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Aridis announces planned clinical development of inhaled mAb cocktail for COVID-19

Aridis Pharmaceuticals announced that it is now receiving preclinical support from the NIAID (National Institute of Allergy and Infectious Diseases) and CoVIC (Coronavirus Immunotherapy Consortium) for a nebulized monoclonal antibody cocktail for COVID-19 and that it plans to initiate a Phase 1/2/3 clinical trial in the second half of this year. The company also said that it has added its AR-713 mAb, which is intended to neutralize new variants of SARS-CoV-2, to its AR-711 mAb, which was already in development as an at-home inhaled treatment for COVID-19 patients early in the course of the disease. The resulting mAb cocktail is known as AR-712.

According to Aridis, in vitro testing has demonstrated that AR-713 has the ability to neutralize variants with the E484K mutation, including the Brazilian, Japanese, and South African variants. With the addition of the second mAb, the company said, the inhaled therapy should neutralize the original strain of the virus as well as all of the variants that are known to be high risk at this time. Both of the mAbs in the cocktail “are fully human immunoglobulin G1 (IgG1) mAbs discovered from screening the antibody secreting B-cells of convalescent SARS-CoV-2 virus infected (COVID-19) patients.”

Aridis Pharmaceuticals CEO Vu Truong said, “As the COVID-19 pandemic spreads globally, the virus continues to mutate into variants which render the majority of the available vaccines and mAbs less effective. Scientists at Aridis continue to collaborate with multiple global research organizations in their ongoing search for the best agents to target this rapidly-changing virus. We are committed to being nimble and adjust our treatment, as needed, in order to keep pace with the virus as it continues to evolve. The addition of AR-713 follows this strategy of rapid responsiveness.”

Truong added, “Even at peak COVID-19 vaccination coverage, it is expected that up to a third of the world’s population will remain unvaccinated and at risk of contracting COVID-19, thus requiring treatment intervention. This is exactly where treatment modalities such as our inhaled COVID-19 mAb cocktail could fill the gap, i.e. by neutralizing the circulating and variant viral strains allowing infected individuals to be treated earlier and recover at home. We are pleased to deliver a second mAb to provide broad coverage including the newly emerging COVID-19 strains. We are also thankful to our collaborators at NIAID/CoVIC whose lab work is helping us complete our FDA and EMA dossiers for an expeditious start of the Phase 1/2/3 clinical trials.”

The company’s pipeline also includes a nebulized formulation of gallium citrate for the treatment of lung infections in cystic fibrosis patients.

Read the Aridis Pharmaceuticals press release.

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published on February 23, 2021

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