Inotrem Announces Positive Outcome of Interim Futility Analysis for Its Phase IIB ASTONISH Trial in Septic Shock Patients to Demonstrate Nangibotide Efficacy
Inotrem, an advanced clinical stage biotech company specialized in immunotherapies for acute and chronic inflammatory syndromes, announced today that the ASTONISH Independent Data Monitoring Committee (IDMC) completed the planned safety and efficacy assessment for futility of the company’s ongoing Phase IIB ASTONISH trial in septic shock patients.
The ASTONISH Phase IIB study aims at demonstrating safety and clinical efficacy of nangibotide in septic shock patients. It is a global, multicentric study conducted in 48 centers. Four hundred and fifty patients are planned to be enrolled in this study. The study compares the effect of nangibotide at two different doses versus standard of care. The futility analysis has been conducted on the first 225 patients enrolled. The primary endpoint for futility analysis was the delta SOFA score between the treatment groups and the standard of care/placebo group at day 5. A delta of 1 to 1.5 was observed in a previous Phase IIa trial in a subpopulation of septic shock patients with high concentration of soluble TREM-1, a mechanism-based biomarker. In addition, the ASTONISH 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 IDMC’s decision marks a significant milestone for Inotrem’s development as it triggers the payment of the second tranche of €17 million of the Series B financing raised in 2020 from top-tier international investors.
“We are pleased with the IDMC's recommendation to continue the ASTONISH trial as it advances our understanding of the safety, tolerability and efficacy of nangibotide, our lead drug candidate, for septic shock patients. It is an important step toward establishing a potential new treatment for septic shock, a severe and often fatal condition for which there are currently no specific targeted therapies”, said Jean-Jacques Garaud, Executive Vice-President, Head of Scientific and Medical Affairs and Inotrem’s co-founder.
“We look forward to sharing updates from the ASTONISH trial in the coming months. The payment of this €17 million tranche strengthens our strategic ability to move towards the completion of our the septic shock program as well as the active development of our drug pipeline in chronic inflammatory conditions”, said Sven Zimmermann, CEO of Inotrem.
Septic shock is the ultimate complication of sepsis and currently constitutes a high unmet medical need. It represents a significant economic burden for the European healthcare system. Recent works have also emphasized the health economic impact of long term patients’ outcomes; indeed 30% of septic shock survivors are re-hospitalized in the three months following a first shock and between 20% and 30% have long term morbidities at twelve months. The incidence of septic shock is bound to increase as the population ages, leading to a rise in ICU admissions. Elderly patients are predisposed to septic shock due to existing co-morbidities, repeated and prolonged hospitalizations, reduced immunity, functional limitations and as well as the effects of aging itself. Europe is therefore poised to see a continuous rise in septic shock in the coming decades. We estimate that by 2025 the incidence of septic shock in Europe will be as high as 500,000 cases leading to 150,000 deaths per year. 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.
About Inotrem
Inotrem S.A. is an advanced clinical stage biotech company specialized in immunotherapy for 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, nangibotide, with potential applications in a number of therapeutic indications such as septic shock and COVID-19. In parallel, Inotrem has launched a program to develop new therapeutic modalities 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. For more information please visit: www.inotrem.com
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/20210609005565/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
Proteintech Group Celebrates 20-Year Anniversary15.6.2021 18:09:00 EEST | Press release
Proteintech Group, a leading manufacturer of antibodies and related products, is celebrating the 20th anniversary of its founding. To celebrate the achievements and challenges of the past years, Proteintech will host special events throughout the year with its customers, collaborators, and employees while still looking forward to future opportunities. “Over the years we have witnessed countless discoveries and we couldn’t be prouder of everything our customers have achieved. We want to thank all of our customer for their tireless efforts and sacrifices to advance scientific discovery,” Dr. Jason Li, CEO Proteintech Group was founded in early 2001 by a small group of scientists including its current CEO, Dr. Jason Li. The founders set out with a vision to produce an antibody for every single protein coded in the human genome. Comprehensive coverage of all human gene products is a massive undertaking, but critical because it is difficult for researchers to predict which targets may be re
Norsk Titanium Expands into the Industrial Application Market in Collaboration with Hittech Group15.6.2021 18:00:00 EEST | Press release
Norsk Titanium AS (Norsk Titanium; Euronext: NTI), a global leader in additive manufacturing of aerospace-grade titanium components, announced an expansion of its customer base into the industrial application market sector in collaboration with the Hittech Group, based in Den Haag, Netherlands. The production of the first industrial component in this development supports a Hittech end customer in the growing semiconductor equipment market. Norsk expects significant near-term investment by manufacturers in the semiconductor market as they seek to modernize their supply chains. This effort represents Norsk’s first step to support these modernization efforts with a faster, more cost efficient and environmentally friendly approach. Using Norsk’s revolutionary Rapid Plasma Deposition™ (RPD™) process, Norsk engineers have designed a titanium alloy preform that will reduce Hittech’s raw material needs by over 45 percent as compared to legacy wrought product used to fabricate the end component
i2c Becomes First Company to be a Visa Fintech Fast Track Member in Four Regions15.6.2021 17:15:00 EEST | Press release
i2c, a leading provider of digital payment and banking technology, today announced the extension of its membership in Visa’s Fintech Fast Track program to the Asia-Pacific region (AP), making it the first company to become an enablement partner in all four regions of the acclaimed program. As an enablement partner, i2c helps lay the foundation for fintechs to build and expand their products locally, regionally or globally over its single stack, modular platform. Designed to accelerate the process of integrating with Visa, the Fintech Fast Track program brings together services and expertise to support fintech companies in their efforts to launch payments solutions. Partners leverage the payment network’s reach, capabilities, and security to realize faster onboarding times, and allow fintechs to scale more quickly. “We are excited to be able to simplify the process of launching a card program in 10 more countries, as an extension of our commitment to being a truly global partner for our
Viking Malt: Foundation Stone Laid: Construction of the New Production Plant in Lahti, Finland, is Progressing as Planned15.6.2021 17:04:00 EEST | Press release
Viking Malt has laid the foundation stone for its new production plant in Lahti. The plan is that the new malting house will start its operations in 2023. It is about 90 million euro project in size and the production capacity will be ca. 85 000 tons per year. Owner Pär-Gustaf Relander and CEO Kasper Madsen hosted the ceremony at the construction site on Pippo-Kujala industrial area. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210615005825/en/ The time capsule and the representants from Construction Consultant Afry, Viking Malt and the Mayor of Lahti, Pekka Timonen. Photo by Viking Malt. The company is already over 130 years old and the key to success has always been to focus on high quality and to be open to innovation and new technology. The new plant is a continuation of this tradition. Building a new plant gives a unique opportunity to utilize the newest technology to both increase efficiency and to become more enviro
New Data Shows $30 Billion Streaming Advertising Disconnect Among Publishers, Brands and Consumers15.6.2021 17:00:00 EEST | Press release
Conviva, the intelligence cloud for streaming media, released its inaugural State of Streaming Advertising report today, revealing big gaps in how publishers, buyers and consumers perceive streaming ads, and what this means for the future of the multibillion dollar streaming ad industry. For example, while 69% of sellers believe ad quality on streaming is as good as on linear television, just over half of buyers feel similarly (55%) and only about a third of consumers agree (35%). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210615005329/en/ Conviva's State of Streaming Advertising 2021 (Graphic: Business Wire) “With streaming, there is an opportunity to provide high-quality creative to consumers, but we need to evaluate how and when we reach them,” said Scott McDonald, President & CEO, Advertising Research Foundation (ARF). “It’s time to move on from 1:1 targeting, with growing concerns over privacy and the challenge of s
LiveRamp and Carrefour Partner to Deliver Next-Generation Retail Offerings15.6.2021 16:30:00 EEST | Press release
LiveRamp® (NYSE: RAMP) today announced an expanded global partnership with Carrefour (OTCMKTS: CRERF) to enable robust data collaboration, analytics and innovation capabilities through LiveRamp’s Safe Haven. Using LiveRamp’s best-in-class privacy-preserving technologies, retailers, consumer packaged goods (CPGs) brands and Carrefour partners can execute safe, simple and productive data collaboration on an unprecedented global scale. Safe Haven is currently available in the U.S., UK, France, China, Japan and Australia, and, with Carrefour, is expanding to Spain, Italy, Belgium, Poland, Romania, Argentina, Brazil and Taiwan. LiveRamp’s Safe Haven is part of a new business unit that Carrefour is launching on this occasion: “Carrefour Links.” The partnership was announced at a press conference in Paris today. “LiveRamp will be a critical accelerator of Carrefour’s transformation into an industry-leading data-driven retailer,” said Elodie Perthuisot, Executive Director E-Commerce, Data and
Andersen Global Extends Coverage With Law Firm in Antigua and Barbuda15.6.2021 16:30:00 EEST | Press release
Andersen Global strengthens its Caribbean foothold with collaborating firm Richards & Company in Antigua and Barbuda, adding coverage to the region’s southern edge. Founded in 1999 by Managing Partner Stacy Richards-Roach, the full-service law firm is located in St. John’s and provides a broad range of legal services to individuals, businesses and corporations in various industries. The firm’s capabilities include intellectual property, civil litigation, company formation and business set up, commercial law, banking and real estate. “Our primary objectives are to provide our clients with effective and innovative solutions,” said Stacy. “Collaborating with Andersen Global will continue to drive our firm’s objectives forward and provide us with the ability to deliver best-in-class, independent solutions regardless of borders.” Andersen Global Chairman and Andersen CEO Mark Vorsatz added, “The addition of Richards & Company to our Caribbean platform represents our ambitious strategy to be
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