- Vir Biotechnology and GlaxoSmithKline said Monday they have initiated the first human trial of their experimental coronavirus antibody drug, a Phase 2/3 study aiming to keep the disease from worsening in patients with mild or moderate COVID-19 symptoms.
- Vir and GSK moved their the drug straight into a mid-stage trial that will begin with a "lead in" phase testing the safety of the therapy in a small group of non-hospitalized patients, followed by an "expansion" phase judging the treatment's effectiveness in a wider range of volunteers. In separate trials, Vir and GSK also plan to test the drug in severely ill, hospitalized patients as well as for prevention of infection.
- The drug, called VIR-7831, is the fourth antibody medicine to enter human testing, with the aim of providing a treatment or prevention option before, or as, mass vaccination programs take off in the coming months. Regeneron, Eli Lilly and AstraZeneca have already done so, although some of the trials have struggled to make progress.
Tagged as a mid- to late-stage study, the COMET-ICE trial of VIR-7831 has two phases. The first will test how safe and tolerable it is over 14 days, with 20 non-hospitalized COVID-19 patients in the U.S. randomized to receive an infusion of 500 milligrams of the antibody or a placebo. If the drug is found to be safe, the companies will enroll 1,300 more patients around the globe, aiming to see whether it can outperform a placebo in preventing hospitalization or death within 29 days.
These engineered antibodies mimic the effects of the infection-fighting molecules our bodies produce to fight off a pathogen. They are, effectively, a more precise, more easily mass-produced version of convalescent plasma, the antibody-rich treatment the Food and Drug Administration controversially cleared for emergency use in COVID-19 last week.
Convalescent plasma as a treatment is limited by the number of donor patients and the ability of healthcare institutions to process and deliver it. Its effects are also variable, depending on the level of neutralizing antibodies in the donor's sample. An engineered antibody, on the other hand, would face fewer limitations, and could theoretically be used both to treat and prevent coronavirus infections.
The approach has drawn the interest of multiple drugmakers, with Regeneron and Eli Lilly leading the way and AstraZeneca recently joining them in human testing. Several more could follow in the coming months, including Amgen, AbbVie and startup Adagio Therapeutics.
Early in the pandemic, some analysts believed that engineered antibodies could play a broad role in mitigating the effects of the pandemic by limiting infections, hospitalizations and deaths. But with coronavirus vaccines advancing quickly, and antibodies failing to get the same level of financial support from governments, the role of engineered antibodies could be more limited. They could emerge only as a treatment for sick patients, rather than a preventive medication, particularly if they get to market around the same time the first vaccines do, which looks possible.
Nonetheless, Vir is planning a trial of VIR-7831, also called GSK4182136, in a preventive setting. Moreover, the partners say a second experimental drug due to enter a Phase 2 trial later this year, called VIR-7832, could serve as a "therapeutic and/or prophylactic T cell vaccine."
GSK and Vir are taking a different strategic approach than their rivals. They are developing single engineered antibodies, which are less complex to make than a combination, but are modifying them to make their effects last longer. Regeneron, by comparison, is advancing a cocktail of drugs. AstraZeneca is as well, but like Vir, is tweaking them.
GSK and Vir agreed to partner on coronavirus antibody treatments in April after the British big pharma invested $250 million in the California-based biotech.