Another Covid-19 antibody cocktail on the menu? Brii Bio touts early win in NIH study for a combo already used in China
Months after flopping in an NIH-sponsored study, Brii Biosciences’ Covid-19 antibody combo has redeemed itself in a second trial.
The biotech says its antibodies — which had hailed from Beijing’s Tsinghua University and Shenzhen Third People’s Hospital — dramatically improved patients’ odds of getting hospitalized or dying over placebo, notching a statistically significant reduction of 78%. That translates to a risk ratio of 0.22 (95% confidence interval: 0.05, 0.86; p<.00001).
Specifically, when investigators did a partial followup on the 837 non-hospitalized patients enrolled in this arm of ACTIV-2 trial at an interim analysis, they found:
[A] reduction in both hospitalizations 12 (active) vs 45 (placebo) and deaths 1 (active) vs 9 (placebo), was observed. Additional subgroup analysis may further delineate the clinical benefits of early (≤5 days) versus late (6-10 days) treatment with BRII-196/BRII-198 following symptom onset, providing unique insight to inform real-world treatment decisions.
The findings fit right with data on other antibody cocktails directed against Covid-19. From Eli Lilly and Regeneron to GlaxoSmithKline/Vir, antibodies have appeared much more effective when they’re deployed early. Once patients are hospitalized, the antibodies tend not to help — with Regeneron being the only exception, showing that its cocktail could reduce death for a subgroup of particularly vulnerable hospitalized patients.
So it was little surprise when Brii, too, failed to show a trend toward clinical benefit among hospitalized patients in the NIH’s ACTIV-3 trial. As such, the NIH shut down the study subgroup evaluating the program and halted enrollment early.
In ACTIV-2, the opposite happened: The data safety monitoring board sanctioned releasing the results early after reviewing around 69% of trial participants on the combined primary endpoint of hospitalizations and death.
On the safety front, Brii noted that the BRII196/BRII-198 arm actually saw fewer Grade 3 or higher adverse events than the placebo cohort in the 28 days following treatment (3.8% versus 13.4%). No drug-related serious side effects, infusion reactions or deaths were observed in either arm.
Patients from the US, Brazil, South Africa, Mexico, Argentina and the Philippines were enrolled in the trial between January and July of 2021.
“In response to the recent emergence of COVID-19 cases in China, including cases caused by the Delta variant, Brii Biosciences has cooperated with governmental agencies and hospitals in China to supply BRII-196/BRII-198 for emergency clinical use in Guangzhou, Shenzhen, Ruili, Kunming, Nanjing, Yangzhou, Zhangjiajie and Zhengzhou,” the company, which recently got listed on the Hong Kong stock exchange following a $320 million IPO raise, added in a statement.
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