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    Home > Medical News > Latest Medical News > Novaral JAK inhibitor Jakavi treats hospitalized COVID-19 patients with Phase III clinical failure!

    Novaral JAK inhibitor Jakavi treats hospitalized COVID-19 patients with Phase III clinical failure!

    • Last Update: 2021-01-15
    • Source: Internet
    • Author: User
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    On December 14, Novartis announced that phase III clinical trials (RUXCOVID) for the treatment of new coronavirus pneumonia (COVID-19) hospitalized patients with oral JAK1/2 inhibitor Ruxolitinib (Jakafi/Jakavi) Joint Standard Care (SoC) had not reached the primary endpoint.
    is understood to have announced the launch of the trial in April, with partner Incyte sponsoring trials in the U.S. and Novart sponsored outside the U.S. to evaluate ruxolitinib's treatment of COVID-19-related cytokine storms (CRS), a severe immune overreaction that can cause respiratory damage in COVID-19 patients and life-threatening respiratory complications.
    Ruxolitinib is an oral JAK1/JAK2 inhibitor discovered by Incyte scientists.
    over-activation signals through the JAK-STAT pathfour are associated with a variety of cancers (bone marrow-induced tumors, etc.) and other serious immuno-mediated diseases, such as graft anti-host disease (GVHD).
    currently, ruxolitinib has been approved for three therapeutic adaptations, including bone fibrosis, true erythrocyte adhesion (PV), corticosteroid incurable acute graft anti-host disease (GVHD).
    Ruxolitinib is called Jakafi in the U.S. market and is sold by Incyte, while outside the U.S. the brand is named Jakavi, which is sold by Novartic.
    Because many patients with severe respiratory diseases caused by COVID-19, such as pneumonia, have characteristics consistent with cytokine storms and enhanced activation of the JAK-STAT pathrapy, it is speculated that ruxolitinib may play a role in the treatment of these patients.
    RUXCOVID (NCT04362137) was a multi-center, randomized, double-blind, placebo-controlled, 29-day Phase III clinical trial that assessed the efficacy and safety of ruxolitinIn-SoC therapy in patients aged ≥12 years, hospitalized for COVID-19, and who were not intestored or not cared for by the ICU in a random group.
    study included 432 patients worldwide.
    the main endpoint of the study was the proportion of patients who died within 29 days of the study, had respiratory failure (requires mechanical ventilation), or needed to enter the ICU. The
    secondary endpoints include a variety of efficacy assessments, including the use of a 9-part sequence scale to assess clinical status, hospital outcomes (mortality; proportion of patients requiring mechanical aeration; hospitalization time, ICU hospitalization time, supplemental oxygen, invasive mechanical aeration), changes in national early warning scores (NEWS2), changes in SpO2/FiO2 ratios, proportion of patients without oxygen therapy (oxygen saturation ≥94%) and safety.
    the exploratory end point is rehabilitation (no longer infected, or unlimited or minimal activity) time.
    the study, patients were randomly assigned 2:1 and received oral ruxolitinib 5mg (BID) or oral placebo twice a day for a total of 14 days.
    combined the study drug with SoC therapy based on the researchers' clinical judgment.
    14 days of treatment, patients can receive an additional 14 days of treatment if clinical symptoms or signs do not improve or worsen and the potential benefits outweigh the potential risks.
    , patients were followed for 29 days after random grouping.
    preliminary data show that by the 29th day, there was no statistically significant decrease in the proportion of patients in the ruxolitinib-SoC group who experienced serious complications (including death, mechanical ventilation due to respiratory failure, and access to the ICU) compared to the SoC group.
    the trial did not show clinically relevant benefits at secondary and exploratory endpoints (including mortality by day 29, recovery time).
    the main endpoint data were 12.0% in the ruxolitinib-SoC group and 11.8% in the placebo-SoC group (OR=0.91 (OR=0.91( 95%CI:0.48-1.73) ;p.769).
    studies, ruxolitinib is well-resistant and a comprehensive analysis, including security data, is currently under way.
    results of the RUXCOVID trial do not affect any ongoing ruxolitinib clinical trials for non-COVID-19 diseases.
    it's worth noting that in November, Novartis announced that the phase 3 CAN-COVID trial to evaluate the anti-inflammatory drug Ilaris (canakinumab, Kana monoantigen) in the same phase of SOC's treatment of COVID-19 pneumonia and CRS hospitalized patients did not reach the primary endpoint during the interim analysis.
    in patients who did not require invasive mechanical aeration, the Ilaris-Ilaris programme showed no significant improvement in survival compared to placebo-SoC.
    study did not reach the critical secondary endpoint of reducing COVID-19-related mortality within four weeks of initiating treatment.
    , Novart is making a number of contributions to the global fight against the COVID-19 pandemic and to supporting the stability of the global healthcare system.
    company has pledged $40 million to support affected communities around the world.
    , Novartic is actively involved in a number of key cross-industry research programs and partnerships.
    October, the company also announced that it was working with Swiss company Molenal Partners to develop two DARPin therapies for the treatment of COVID-19.
    same time, Novarter is developing two early-stage drugs in its pipeline, with a focus on blocking or slowing the body's immune response to COVID-19 overactive.
    the company has also launched a cooperative long-term drug discovery project aimed at developing an antiviral drug with the potential to treat all coronavirus.
    source: Novartis provides update on RUXCOVID study of ruxolitinib for the patients with COVID-19
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