Inotrem Announces Fast Track Designation Granted by U.S. FDA to Nangibotide Development Program for the Treatment of Septic Shock
Inotrem S.A., a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nangibotide development program for the treatment of septic shock. Nangibotide, which Phase IIb has just been cleared by the FDA, 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 symptomatic treatment. Inotrem’s therapeutic solution has the potential to become the first mechanism-based treatment for septic shock.
Fast track is a designation granted by the FDA that is intended to facilitate and expedite development and review of new drugs to address an unmet medical need in the treatment of a serious life threatening condition and for which nonclinical or clinical data has demonstrated the potential to address this unmet medical need.
“FDA’s decision to grant Fast Track designation to nangibotide development program is an important recognition of both Inotrem’s innovative therapeutic approach in the management of acute inflammation and the critical need for causal therapies in a severe condition such as septic shock" said Jean-Jacques Garaud, CEO and cofounder of Inotrem.
“We look fworward to work closely with the FDA, advance our planned ASTONISH trial, and accelerate our efforts to provide the first effective therapy for septic shock patients”, added Margarita Salcedo Magguilli, CDO of Inotrem.
Inotrem recently received an IND clearance by the FDA for its ASTONISH trial (Phase IIb). The company will begin its planned global multicentric Phase IIb study in septic shock patients later this year. The Phase IIb study will aim at demonstrating efficacy of nangibotide and bring a clinically relevant proof of clinical activity in septic shock patients. 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.
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 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.
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 in Europe and in 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.
Media contact for Inotrem
+33 6 03 35 92 05
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
NIKE, Inc. Announces Board Member John Donahoe Will Succeed Mark Parker as President & CEO in 2020; Parker to Become Executive Chairman22.10.2019 20:10:00 CEST | Press release
The Board of Directors of NIKE, Inc. (NYSE:NKE) announced today that John Donahoe will be appointed as the company’s new President and Chief Executive Officer, effective Jan. 13, 2020. At the same time, Mark Parker, CEO since 2006 and Chairman, President & CEO since 2016, will become Executive Chairman and continue to lead the Board of Directors and work closely with Donahoe and the senior management team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191022006118/en/ NIKE, Inc. announces Board Member John Donahoe (right) will succeed Mark Parker (left) as President & CEO in 2020; Parker to become Executive Chairman (Photo: Business Wire) “This is an exciting time for Nike where we see brand strength and momentum throughout the world and great opportunity for future growth,” said Parker. “I am delighted John will join our team. His expertise in digital commerce, technology, global strategy and leadership combined with his s
Schlumberger Announces Senior Notes Redemption22.10.2019 20:05:00 CEST | Press release
Schlumberger Limited (“Schlumberger”) today announced that Schlumberger Holdings Corporation, an indirect wholly-owned subsidiary of Schlumberger (“SHC”), will redeem the entire outstanding principal amount of its 3.000% Senior Notes due 2020 (the “2020 Notes”), and that Cameron International Corporation, an indirect wholly-owned subsidiary of Schlumberger (“Cameron”), will redeem the entire outstanding principal amount of its 4.50% Senior Notes due 2021 (the “2021 Notes”) and the entire outstanding principal amount of its 3.60% Senior Notes due 2022 (the “2022 Notes” and, collectively with the 2020 Notes and the 2021 Notes, the “Notes”). The redemption date for each series of Notes is November 21, 2019 (the “Redemption Date”). The aggregate principal amount of the 2020 Notes outstanding is $416,044,000, the aggregate principal amount of the 2021 Notes outstanding is $126,193,000 and the aggregate principal amount of the 2022 Notes outstanding is $105,779,000. The Notes will be redeeme
CES Unveiled in Paris Highlights Emerging Tech and Artificial Intelligence22.10.2019 18:04:00 CEST | Press release
The Consumer Technology Association (CTA) ® today made several announcements at CES Unveiled in Paris, an official CES® 2020 preview event. Executives, influential media and prominent industry influencers gathered to celebrate the latest European innovations and experience a preview of CES 2020. As part of wider updates ahead of CES 2020, CTA announced that Daimler’s Ola Källenius, Chairman of the Board of Management of Daimler AG & Head of Mercedes-Benz Cars, will give a CES 2020 keynote on Monday, Jan. 6 at 8:30 PM at the Park Theater at the Park MGM Hotel in Las Vegas, NV. The event, which showcased leaders in artificial intelligence (AI) technologies, allowed attendees to see and interact with the latest innovations in AI through exhibitor displays and conference programming. AI technologies will feature prominently at CES 2020 where it will be core to solutions such as smart cities, sports tech and digital health. CTA also recognized 33 French companies announced as CES 2020 Innov
Union Acquisition Corp. II Announces Closing of $200 Million Initial Public Offering22.10.2019 17:47:00 CEST | Press release
Union Acquisition Corp. II (NASDAQ: LATNU) (the “Company”) announced today that it closed its initial public offering of 20,000,000 units, including 2,500,000 units subject to the underwriters’ over-allotment option, at $10.00 per unit. The offering was priced at $10.00 per unit, resulting in gross proceeds of $200,000,000. The Company’s units began trading on the Nasdaq Capital Market (“Nasdaq”) under the symbol “LATNU” on October 18, 2019. Each unit consists of one ordinary and one redeemable warrant with each warrant entitling the holder to purchase one ordinary share at a price of $11.50 per share. Once the securities comprising the units begin separate trading, the ordinary shares and warrants are expected to be traded on Nasdaq under the symbols “LATN” and “LATNW”, respectively. Cantor Fitzgerald & Co. acted as the sole book-running manager of the offering. EXOS Securities, LLC and Arcadia Securities, LLC acted as co-managers. Of the proceeds received from the consummation of the
TeleSign Expands Global Services through Partnership with Proximus22.10.2019 16:00:00 CEST | Press release
TeleSign, a leader in authentication and communication services, a wholly-owned subsidiary of BICS, today announced a new partnership with Proximus, the largest telecommunications company in Belgium. This partnership will provide TeleSign’s fraud risk product portfolio to provide regional and international companies with a presence in Belgium. As the mobile identity ecosystem continues to rapidly evolve globally, it is more important than ever that businesses ensure the strongest authentication and verification measures to secure end-user accounts and prevent fraud, especially in the financial sector. According to PwC, almost two-thirds (65 percent) of companies in Belgium experienced economic crime in the last two years, compared to under half (49 percent) globally. Fraud such as account take over (ATO) through SIM swap and porting attacks can be significantly expensive to both end users and businesses. With the strength of Proximus’ insights and TeleSign’s expertise, this partnership
New GSMA Study Highlights North America’s Global 5G Leadership22.10.2019 16:00:00 CEST | Press release
A new GSMA study has highlighted North America as one of the most advanced mobile regions in the world – a result of significant operator investments in 5G. The 2019 North America edition of the GSMA’s Mobile Economy report series – published today at MWC Los Angeles – forecasts that almost half of the region’s mobile connections will be running on new 5G networks by 2025. This is being fuelled by operator spending on new networks, which is forecast to total more than $380 billion (Capex) between 2018 and 2025. These investments are increasingly being focused on building-out 5G coverage across the region, enabling a range of new services for consumers and enterprise. “Our new study highlights how the North America region is vying for global 5G leadership with pioneering mobile markets such as China, Japan and South Korea,” said Mats Granryd, Director General of the GSMA. “Investments in next-generation networks and services by operators has helped create an industry that is now worth a