Pharming enrols first patient in Ruconest COVID-19 study

10-Dec-2020

It follows a study into the use of Ruconest in the prevention of severe SARS-CoV-2 infections in patients hospitalised with related severe pneumonia

Pharming has announced the first patient has been enrolled in a randomised, open label, parallel group, controlled, pilot clinical trial in up to 120 patients hospitalised with confirmed COVID-19 treated with Ruconest (recombinant human C1 inhibitor) for the prevention of severe SARS-CoV-2 infections at the Valley Hospital in Ridgewood, New Jersey in the United States.

The trial is planned to include patients at multiple centres in the US. It follows a study into the use of Ruconest in the prevention of severe SARS-CoV-2 infections in patients hospitalised with related severe pneumonia. Pharming announced the enrolment of the first patient in that trial in August this year.

Ruconest is a recombinant C1 esterase inhibitor (C1INH) approved for the treatment of hereditary angioedema (HAE) in Europe and the US. C1INH is a protein that naturally occurs in the human body. It regulates several inflammatory pathways in the body by inhibiting certain proteins that are part of the human immune system.

Systemic hyper-inflammation is a hallmark of more severe stages of COVID-19 leading to acute respiratory distress syndrome. Pharming says treatment with Ruconest may “dampen uncontrolled complement activation and collateral lung damage; reduce capillary leakage and subsequent pulmonary edema by direct inhibition of the kallikrein-kinin system; and reduce the generation of microthrombi by inhibiting MASP-1 induced clot formation and factor XII amplified thrombo-inflammation”.

C1 inhibitor is an acute phase reactant, meaning the body naturally increases production during inflammatory conditions, such as infections. Despite this, a relative deficiency may occur and complement activation continues unchecked, often leading to a cytokine storm, a dangerous biochemical process that worsens the complications of COVID-19 infection, such as organ failure and death.

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Pharming’s current clinical study seeks to find out if additional C1INH can mitigate these dangerous complications. Headline data will be made publicly available following either an interim analysis or after all patients have been treated.

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