Brii Bio shelves once-promising COVID antibody combo that stood up to variants

By choosing antibodies from the plasma of a wide range of recovered COVID-19 patients, Brii Biosciences hoped to score big with a treatment that would stand up to coronavirus variants.

But the brief commercial run of BRII-196/198, a long-acting combination of amubarvimab and romlusevimab, is over, the company said on Friday. Brii will stop manufacturing the cocktail in China and has pulled its submission for emergency use authorization in the United States.

“This determination is based on constantly evolving COVID-19 trends and policy updates as well as protracted regulatory inspections at our contract development and manufacturing organization (CDMO) sites,” the company explained.

Brii, which was launched in 2018 and is based in Beijing and Durham, North Carolina, made news in December of 2021 when it became the first COVID-19 antibody combo approved in China. 

The biotech rolled out the combo in July of last year but reported sales of just 51.6 million Chinese yuan ($7.5 million) for last year. BRII-196/198 reached 358 hospitals in 25 provinces, the company said.

Ditching BRII-196/198 allows the company to redirect resources to its “high-priority programs,” it said.

Those include prospects for hepatitis B viral (HBV) infection, postpartum depression (PPD) and major depressive disorders (MDD).

Also in Brii’s pipeline are candidates for human immunodeficiency virus (HIV), multidrug-resistant (MDR) and extensively drug-resistant (XDR) Gram-negative infections and non-tuberculous mycobacterial (NTM) lung disease.

Brii’s COVID combo once held great promise, compelling SVB Leerink analyst Geoffrey Porges to project $1.3 billion in stockpile orders from the U.S. and China in October of 2021.

That estimate came after a National Institutes of Health-run phase 3 trial of BRII-196/198 significantly reduced hospitalization and death over placebo in non-hospitalized patients. It also showed similar efficacy when administered up to 10 days after symptom onset as opposed to small molecule treatments which were designed to be taken within five days.