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First in Human: Early-stage COVID therapies hold promise against omicron variant

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This is a recurring column on clinical research in the early stages of development, which is referred to as phase 1. These are treatments being used for the first time in a small number of human patients to determine safety, dosing and general pharmacological activity.

Early-stage studies of COVID-19 treatments from the likes of Vir Biotechnology Inc. and Trevena Inc. could offer potential new weapons against omicron and future viral variants.

The omicron strain of the virus was first identified in South Africa in early November, and an existing treatment has already shown positive results in the lab. While vaccine-makers race to test their shots against the variant, the monoclonal antibody sotrovimab from Vir and partner GlaxoSmithKline PLC posted results Dec. 7 demonstrating activity against the omicron spike protein.

Sotrovimab is the first monoclonal antibody showing preclinical efficacy against all COVID-19 variants, including the delta and omicron mutations, Vir CEO George Scangos said on a Dec. 7 call with analysts.

"Sotrovimab is deliberately designed with the mutating virus in mind," Scangos said. "By targeting a highly conserved region of the spike protein that is less likely to mutate, we hope to address both the current SARS-CoV-2 virus and future variants that we expected would inevitably arise."

The treatment is already authorized for emergency use in the U.S. and EU following separate phase 2 and 3 trials in patients infected with the original strain of the COVID-19 virus. Vir and GSK have committed to 700,000 doses for purchase in 2021 with contracts worth about $1 billion, and Scangos said the companies expect to deliver a further 2 million doses in 2022.

The drugmakers also have another monoclonal antibody in phase 1b/2a trials called VIR-7832, and Vir said it too has shown an ability to neutralize SARS-CoV-2 in the lab. In patients with mild to moderate infections, VIR-7832 will be tested simultaneously for safety and in comparison with sotrovimab.

This new antibody recognizes the same epitope the part of an antigen molecule that an antibody attaches itself to as sotrovimab, and it also retains activity against the omicron variant, Scangos said. "So it says remains a very interesting antibody, which has ... potentially the ability to be more potent in the short term and induce cell response in the long term," the CEO added.

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Trevena targets lung damage and clotting

The COVID-19 pandemic will not be halted by just one or two major vaccines and therapies but will require a trove of scientific solutions that respond to a changing virus, Trevena Chief Medical Officer Mark Demitrack told S&P Global Market Intelligence.

"Overcoming this global pandemic will take a multi-pronged approach, including vaccines, public health measures and symptomatic treatment options," Demitrack said.

The Chesterbrook, Pa.-based biotech's compound TRV027 works differently than Vir's, Demitrack explained. Rather than neutralizing the virus itself, the early-stage drug — from a class called AT1 receptor selective agonists has the potential to treat both lung damage and abnormal clotting that can lead to severe disease and death of hospitalized COVID-19 patients.

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Trevena Chief Medical Officer Mark Demitrack
Source: Trevena

Because TRV027 does not act on the spike proteins of the virus, its effectiveness against the omicron variant would theoretically be no different than on other mutations.

"While the global healthcare community has made monumental strides over the past 18 months, the rise of the delta and omicron variants certainly underscore the continued need for effective therapeutic options for hospitalized COVID-19 patients, particularly in the acute inpatient setting," Demitrack said.

A study of the drug is part of the U.S. National Institutes of Health's ACTIV initiative to fast-track the testing of certain COVID-19 therapies and vaccines, as well as the similar REMAP-CAP program in the U.K. Results from Trevena's study are expected as early as mid-2022, Demitrack said.

For the central nervous system-focused company whose only U.S.-approved treatment is the Olinvyk injection for acute pain the journey to first-in-human trials began with a hypothesis posed by two of Trevena's scientific founders and a proof-of-concept study showing the compound worked to quell the most deadly symptoms of COVID-19.

"We believe these findings provide encouraging early evidence that TRV027 may help hospitalized COVID-19 patients early on in the course of their illness," Demitrack said.