Pharming Group has started enrolment in a clinical trial of Ruconest, a recombinant human C1 inhibitor, for the treatment of hospitalised Covid-19 patients.
The randomised, controlled, investigator-initiated study is recruiting patients with Covid-19-associated severe pneumonia at the University Hospital Basel in Basel, Switzerland.
In April this year, the company announced promising data from a compassionate use programme at the University Hospital Basel.
As part of the programme, five patients with Covid-19-related severe pneumonia who did not improve on standard therapies such as hydroxychloroquine and lopinavir/ritonavir were given Ruconest.
After treatment, fever resolved in four of the five patients within two days. A significant decrease was also observed in laboratory markers of inflammation (CRP, IL-6).
These four patients were discharged from the hospital after fully recovering, while one patient had increased oxygen requirement and was admitted to the ICU, but later fully recovered.
Based on these findings, the company launched a larger investigator-initiated trial to assess the full extent of the role of its drug in treating severe pneumonia caused by Covid-19.
If positive data is obtained in the clinical trial, Pharming may conduct additional studies of Ruconest in patients with other diseases that lead to severe respiratory or other organ failure complications.
Pharming chief medical officer Bruno Giannetti said: “Ruconest’s multiple interactions with key inflammation pathways therefore make it a promising candidate to prevent the severe complications observed in Covid-19 patients.
“This investigator-initiated clinical trial in partnership with Dr Michael Osthoff will be important, not only for the treatment of pneumonia as a result of Covid-19 infection, but will also provide key insight into the future treatment of complement system influenced diseases.”
The drug is indicated in the US and EU to treat hereditary angioedema.