ACTG to Present Data Highlighting New Therapeutics for COVID-19 at Virtual IDWeek 2021

The AIDS Clinical Trials Group (ACTG), the world’s largest HIV research network, which recently expanded its scope to include outpatient treatment evaluation for COVID-19, today announced that Teresa H. Evering, MD, MS, Co-Principal Investigator (with Eric S. Daar, MD) for BRII-196 / BRII-198 in the ACTIV-2 Study on Ambulatory Monoclonal Antibodies and Other Therapies, will present data from the combination of monoclonal antibodies at the IDWeek 2021 virtual conference, which will be held from September 29 to October. 3, 2021.

As As SARS-CoV-2, the virus that causes COVID-19, continues to spread, there remains a significant need to develop safe and effective therapies that prevent serious illness. This presentation demonstrates that BRII-196 / BRII-198 was safe, well tolerated and demonstrated a significant reduction in the risk of hospitalization and death in adults with mild to moderate COVID-19 who were at high risk of progression to serious illness. We are delighted to present data highlighting a new therapy that may help mitigate the impact of this pandemic.. “

Judith Currier, Chair, AIDS Clinical Trials Group

Currier also did MD., M.Sc. at the University of California, Los Angeles

BRII-196 and BRII-198 (developed by Brii Biosciences) were derived from antibodies isolated from people who had recovered from COVID-19. Given as two separate infusions in a single dose, they target two different parts of SARS-CoV-2.

In an interim analysis, the combination demonstrated a 78% reduction in the combined endpoint of hospitalization and death compared to placebo in 837 outpatients with COVID-19 who were at high risk for clinical progression. In the ACTIV-2 arm receiving BRII-196 / BRII-198, there were 12 hospitalizations and one death compared to 45 hospitalizations and nine deaths in the placebo arm [2.4 vs. 11.1 percent, relative risk 0.22 (95% CI: 0.05, 0.86), P=0.00001].

Grade 3 or higher adverse events (AEs) were observed less frequently in BRII-196 / BRII-198 participants than in placebo (3.8% vs. 13.4%), with no serious infusion reactions or AEs serious drug related. Notably, the clinical benefit was similar in participants who entered the study after having had five or fewer days of symptoms and those who had symptoms for more than five days.

Between January and July 2021, ACTIV-2 recruited participants from sites in the United States, Brazil, South Africa, Mexico, Argentina and the Philippines who were randomized to receive BRII-196 / BRII-198 or a placebo. The median age of participants was 49 years; 51 percent of the participants were female, 17 percent were black, and 49 percent were Hispanic. In this interim analysis, 71 percent of participants had a visit on day 28 and 97 percent had a visit on day seven.

ACTIV-2 is a randomized, blinded, and controlled adaptive platform that allows the addition and deletion of promising therapies during the study to effectively test a variety of new agents against placebo within the same infrastructure of ‘trial. In addition to studying the safety and efficacy of experimental therapies, ACTIV-2 also aims to determine whether they can reduce viral shedding, thereby potentially preventing the transmission of SARS-CoV-2.

ACTIV-2 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), which also funds ACTG. ACTIV-2 is part of NIH’s Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program aimed at creating a coordinated research strategy that prioritizes and accelerates the development of the most promising treatments and vaccines.

It also receives support from Federal COVID Response – Therapeutics, the U.S. government’s multi-agency effort to accelerate the development, manufacture, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. The Phase 3 trial is a continuation of the Phase 2 trial in which BRII-196 / BRII-198 met the safety and efficacy criteria defined by the study.

ACTIV-2 is led by Kara Chew, MD, MS, UCLA and Davey Smith, MD, University of California at San Diego (Protocol Chairs) and David Alain Wohl, MD, University of North Carolina (UNC) and Dr Daar, Lundquist Institute at Harbor-UCLA Medical Center (vice-chairs), and supported by Dr Currier and Joseph J. Eron, MD, UNC (ACTG co-chair).