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August 25, 2021

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.

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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.

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COVID-19 continues to dominate headlines the world over. It has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities.  Faced with an explosion of conflicting information on how to plan and implement successful recovery strategies, decision-makers are in dire need of a single, reliable source of intelligence.   GlobalData’s COVID-19 Executive Briefing gives you access to unparalleled data and insights to successfully navigate the uncertain road to recovery across the world’s largest industries. Understand every aspect of this disruptive theme by delving into: 
  •  COVID-19 infection update, with statistics on the spread, testing by country, as well as the latest data on vaccines and therapeutic developments 
  • Economic impact overview, covering stock market indices, GDP, unemployment rates, policy responses & GlobalData’s economic recovery scorecards 
  • Sector developments, with access to sector insight summaries, cross-sector indices and the leaders and laggards in each industry vertical 
Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today. 
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