Hereditary vascular edema (HAE) innovative therapy! Jetbellin FXIIa inhibitor garadacimab: Reduce the number of seizures per month by 99%!
Last Update: 2020-06-17
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, June 08, 2020 /
BiovalleyBIOON/CSL Behring, a global leader in plasma protein biologics therapy, recently announced the results of theof theclinical trials of Gartacimab (formerly CSL312) PHASE IIThe drug is a new type of factor XIIa inhibitory monoclonal antibody (FXIIa-mAb) and is being developed as a monthly subcutaneous injection drug as a preventive treatment forgeneticvascular edema (HAE)data released at the 2020 DigitalConference of the European Society for Allerg
en and ClinicalImmunology (EAACI), the study reached its main endpoint: a significant decrease in the incidence of the garadacimab treatment group compared to placebosThe specific data were: Compared to the placebo group, the average percentage of HAE incidence in the garadacimgroup group - 75 mg, 200 mg, 600 mg subcutaneous injection (SC) treatment group decreased by 88.68 percent, 98.94 percent and 90.50 percent, respectivelyThe study also showed that garadacimab has good toleranceHAE is a rare,genetic,, potentially life-threatening disease that causes pain, weakness and unpredictable swelling in the abdomen, throat, face and limbs, and other parts of the body Garadacimab inhibits plasma protein FXIIa FXIIa can trigger a chain of events that cause edema to form By targeting FXIIa, garadacimab can prevent the start of this cascade reaction last month, the United States FDA granted the Garadacimab Orphan Drug (ODD) the right to prevent peptide-mediated edema, including hereditary and non-
genetic (acquired) angioedema haeemado attacks experienced by HAE patients, clinicians want to do everything they can to reduce the frequency of angioedema attacks, reduce the need for rescue drugs, and simplify treatment The findings from this Phase II study are very encouraging Jetbelin has a legacy of more than 40 years of excellence in HAE treatment innovation, and garadacimab represents a potentially pioneering (first-in-class) drug that leverages a unique approach to the development of preventive treatments for HAE Jetbellin said it would continue to advance clinical programs to deliver on its commitment to improving the lives of HAE patients hereditary angioedema-HAE (pictured from: patientworthy.com) the details of the phase II study: a multicenter, randomized, double-blind, placebo-controlled, parallel group II study (NCT03712228), which investigated the efficacy, safety, and pharmacokinetics of three different doses of garadacimab compared to placebo sabo The study included 32 adult sepsis I or II HAE patients aged 18-65 who recorded four or more cases in two consecutive months in the three months prior to screening In the study, patients were randomly assigned to receive a dose of 75 mg of garadacimab (n-9), a dose of 200 mg (n-8), a 600 mg dose (n-7) or a placebo (n-8), and were given every 4 weeks after a single intravenous dose, lasting 12 weeks The primary endpoint is the number of attacks, and the secondary endpoint includes a decrease in the number of seizures during the import period (4 weeks or 8 weeks prior to treatment), the use of monthly on-demand treatment (treatment attacks), and safety data showed that the three dose groups of garadacimab had significantly fewer seizures per month than the placebo group, with an average incidence decrease of 88.68 percent, 98.94 percent and 90.50 percent, respectively Specifically, the monthly seizure rates of the three doses of garadacimab were 0.48, 0.05 and 0.40, respectively, while the monthly incidence rate of the placebo group was 4.24 For comparison, the average monthly seizure rate was 5.17 before the study began during the study period, most patients who received garadacimab did not have seizures Specifically, the three dose groups of garadacimab had 55.56 per cent, 87.5 per cent and 42.86 per cent of patients without any seizures, compared with 0 per cent in the placebo group the study, all adverse events were mild or moderate, and in all groups, the percentage of patients who experienced adverse events (TEAE) during at least one treatment was similar The common TEAE is the erythema (12.5%) at the light and moderate injection site (biovalleybioon.com) original source: CSL Behring Presents Results for Garadacimab as Serctin Treatment in Hereditary Angioedema
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