Business Wire

Inotrem Announces Positive Outcome of Interim Futility Analysis for Its Phase IIB ASTONISH Trial in Septic Shock Patients to Demonstrate Nangibotide Efficacy

Share

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.

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

DC Secretary Announces Annual Determinations Committees Outcome28.3.2024 23:14:00 EET | Press release

DC Administration Services, Inc. has today announced the composition of five regional Determinations Committees (DCs), effective from April 27, 2024. Voting Dealers (for all regions): Voting Non-Dealers (for all regions): Bank of America N.A. Citadel LLC Barclays Bank plc Elliott Management Corporation BNP Paribas Pacific Investment Management Company LLC Citibank, N.A. Deutsche Bank AG Goldman Sachs International JPMorgan Chase Bank, N.A. Voting Dealer for the Americas, EMEA, AEJ, and Japan Determination Committees: Mizuho Securities Co., Ltd. The process for selecting DC members is specified in the DC rules. The DC rules, along with more information about the Determinations Committees and what they do can be found at the Determinations Committees website: https://www.cdsdeterminationscommittees.org/. View source version on businesswire.com: https://www.businesswire.com/news/home/20240328441002/en/ Contact information Press Inquiries: Orlando Figueroa orlando.figueroa@citadelspv.com

Faster Recoveries, Improved Security: HTEC and G2 Risk Solutions Join Forces to Advance Bankruptcy Management28.3.2024 19:02:00 EET | Press release

HTEC, a global digital consulting, software engineering, and product development company, is announcing a strategic collaboration with G2 Risk Solutions (G2RS), the preeminent provider of end-to-end bankruptcy technology solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240328622816/en/ HTEC & G2 Risk Solutions Partnership (Photo: Business Wire) Under the agreement, G2RS will engage HTEC to incorporate its leading-edge technology into G2RS’ premier bankruptcy management platform. As the creators of the most comprehensive national bankruptcy database and the first bankruptcy management portal, G2RS is an industry pioneer. By adding HTEC’s premium engineering to the G2RS technology stack, G2RS will offer new and innovative functionalities to help clients expedite financial recoveries, increase data protection, and reduce operational inefficiencies in the bankruptcy management life cycle. “We are thrilled to be a part o

LambdaTest Launches The Phoenix Project, an Employee Resource Group for Women28.3.2024 18:00:00 EET | Press release

LambdaTest, a leading cloud-based unified testing platform, announced the launch of The Phoenix Project, an Employee Resource Group (ERG) dedicated to supporting and promoting the success of its female employees. “LambdaTest is committed to fostering a diverse, inclusive, and equitable workplace where all employees feel valued and empowered to reach their full potential,” said Chandini Chopra, VP of People and Culture at LambdaTest. “The Phoenix Project is a critical step towards achieving this goal by providing a platform for professional development, networking, and mentorship, especially for our women employees.” The Phoenix Project Aims To: Offer professional development workshops, networking opportunities, and dedicated time off for women to participate in ERG initiatives. Provide mentorship programs connecting senior female employees with mentees. Promote leadership development among women within the company. Create a sense of community for women in the workplace. Leadership and

The reopening of the Yokohama Museum of Art adds another innovative and distinctive venue for events in Yokohama28.3.2024 18:00:00 EET | Press release

After extensive renovations, the iconic Yokohama Museum of Art has reopened its doors to visitors from all over the world. The museum’s reopening paves the way to new and closer collaboration with international events in Yokohama. This extraordinary venue is the ideal setting for a one-of-a-kind gathering, in part, supported by the Yokohama Convention & Visitors Bureau (hereinafter YCVB). The Yokohama Museum of Art Founded in 1989, the Yokohama Museum of Art collects over 14,000 works of art that reflect the many facets of life in Yokohama—past, present, and future. The reopening of the museum coincides with the Yokohama Triennale, an international exhibition featuring contemporary artists whose decentralized exhibits turn the entire metropolis into an art museum. The 8th Yokohama Triennale is being held from March 15 to June 9, 2024, with the Yokohama Museum of Art being a pivotal venue for the exhibition. With the museum firmly back on the map as Yokohama’s leading artistic venue, YC

Eight new sustainability-themed experiences—exclusive to Yokohama—for convention participants28.3.2024 18:00:00 EET | Press release

In a survey conducted by Yokohama Convention & Visitors Bureau (hereinafter YCVB), many convention attendees expressed particular interest in Yokohama’s culture, sightseeing spots, and local cuisine. In response, YCVB has developed eight new Yokohama Tours for event attendees to enjoy during their free time in Yokohama, keeping in line with our ethos of sustainability. Noge Area Bar-Hopping Tour, complete with guide Known affectionately by locals as Yokohama’s kitchen, Noge is a bustling nightlife spot that is home to over 600 izakaya (Japanese-style pubs). A knowledgeable local guide will lead participants to all the hidden gems in Noge, where they can indulge in distinctive, delicious pub-style food and drink. With easy on-foot accessibility, participants can rest assured this fun night out won’t impact their carbon footprint. Soto Zen Tour of Sojiji, head temple of the Soto Zen school As a prominent Zen sect in Japan, Soto Zen provides one of the best Zen wellness experiences. Durin

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
HiddenA line styled icon from Orion Icon Library.Eye