Brii's COVID-19 antibody cocktail remains active against variants, expects Q4 data readout

Brii Biosciences sees a light at the end of the tunnel for the COVID-19 pandemic with hopes that its antibody cocktail will stave off quickly spreading variants in ambulatory care patients. 

The monoclonal antibody combination therapy, BRII-196 and BRII-198, was given the phase 3 green light in late April after the National Institutes of Health (NIH) shuttered a study of hospitalized patients in March. 

"Our antibody cocktail remains active against most of the major variants of the virus: Delta, Beta, those key variants," said Rogers Luo, president and general manager of Greater China for Brii. The phase 3 trial is ongoing and still recruiting patients in South Africa, Brazil, Argentina, U.S. and likely to enter India, as well, Luo said. 

RELATED: Brii's COVID antibody combo cleared for phase 3 as it targets high-risk patients to head off hospitalization

Brii expects a phase 3 data readout in the fourth quarter of this year, Luo said. The biotech, with offices in China and the U.S., is also working on a phase 2 study of the treatment in China, where there have been some outbreaks in the southern region. Brii had finished a phase 1 trial last year but there were few COVID-19 patients, but with small outbreaks re-emerging, the company went forward with another study, Luo said.

It is not, however, a one-trick pony and the COVID antibody cocktail is just one of many treatments Brii is focused on, with a large chunk of its public offering on Tuesday going toward a Hepatitis-B (HBV) program. Brii is hoping Luo can replicate his success of bringing eight drugs to market in China while leading operations in the region for Gilead from 2016 to 2020. 

RELATED: Brii hires Gilead's China general manager Luo to drive expansion

About 50% of the proceeds from a 2.48 billion Hong Kong dollars ($319 million) listing in Hong Kong this week will go toward Brii's HBV programs, Luo said. China and other Asian countries have a high prevalence of HBV, though there are 87 million people who are chronic carriers of the hepatitis B virus in China, accounting for about one-third of all hepatitis B virus chronic carriers in the world, according to the World Health Organization (WHO).

Brii and licensing partners Vir Biotechnology and VBI Vaccines dosed the first patient in a phase 2 trial of a combination HBV treatment in April, with more data expected by year's end, Luo said. The trial, comparing BRII-835 to the combination of BRII-835 and BRII-179, is being conducted at sites across Asia-Pacific and Australia. Brii has Greater China rights, and its partners have exclusivity in the rest of the world. 

Listing on the Hong Kong exchange also fuels Brii's work on HIV. Brii has dosed the first cohort of its phase 1 trial of BRII-732, a once-weekly oral treatment, and in March also began a phase 1 trial of another once-weekly oral HIV treatment, BRII-778. Top-line results for both are slated for later this year or early next year, the company has said.

RELATED: GSK's long-acting HIV injectable, Cabenuva, finally snags its FDA green light

Long-acting treatments for HIV are a recent trend, Luo said, noting the recent green light of GlaxoSmithKline’s ViiV Healthcare's long-acting HIV injectable. The FDA approved Cabenuva in January. And, Luo's former employer, Gilead, filed late last month for approval of its own long-acting HIV treatment.

“There’s a trend, more patients will switch to the long-acting choice. More players in this market benefits patients definitely," Luo said. 

Further yet, Brii has a phase 1 trial for BRII-296, which is being tested in patients with post-partum depression. The biotech expects top-line results by the end of this year, and Brii is also working on developing the drug for major depressive disorder.