View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
August 11, 2020updated 12 Jul 2022 11:39am

Pharming begins enrolment in Covid-19 trial of Ruconest

Pharming Group has started enrolment in a clinical trial of Ruconest, a recombinant human C1 inhibitor, for the treatment of hospitalised Covid-19 patients.

Pharming Group has started enrolment in a clinical trial of Ruconest, a recombinant human C1 inhibitor, for the treatment of hospitalised Covid-19 patients.

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

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.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena