A phase IIb trial of nangibotide in septic shock has demonstrated preliminary signs of efficacy in a subset of biomarker-defined patients and provided its developer, Inotrem SA, with a dataset that will inform the design of a registration program for the drug. Subject to agreement from regulatory agencies, the company aims to move the triggering receptor on myeloid cells 1 inhibitor into a first phase III trial in early 2024. “We should have a clearer picture by the beginning of the second next year,” CEO Sven Zimmermann told BioWorld.
Scientists have discovered that the enzyme aconitate decarboxylase 1 is not an anti-inflammatory mediator in sepsis. In the presence of bacterial toxins, it is involved in the cytokine storm and inflammatory signaling in monocytes and macrophages, becoming a potential therapeutic target against the infection.
Becton, Dickinson and Co. and Accelerate Diagnostics Inc. joined forces to knock out sepsis and put patients on the path to recovery in hours, not days.
T2 Biosystems Inc. is accelerating development of its T2biothreat and T2resistance panels, direct-from-blood panels that detect the six pathogens most likely to be weaponized and 13 common antibiotic resistance genes, respectively. A $4.4 million Biomedical Advanced Research and Development Authority (BARDA) cost-sharing contract will be used to advance clinical trials for the tests. The total potential funding from BARDA under the contract is $69 million.
Noninvasix Inc. received a breakthrough device designation from the FDA for its noninvasive Livox central venous oxygenation monitor, which allows real-time monitoring of central venous oxygen saturation (ScvO2) in patients at risk of septic shock. The Noninvasix optoacoustic platform consists of a disposable patient interface with a reusable probe, data display and hardware.
PERTH, Australia – The FDA has cleared Immunexpress Inc.’s 510(k) for its Septicyte rapid diagnostic test for sepsis that quantifies the relative expression levels of genes involved in a patient's immune response to infection to aid in a diagnosis in one hour for patients suspected of sepsis. The test uses peripheral blood gene expression biomarkers to provide a probability of sepsis in patients presenting with clinical signs of systemic inflammation.
TORONTO – Trillium Health Partners has received a C$1 million (US$810,000) grant from TD Bank Group to help accelerate the use of artificial intelligence (AI) at a newly developed health care lab. The AI Deployment and Evaluation (AIDE) lab will determine if machine learning models developed by industry and academia work well outside the data sets upon which they were trained.
TORONTO – Health Gauge Inc. (HG) and AI-on-Call Inc. will soon deploy a digital remote patient monitoring solution for early prediction of sepsis at three seniors' facilities located in British Columbia. HG’s smartwatch and AI-driven cloud platform capture an array of vital signs data, including blood pressure, heart and respiratory rates, and will be supported by AI-on-Call software that alerts medical staff to early signs of sepsis and acute illness.
DUBLIN – With more than six months to go before an initial interim readout from its phase III pivotal trial of ilofotase alfa (recombinant human alkaline phosphatase) in sepsis-associated acute kidney injury (SA-AKI), AM-Pharma BV has already found a buyer for Japanese rights to the product. Kyowa Kirin Co. Ltd. is paying €20 million up front and could pay up to €225 million more in milestones attached to the progress of the program.
DUBLIN – Inotrem SA has received €45 million (US$53 million) in public funding commitments to move its Trem-1 inhibitor, nangibotide, into a phase II/III trial in COVID-19 patients who are critically ill and on ventilation.
