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    Home > Medical News > Latest Medical News > After AZ, another company's omega-3 drug clinically failed

    After AZ, another company's omega-3 drug clinically failed

    • Last Update: 2020-05-31
    • Source: Internet
    • Author: User
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    Following the heavy fall of AstraZeneca's "fish oil" product, Epanova," another omega-3 drug has failed!days ago, Acasti Pharmaceuticals' CaPre (omega-3 phospholipid) missed the main endpoint in phase III TRILOGY 1 study for the treatment of severe hyperglyceride trilipidemia (triglyceride blood level: 500-1500mg/dL)But Acasti sees a chance for CaPre, which says the study failed because of a strong drop in triglycerides in the placebo groupCaPre, similar to Vascepa and Epanova, is a omega-3-based drug designed to reduce the risk of cardiovascular disease and increase triglyceride levels in patientsBut CaPre comes from krill oil, not fish oilAccording to Acasti, the use of krill oil as a starting material will enable the main omega-3 components EPA and DHA to transport more efficiently, thereby improving absorption and reducing the synthesis of LDL-Cto test this view, Acasti launched the TRILOGY 1 study, which was tested in 242 patients with severe hyperglycinemiaThe patients were randomly divided into two groups, taking CaPre or a placebo once a day for 26 weeksresults showed a 30.5 percent decrease in triglycerides levels in the CaPre group after 12 weeks of treatment, a figure that was favorable compared to Vascepa's performance, with Amarin showing a 27 percent decrease in triglycerides during the development of the drugThe problem, however, is that CaPre's effect is not much better than placebo'In fact, after 12 weeks of treatment, the level of triglycerides in the placebo group decreased by 27.5%there was also a small difference between CaPre and placebo at other associated endpoints, including a decrease in triglyceride levels after 26 weeks of treatment (36.7 percent vs28.0 percent), and a decrease in triglyceride levels (42.2 percent vs 31.5 percent) after 12 weeks of treatment in patients receiving background statinsIt is also worth noting that both the placebo group and the CaPre group experienced significant decreases in triglyceride levels in the first 4 weeks of the study (baseline 0 weeks to 4 weeks)The placebo used in theTRILOGY research project was corn starch, a complex carbohydrate with a low glycemic index, and is therefore expected to have a neutral effect on key biomarkers in the placebo groupAccording to Acasti, the available data reveal an unusually strong placebo effect that led to a statistically significant difference in the TRILOGY 1 studythe company has counted several previous clinical trials of similar prescription omega-3 preparations to reduce triglycerides, which showed that placebo-related triglycerides in most trials declined by no more than 10 percent, up to a maximum of 17 percent Specifically, the placebo effect (using corn oil, olive oil or vegetable oil) varied from 16% to -17% in 18 intervention groups, with 14 intervention groups ranging from 10% to -10% In the Vascepa study, triglycerides levels in the placebo group increased by 10 percent to explore the placebo effect of up to -27.5% in the TRILOGY 1 study, Acasti conducted a preliminary analysis of five of the 54 clinical centers in the group and found that the five centers "disproportionately contributed to the overall effect of placebo", prompting the company to begin reviewing raw data and patient records collected by all 54 clinical centers, while also conducting a survey of whether patients continued to take or discontinue other lipid-lowering drugs during screening or during trials If the investigation comes up with a reasonable explanation, Acasti believes the company may still have a path to filing a CaPre listing application with the FDA The availability of this path depends on the results of the second Phase III study, TRILOGY 2, the top line results of which are expected to be published in March this year However, investors remain pessimistic about CaPre, with Acasti losing two-thirds of its market value on the day the TRILOGY 1 study was released However, some analysts point out that while back-to-back failures by two competitors are good for Amarin on the face of it, it may not be a good thing in the long run, especially since the mechanism of action of Vascepa is not clear, and failure of the same type of drug will leave doctors with less confidence in prescribing Therefore, for Amarin to really benefit, evidence that Vascepa and Epanova and CaPre are not all the way reference source: 1, Acasti blames phase 3 lipid-lowing flop on placebo 2, Astra and Acasti throw the Amarin more fodder
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