Business Wire

Inotrem Announces Publication of Two Key Articles on Nangibotide Phase II Programs in Peer-reviewed Medical Journals

Share

Inotrem, an advanced clinical stage biotech company specializing in immunotherapies for acute and chronic inflammatory conditions, announced today the publication of the results of two phase 2 clinical studies in the The Lancet Respiratory Medicine and in eClinicalMedicine. The first article presents the ASTONISH Phase 2b trial in septic shock patients and the second one the ESSENTIAL Phase 2 trial for the treatment of critically ill COVID-19 patients. Both studies reveal that the TREM-1 pathway plays a central role in major life-threatening immune dysregulations caused by severe infections, whether it is septic shock or severe forms of COVID-19. The findings presented further validate Inotrem’s innovative approach to treat inflammatory diseases by targeting TREM-1.

The two studies suggest that nangibotide, which targets TREM-1, is pathogen agnostic and has the potential to treat those very severe inflammatory conditions caused by both viral and bacterial infections. Both studies highlight the potential of nangibotide in the treatment of septic shock patients and of patients with severe forms of COVID-19 with a biomarker guided approach using soluble TREM-1 as predictive marker of response to targeted therapy.

The first manuscript in The Lancet Respiratory Medicine is entitled “Prospective evaluation of the efficacy, safety, and the optimal biomarker enrichment strategy for nangibotide, a TREM-1 inhibitor, in patients with septic shock: a double-blind, randomized, controlled, phase 2b trial” and presents results from 355 septic shock patients. The primary outcome was the change in SOFA at day 5 compared to placebo in the pre-defined high soluble TREM-1 (≥ 400 pg/ml) group and in the overall population. Planned evaluation of the optimal sTREM-1 cut-off revealed increased clinically relevant benefits of high dose nangibotide at higher cutoffs (sTREM-1 ≥ 532 pg/ml). The manuscript can be accessed via the following link: The Lancet Respiratory Medicine.

The second manuscript in eClinicalMedicine, entitled “Evaluation of the efficacy and safety of TREM-1 inhibition with nangibotide in patients with COVID19 receiving respiratory support: results of the ESSENTIAL randomized, double-blind trial” presents the Phase 2 results obtained in 220 COVID-19 patients receiving ventilatory support. In this study, nangibotide has a significant and positive impact on the clinical progression of the disease, as well as on the severity of the respiratory failure, secondary infection rates and notably mortality. The trial showed that sTREM-1 is an effective prognostic marker of outcome in severe COVID-19. The manuscript can be accessed via the following link: eClinicalMedicine.

“Nangibotide is the first TREM-1 inhibitor and has the potential to become the first causal treatment of life-threatening immune dysregulations. This is an area with a major unmet medical need” said Professor Bruno François, Limoges University Hospital, and lead author on the two manuscripts.

“We are excited to see this data published in The Lancet Respiratory Medicine and in eClinicalMedicine, two of the most established peer-reviewed medical journals in our field. These two publications come as a strong recognition of Inotrem’s innovative scientific leadership regarding the role of the TREM-1 pathway and of our solid therapeutic approaches” said Sven Zimmermann, CEO of Inotrem. “We look forward to bringing this potential new treatment option to patients suffering from severe and often fatal inflammatory conditions.”

About nangibotide
Nangibotide is a TREM-1 inhibitor peptide with the potential to restore appropriate inflammatory response, vascular function, and improve post septic shock survival. 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 and the PRIME status in 2017 by the EMA.

About ASTONISH Study
The Efficacy, Safety and Tolerability of nangibotide in Patients with Septic Shock (ASTONISH) phase 2b trial is a Randomized, Double-blind, Placebo Controlled Dose Selection Study that was performed in Europe and in the US. The study compared the effect of nangibotide at two different doses (0.3 and 1mg/kg/h continuous i.v. infusion for 3 to 5 days) versus standard of care. Results for Phase IIb ASTONISH clinical trial in septic shock patients were disclosed for the first time at the International Sepsis Forum held in Barcelona on October 13. 2022.

About ESSENTIAL Study
The ESSENTIAL phase 2 trial is a double-blind randomized controlled trial assessing efficacy, safety, and optimum treatment population of nangibotide (1·0 mg/kg/h) compared to placebo. The study was stopped after 220 patients had been recruited; of them, 219 were included in the mITT analysis. Patients aged 18-75 years were eligible within 7 days of SARS-CoV-2 documentation and within 48 hours of onset invasive or non-invasive respiratory support because of COVID-19-related ARDS. ESSENTIAL data were disclosed for the first time at the ESICM meeting held in Paris in October 25. 2022.

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. 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, severe forms of COVID-19 and myocardial infarction. In parallel, Inotrem has also launched an antibody-based 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 Inotrem is part of the French Tech 120, a government program dedicated to support the development of fast-growing startups. 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
Strategies & Image (S&I)
anne.rein@strategiesimage.com
+33 6 03 35 92 0

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

Incyte to Present Multiple Studies from Dermatology Portfolio at 2023 European Academy of Dermatology and Venereology (EADV) Congress29.9.2023 20:43:00 EEST | Press release

Incyte (Nasdaq:INCY) today announced multiple abstracts featuring new data from across its dermatology portfolio have been accepted for presentation at the upcoming European Academy of Dermatology and Venereology (EADV) Congress 2023 held October 11-14 in Berlin. “We are pleased to add to the data supporting the use of ruxolitinib cream for patients living with vitiligo and atopic dermatitis (AD) through two late-breaking presentations – one on prolonged use of treatment in vitiligo patients with limited or no initial response, and the full results of our TRuE-AD3 trial in pediatric AD,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “Collectively, the data at this year's Congress, which also include new late-breaking data for povorcitinib in vitiligo, emphasize our ongoing efforts to advance treatment options for the Dermatology community." Key abstracts from Incyte-sponsored programs include: Late-breaking Oral Presentations Vitiligo Efficacy an

Q4 Inc. Recognized as one of Canada’s Top Growing Companies by The Globe and Mail29.9.2023 17:30:00 EEST | Press release

Q4 Inc. (TSX: QFOR) (“Q4” or “the Company”), the leading capital markets access platform, is pleased to announce their ranking on the 2023 Report on Business of Canada’s Top Growing Companies. Canada’s Top Growing Companies ranks Canadian companies on three-year revenue growth. Q4 earned its spot with three-year growth of 150%. “We are honored to be recognized as one of Canada’s Top Growing Companies for the fourth consecutive year by The Globe and Mail,” remarked Darrell Heaps, Founder and CEO of Q4. “We are proud of the growth we have achieved as a company and this recognition is a true reflection of our dedication to helping our clients win in the capital markets through innovative technology on the Q4 Platform.” Canada’s Top Growing Companies is an editorial ranking that was launched in 2019. It aims to bring the accomplishments of innovative businesses in Canada to the forefront. In order to qualify for this voluntary program; companies had to complete an in-depth application proc

GEDi Cube and Renovaro Biosciences Sign Definitive Agreement to Combine29.9.2023 16:15:00 EEST | Press release

GEDi Cube Intl Ltd. (GEDi Cube), an AI medical technology company, and Renovaro Biosciences Inc. (NASDAQ:RENB) (Renovaro), an advanced, preclinical biotechnology firm in cell, gene and immunotherapy, have signed a definitive agreement to combine, in which GEDi Cube will become a wholly-owned subsidiary of Renovaro in a stock-for-stock acquisition (the “Transaction”). If completed, the Transaction will result in a combined company that will offer advanced early diagnosis and early identification of recurring cancer as well as potential therapies for several critical diseases such as pancreatic cancer and other solid tumors with poor life expectancy. The combined company will have a unique advantage: Renovaro Biosciences’ pre-clinical and clinical trial data could be utilized to accelerate GEDi Cube’s AI capabilities that, in turn, could potentially help to accelerate Renovaro’s development of potential new therapies. AI will be used to advance the fields of diagnosis and treatment with

Offshore Windfarm Hollandse Kust Zuid Inaugurated29.9.2023 14:53:00 EEST | Press release

Today, Dutch King Willem-Alexander jointly with the board members of Vattenfall, BASF, and Allianz officially inaugurated the offshore wind farm Hollandse Kust Zuid 1-4. The wind farm is in the North Sea, 18-36 kilometers off the Dutch coast between the towns of Scheveningen and Zandvoort. The 139 turbines have a total capacity of 1.5 GW, making it one of the largest offshore wind farms in the world. The annual electricity production is expected to equal the consumption of 1.5 million households. Hollandse Kust Zuid is owned by Vattenfall, BASF, and Allianz. The wind farm is expected to be fully operational in 2024 and will be serviced out of the port of IJmuiden. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230929518869/en/ Inauguration Hollandse Kust Zuid wind farm. From left to right: Helene Biström (Senior Vice President, Head of Business Area Wind Vattenfall), Martijn Hagens (CEO Vattenfall Netherlands), His Majesty K

The Estée Lauder Companies Launches 2023 Breast Cancer Campaign: Beautifully United to Help End Breast Cancer29.9.2023 14:00:00 EEST | Press release

For more than 30 years, The Estée Lauder Companies’ Breast Cancer Campaign (The Campaign) has been dedicated to advancing the possibility of a breast cancer-free world for all. This October, The Estée Lauder Companies (ELC) honors Breast Cancer Awareness Month by launching The Campaign in support of the global breast cancer community. As ELC’s largest corporate social impact program, The Campaign continues to inspire purpose-driven action and is a cornerstone of the company’s social investments in women’s advancement, health and education. Through The Campaign, ELC has also been a longstanding supporter of women in science, research and medicine – funding numerous grants and programs around the world and accelerating opportunities for women in STEM. The Campaign was founded by Evelyn H. Lauder in 1992 with the launch of the iconic Pink Ribbon. At a time when breast cancer wasn’t spoken about openly, Evelyn and ELC saw an opportunity to bring awareness to the disease and address stigmas

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