View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
August 25, 2021updated 11 Jul 2022 2:53pm

Brii Biosciences’ combination therapy lowers mortality in Covid-19 trial

BRII-196 plus BRII-198 led to a 78% reduction in relative risk of hospitalisation and mortality in Covid-19 outpatients.

Brii Biosciences has reported positive interim analysis data from the Phase III ACTIV-2 clinical trial of its combination treatment of BRII-196 plus BRII-198 in non-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.

BRII-196 and BRII-198 are non-competing SARS-CoV-2 monoclonal neutralising antibodies obtained from convalesced Covid-19 patients.

Funded by the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID), the randomised, blinded, controlled adaptive platform ACTIV-2 master protocol is led by the NIAID-sponsored AIDS Clinical Trials Group.

The ACTIV-2 trial is assessing the safety and efficacy of various experimental drugs to treat symptomatic Covid-19 in non-hospitalised adults who are at increased progression risk.

These subjects were enrolled within ten days of Covid-19 symptom onset.

The NIH initiated the Phase II/III ACTIV-2 trial of Brii Biosciences’ combination therapy in January this year.

Earlier this month, Brii Biosciences reported that the ACTIV-2 trial in the US completed enrolment for the Phase III part assessing BRII-196 plus BRII-198 for Covid-19.

The Phase III part analysed the potential of the combination therapy to prevent the composite goal of either hospitalisation or death by day 28 of the trial in 837 participants.

Data showed that the treatment provided a statistically significant decline of 78% relative risk in the combined goal versus placebo.

Based on partial follow-up of these subjects, a decline in hospitalisations, as well as deaths, was noted.

In the treatment arm, Grade 3 or higher adverse events (AEs) were seen less often, with few of the events linked to the drug.

Furthermore, drug-related serious adverse events (SAEs) or deaths were not reported in either of the arms in the trial.

The Phase III part follows a Phase II trial, where BRII-196 plus BRII-198 combination treatment met the safety and efficacy criteria of the study.

Brii Biosciences CEO Zhi Hong said: “As we all continue to research and evolve our understanding of this novel virus, Brii Biosciences is committed to advancing global standards of treatment for a broad range of patients at various stages of disease as well as those affected by the newly-emerging Covid-19 variants.

“We look forward to completing the analysis of this full data set and sharing our findings from this large global trial.”

According to the latest in vitro pseudovirus testing data, the combination therapy maintains activity against key SARS-CoV-2 variants of concern, including Alpha, Beta, Gamma, Epsilon, Delta and Lambda.

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