design of the ASTONISH clinical trial has been previously discussed with the FDA during a preIND meeting. The regulatory process for clinical trial authorization in European countries is currently ongoing.

Septic shock is the ultimate complication of sepsis and currently constitutes a high unmet medical need. 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 symptomatic treatment. Inotrem’s solution is based on a novel approach of immunomodulation which targets the TREM-1 pathway: a crucial mediator of the septic shock and has the potential to become the first mechanism-based treatment for septic shock.

Jean-Jacques Garaud, CEO of Inotrem, said: “The FDA’s clearance of IND for nangibotide is an important milestone for Inotrem. It confirms the strong potential of this novel therapeutic approach and gives us the opportunity to validate both the proof of clinical activity of nangibotide and our personalized medicine strategy in septic shock, a severe and often fatal condition for which there is currently no specific targeted therapies”.

Mitchell Levy, Division Chief of Pulmonary, Critical Care and Sleep Medicine at the Warren Alpert School of Medicine at Brown University and Medical Director, Medical Intensive Care Unit at Rhode Island Hospital and Inotrem’s main investigator in the United States, added: “We are thrilled by the FDA’s decision which will allow to begin Inotrem’s planned Phase IIb study in septic shock patients, and which as such recognizes the company’s unique position around the TREM-1 pathway”.

About Inotrem
Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute inflammatory syndromes, such as septic shock. 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 investors — Sofinnova Partners, Andera Partners, Biomed Invest and Inserm Transfert Initiative.
www.inotrem.com

About sTREM-1 and TREM-1 pathway.
TREM-1 pathway is an amplification loop of the immune response that triggers an exhuberant and hyperactivated immune state which is known to play a crucial role in the pathophysiology of septic shock and acute myocardial infarction. Today, there is an increasing number of publications indicating that the TREM-1 pathway is also implicated in chronic inflammatory diseases. Soluble TREM-1 (sTREM-1) is a plasma circulating protein which is released upon TREM-1 activation, and is thus a marker of TREM-1 pathway activation.

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 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.

Contact information

Media
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

IFF to Present at Barclays Global Consumer Staples Conference September 520.8.2019 23:15:00 EESTPress release

Regulatory News: IFF (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of taste, scent, and nutrition & ingredients today announced that the Company’s management will speak at the Barclays Global Consumer Staples Conference in Boston, Massachusetts, on Thursday, Sept 5, 2019 at 2:15 PM ET. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Welcome to IFF At IFF (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), we’re using Uncommon Sense to create what the world needs. As a collective of unconventional thinkers and creators, we put science and artistry to work to create unique and unexpected scents, tastes, experiences and ingredients for the products our world craves. Learn more at iff.com, Twitter , Facebook, Instagram, and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/ho

Novalis LifeSciences Launches its First Life Science Investment Fund with $85 Million20.8.2019 19:29:00 EESTPress release

August 20th, 2019, Novalis LifeSciences, an investment and advisory firm for the Life Science industry, announced today that it has raised $85M in capital for its first fund - Novalis LifeSciences Investments I, L.P. Novalis LifeSciences is focused on highly innovative Life Science companies. On the occasion of closing the first fund, Marijn E. Dekkers, founder and chairman, said: “This first fund is a growth-oriented fund that will invest in 8-12 companies that are commercializing breakthrough technologies in various segments of the Life Science industry. This includes drug discovery, life science tools, genomics, synthetic biology, diagnostics, and agricultural biotechnology – all areas with huge unmet needs and exciting opportunities for investors”. About Novalis LifeSciences Novalis Lifesciences LLC, is a globally acting venture capital firm focused on breakthrough technologies in Life Science. Founded and managed by Dr. Marijn E. Dekkers, current chairman of Unilever and former ch

Bermuda Tech Week 2019 to Celebrate Innovation and Explore Opportunities for Growth20.8.2019 17:27:00 EESTPress release

Registration is under way and filling fast for Bermuda Tech Week 2019 which will take place at the Hamilton Princess & Beach Club from October 14-18, 2019. The programme of insightful and engaging events will explore future opportunities and challenges presented by emerging technologies such as artificial intelligence, blockchain, digital assets, insurtech and virtual reality. It will showcase Bermuda’s ongoing success in creating a welcoming, stable and well-regulated environment where technology and start-up companies can thrive. “Bermuda has a long history of innovation so we understand and recognise the power of technology to positively impact both the economy and society,” said Bermuda Premier David Burt. “Over the past two years, we have built on our strength as a global leader in regulating the risks associated with the global insurance industry to develop a clear regulatory framework around managing the risks associated with Fintech. Our progressive approach has drawn accolades

Limelight Networks Expands Developer Toolkit With New API and Portal Enhancements20.8.2019 17:25:00 EESTPress release

Limelight Networks, Inc. (Nasdaq: LLNW), a leading provider of edge cloud services, today announced it has expanded the management and configuration capabilities of its suite of services with new Application Programming Interfaces (APIs) and web portal offerings. With these new capabilities in addition to existing APIs and Software Development Kits, developers now have more power to manage and monitor services across Limelight’s edge cloud platform. According to an IDC surveyi, more than half the organizations surveyed have already adopted DevOps practices, with an additional 20 percent planning to do so in the next 12 months. To help organizations meet these demands, Limelight has introduced expanded API capabilities to provide developers with access to the full set of configuration options available across its content delivery services. Limelight’s new Configuration API enables developers to configure Limelight services and programmatically integrate them into their workflows. It exp

Andersen Global Enters Zimbabwe20.8.2019 16:30:00 EESTPress release

Andersen Global announced it has signed a collaboration agreement with Chimwamurombe Legal Practice (Zenas) in Zimbabwe. Andersen Global has built a presence in over 14 African countries in just under two years. Zenas was founded in 2015 and now has a team of 11 professionals who provide legal services to individuals, organizations, institutions and corporations. With a specialty of serving small to medium enterprises, they offer solutions in mining and construction, commercial, debt recovery, property law, labor law, family law, tax, technology, telecommunications, media and intellectual property law, and criminal litigation. “When we started, we set out to be the most sought-after, trusted legal firm in Zimbabwe,” said Fungai Chimwamurombe, Zenas Office Managing Director. “These values line up very closely with those firms in the Andersen Global international organization. We are happy to join a team of professionals that is equally committed to treating clients like family and deliv

AnitaB.org Welcomes New Executives to Achieve Ambitious Goal of 50/50 Tech Equity by 202520.8.2019 16:00:00 EESTPress release

Today, global nonprofit AnitaB.org announced that with its recent new hires it has fully staffed its Executive Team working on the ambitious goal of 50/50 intersectional tech equity by 2025. Three new hires join its executive bench to help achieve the company’s mission: Kety Maria Esquivel as Vice President of Marketing and Communications; Robert G. Read as Vice President, Business Development and Partnership Success; and Victoria Hughes as Vice President of People and Culture. The three new appointees will join CEO and President Brenda Darden Wilkerson’s leadership team as the non-profit tech women’s organization looks to expand its global reach and continues to improve its roster of AnitaB.org/365 programs that help women and underrepresented communities gain access and career opportunity through technology. Esquivel has been brought in to lead the world-wide marketing team, bringing more than two decades of global marketing and communications experience to the role. Prior to AnitaB.

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