Industry milestone | FDA adopts IND declaration based solely on organ chip data

Industry milestone | FDA adopts IND declaration completely based on organ chip data

2022-07-13

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& nbsp; & nbsp; On February 24, 2022, clinical stage pharmaceutical companies Cantex and Wyss Institute of Biomimetic Engineering at Harvard University announced that Cantex has obtained a global license from the Harvard Office of Technology Development (OTD) to develop Azeliragon for the treatment of inflammatory lung disease, including COVID-19

& nbsp; & nbsp;& nbsp; Azeliragon is a drug that binds to a protein called RAGE (receptor for advanced glycation end products) on the cell membrane and inhibits its activity. When lung cells are damaged by viral or bacterial infections or airway irritants, they release DAMP molecules that bind to and activate RAGE. RAGE is more expressed in the lungs than in any other organ in the human body and is considered a major inflammatory mediator in several lung diseases, including acute lung injury, chronic obstructive pulmonary disease (COPD), and asthma. Azeliragon prevents RAGE from being activated by its normal binding molecules, thereby reducing inflammation. It is currently the only oral small molecule RAGE inhibitor in human clinical trials

& nbsp; & nbsp;& nbsp; At the same time, studies have shown that RAGE inhibitors can improve inflammation and lung injury caused by COVID-19 in mice. However, due to species differences, the pathogenesis of COVID-19 after infection in animal models is different from that observed in humans

& nbsp; & nbsp;& nbsp; Therefore, Wyss Institute conducted research on the drug in human alveolar chips to verify whether Azeliragon can also achieve clear therapeutic effects in humans. Research has confirmed that Azeliragon significantly blocks the production of inflammatory cytokines, including IL-6, IL-8, IP-10, and RANTES

& nbsp; & nbsp;& nbsp; Based on high-level safety results in human clinical trials and Wyss Institute'sOrgan chipData shows that it can reduce virus-related inflammatory reactions in human lung tissue. The FDA has approved Azeliragon to directly conduct phase II clinical trials for hospitalized patients with severe COVID-19, while also allowing for other pulmonary inflammatory diseases such as chronic obstructive pulmonary disease, COPD, and steroid refractory asthma Conduct clinical trials

& nbsp; & nbsp;& nbsp; Donald Ingber, founding director of the Wyss Institute, said, "I am very proud of the speed with which our team at the Wyss Institute has responded to the COVID-19 crisis, and I am also very grateful to humanity=“ http://www.daxiangbio.com/ " target="_ Blank "title=" Industry milestone | FDA adopts IND declaration based entirely on organ chip data "style=" white space: normal; ">Organ microarrayThe potential of organ microarray application in the study of the mechanism of virus infection related inflammation is very confident. We are eager to see this potentially life-saving therapy enter clinical trials at the same speed, and ultimately benefit patients, ultimately helping to curb the continued global COVID-19 pandemic and solve other inflammatory diseases."