Brii Bio joins the NIH graveyard alongside GSK, Lilly after flopping antibody study in hospitalized Covid-19 patients
Just a day after GlaxoSmithKline and Vir Biotechnology’s Covid-19 antibody fell flat in an NIH-sponsored trial for hospitalized patients, researchers have ejected another therapy from the study. Is this the death knell for monoclonal antibodies for those patients?
An antibody cocktail from Brii Biosciences failed to show a trend toward clinical benefit in the NIH’s ACTIV-3 trial, and as a result, did not meet criteria for further enrollment. As such, the NIH shut down the study subgroup evaluating the program Thursday, which contains the two Brii antibodies dubbed BRII-196 and BRII-198.
Researchers had recruited 343 volunteers out of a goal of 450 into the Brii subgroup of ACTIV-3, and they will continue to be followed for 18 months. Patients were randomized to receive either a saline placebo or Brii’s combo on top of the standard of care — in this case, Gilead’s Veklury therapy, also known as remdesivir.
After five days, the NIH assessed the participants’ conditions using two seven-point scales, which described their conditions ranging from being able to undertake usual activities with minimal or no symptoms, to death. Thursday’s news came after a pre-planned interim analysis looking at both safety and efficacy.
The NIH found no safety issues with the Brii cocktail, and more data are expected to be released once investigators finish analyzing the results. The therapy will continue to be evaluated in the ACTIV-2 trial, measuring the effectiveness in mild to moderate Covid-19 cases for those who don’t need to be hospitalized.
It’s a setback for the biotech based in China and North Carolina, after it had partnered with researchers behind a paper released early in the pandemic showing some of the first monoclonal antibody activity against SARS-CoV-2. CEO Zhi Hong had aimed to pair their wet lab capabilities and access to patients with his biotech’s development, antibody optimization and regulatory expertise.
But now Brii has followed the same path as Eli Lilly and the GSK/Vir duo, with their antibody therapies striking out in hospitalized patients. Lilly’s antibody LY-CoV555 flopped in the ACTIV-3 protocol in hospitalized patients back in October, while GSK and Vir saw their subgroup shut down after investigators raised concerns about a potential benefit, the pair said Wednesday.
Currently, the only investigational therapy still being evaluated in the ACTIV-3 trial is AstraZeneca’s AZD7442 cocktail, which former President Donald Trump’s HHS funded last October for $486 million. And Veklury remains the only therapy specifically authorized to treat patients hospitalized with Covid-19, with the steroid dexamethasone widely used in more severe patients. Lilly and Regeneron have both picked up EUAs for antibody therapies in non-hospitalized settings.
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