Pharming Ruconest

The Netherlands-based Pharming Group, a specialty pharmaceutical company, have seen encouraging results from it RUCONEST (recombinant human C1 inhibitor) treatment in patients with confirmed COVID-19 infections. The patients were treated under a compassionate use program at the University Hospital Basel, Switzerland.
Dr. Michael Osthoff, University Hospital Basel, Switzerland and the treating physician, said: “Although this is an uncontrolled, small treatment experience, the results demonstrate the potential effectiveness of using RUCONEST as an anti-inflammatory approach to inhibit the complement and contact systems after SARS-CoV-2 infection.”
Four male patients and one female patient (between 53-85 years of age) with COVID-19 and suffering from related severe pneumonia, who did not improve despite standard treatment, including hydroxychloroquine and lopinavir/ritonavir, were administered RUCONEST at an initial dose of 8400 U, followed by 4200 U every 12 hours for three additional doses. No allergic reactions or drug related adverse events were reported.
Following treatment with RUCONEST, fever resolved in four of the five patients within 48 hours, and laboratory markers of inflammation decreased significantly (CRP, IL-6). Soon thereafter, the patients were discharged from the hospital as fully recovered. One patient had increased oxygen requirement and was temporarily transferred to the ICU for intubation, but over the subsequent days recovered and was released from the ICU.
Following these initial results, a multinational, randomized, controlled, investigator-initiated clinical trial with up to 150 patients with confirmed COVID-19 infections, requiring hospitalisation due to significant COVID-19 related symptoms is planned. The study will be led by Dr. Osthoff.
RUCONEST® is commercialised by Pharming in the US and in Europe, and the company holds all other commercialisation rights in other countries not specified below. In some of these other countries distribution is made in association with the HAEi Global Access Program (GAP). RUCONEST is distributed in Argentina, Colombia, Costa Rica, the Dominican Republic, Panama, and Venezuela by Cytobioteck, in South Korea by HyupJin Corporation and in Israel by Kamada.
Pharming’s technology platform includes a unique production process that has proven capable of producing industrial quantities of pure high quality recombinant human proteins in a more economical and less immunogenic way compared with current cell-line based methods.