Pharming Group NL0010391025

CSL Behring / Pharming group

1. [verwijderd] 15 februari 2021 19:49

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   Zou er iets kunnen spelen tussen deze 2, in de goede zin van het woord aangaande Covid-19 ??
   
   ..
   We have also begun a clinical trial for rhC1INH for the treatment of severe pneumonia resulting from COVID-19 infection in the United States.
   
   An investigational new drug application was submitted to the U.S. FDA by an investigation partner in June and taken over by us in August of 2020.
   - - -
   Evaluation of the efficacy and safety of icatibant and C1 esterase/kallikrein inhibitor in severe COVID-19: study protocol for a three-armed randomized controlled trial
   ...
   Berinert® [plasma-derived C1 esterase inhibitor (human)] will be administered at a dose of 20?IU/kg body weight on day 1 shortly after recruitment and on day 4. Each vial contains 500?IU of C1 esterase inhibitor as a lyophilized product for reconstitution with 10?mL of sterile water for injection, USP provided, following datasheet instructions. Berinert® is indicated for the treatment of acute hereditary angioedema (HAE) attacks at a dose of 20?IU/kg. The IMPACT-1 trial established the efficacy and security of Berinert® 20?IU/kg compared with placebo [15]. The most commonly observed adverse events reported on the Berinert® prescribing information are gastrointestinal symptoms [16]. Among 125 subjects enrolled in the IMPACT-1 trial, the treatment-related severe adverse reactions that occurred in 5 individuals treated with 20?IU/kg body weight were laryngeal edema, facial attack, swelling, exacerbation of hereditary angioedema, and laryngospasm.
   
   trialsjournal.biomedcentral.com/artic...
2. [verwijderd] 15 februari 2021 19:51

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   angioedemanews.com/2020/06/19/rucones...
   
   en ook hierom
   www.researchgate.net/publication/2589...
   
   en omdat steeds meer US healthcare providers Ruconest op Preferred zetten ten opzichte van Berinert ...
3. [verwijderd] 15 februari 2021 20:07

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   Discussion
   So far, there are no specific treatments for COVID-19. There is great concern regarding the duration of hospital treatment required in severe forms, because in the context of a pandemic, prolonged hospitalization means that health services may not be able to meet the demand generated by the disease. Therefore, we consider that one of the main aims for the treatment of severe pneumonia caused by COVID-19 should be to reduce the length of stay. Recent studies have shown that pulmonary inflammation and extensive lung damage in SARS patients can lead to more severe conditions [1, 2]. Furthermore, researchers have shown that SARS-CoV-2 binds to the angiotensin 2-converting enzyme (ECA2) to gain access to cells. This enzyme is fundamental both in the inactivation of angiotensin II (ANGII) and in the inactivation of bradykinin. The accumulation of bradykinin in the lungs is a common effect after the use of ECA2 inhibitors. In animal models, ECA2 inactivation leads to severe pneumonitis, and bradykinin inhibition fully recovers lung function and structure [9].
   Several previous clinical trials have already shown the efficacy of both C1 esterase and icatibant, both bradykinin inhibitors, for use in a condition called hereditary angioedema. Considering our hypothesis that the release of bradykinin could be responsible for the hyperinflammatory state of the airway in SARS-CoV-2 infection and that its inhibition could reduce such inflammation, we imagine that the use of such drugs would help reduce the complications caused by COVID-19 pneumonia and consequently reduce the duration of hospitalization. This would mean a great gain for the health system since it would allow greater patient turnover, besides reducing the chance of secondary infections inherent in a long hospitalization.