Aridis Pharmaceuticals COVID mAb AR-712 Neutralizes SARS-CoV-2 Delta Variant
BY PR Newswire
— 4:05 PM ET 07/12/2021
LOS GATOS, Calif., July 12, 2021 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. ( ARDS
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) , a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, announced today that its COVID-19 mAb cocktail AR-712 binds and neutralizes the Delta variant virus SARS-CoV-2 at a highly effective level (~20ng/mL). Binding analyses project that AR-712 will be effective against all variants on the U.S. Centers for Disease Control's Variants of Interest and Variants of Concern lists.
The dual antibody cocktail will be delivered as an inhaled treatment and is expected to provide broad coverage of all known high-risk variants. In addition, Aridis is pleased to announce the preclinical development services support from NIAID (NIH) provided further demonstration of strong therapeutic efficacy of inhaled delivery in a SARS-CoV-2 hamster challenge model. This achieved reversal of disease in infected animals at an inhaled dose of 1mg/kg, equivalent to a 10mg dose in humans from a nebulizer. These results confirmed the Company's efficacy studies showing highly efficient dosing by inhalation. For reference purposes, the dose of commercially available COVID antibody therapies is currently in the range of 500mg to 1,200mg.
AR-712 is being developed as a self-administered, at-home inhaled treatment for COVID-19 patients who are not yet hospitalized. The product candidate is designed to substantially lower the barrier to treatment of COVID-19 patients and encourage treatment much earlier in the course of their disease within the patients' own homes.
The Company remains on track to finalize the Phase 1/2/3 design for this program and initiate the clinical study in 2H 2021.
About AR-712
AR-712 is a cocktail of two fully human immunoglobulin G1 (IgG1) mAbs discovered from screening the antibody secreting B-cells of convalescent SARS-CoV-2 virus infected (COVID-19) patients. These mAbs target the SARS-CoV-2 virus' receptor-binding domain (RBD) region of the spike protein at distinct, unique molecular binding sites. The binding of SARS-CoV-2 spike protein RBD by AR-712 mAbs lead to effective neutralization of the live SARS-CoV-2 viruses in all cases tested. AR-712 comprises of AR-711 and AR-720 mAbs. AR-720 mAb is higher in potency than AR-713 and thus has replaced it in the cocktail. The AR-712 mAbs are also engineered to be active for 6-12 months in the blood and formulated for effective delivery from commercially available nebulizers. Due to its direct delivery to the lungs by inhaled administration, AR-711 and AR-720 may facilitate more rapid, broader treatment coverage, and at a substantially lower dose (>100-fold lower) as compared to parenteral administration. AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge pre-clinical study. AR-720 extends the binding of SARS-CoV-2 strains to include all that are listed in the Variant of Interest and Variant of Concern by the U.S. Centers for Disease Control (CDC). Both AR-711 and AR-720 were originally discovered through a collaboration with the University of Alabama (Birmingham) and the Texas Biomedical Research Institute.
About NIAID and CoVIC Consortium
NIAID (National Institute of Allergy and Infectious Diseases) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. CoVIC is a global partnership created to accelerate discovery, optimization, and delivery of antibody-based therapeutics against SARS-CoV-2. It is an academic-industry and non-profit research collaboration that brings together scientists from around the world to study and assess which antibodies are most effective against the coronavirus SARS-CoV-2, and to streamline and accelerate the research pipeline for antibody-based therapeutics needed against SARS-CoV-2. The funders of CoVIC include the Bill & Melinda Gates Foundation, the Wellcome Trust, NIAID, and MasterCard. The company's receiving of the preclinical services support from NIAID and CoVIC should not be construed as endorsements of the company's products.
BY PR Newswire
— 4:05 PM ET 07/12/2021
LOS GATOS, Calif., July 12, 2021 /PRNewswire/ -- Aridis Pharmaceuticals, Inc. ( ARDS
Loading... Loading...
) , a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, announced today that its COVID-19 mAb cocktail AR-712 binds and neutralizes the Delta variant virus SARS-CoV-2 at a highly effective level (~20ng/mL). Binding analyses project that AR-712 will be effective against all variants on the U.S. Centers for Disease Control's Variants of Interest and Variants of Concern lists.
The dual antibody cocktail will be delivered as an inhaled treatment and is expected to provide broad coverage of all known high-risk variants. In addition, Aridis is pleased to announce the preclinical development services support from NIAID (NIH) provided further demonstration of strong therapeutic efficacy of inhaled delivery in a SARS-CoV-2 hamster challenge model. This achieved reversal of disease in infected animals at an inhaled dose of 1mg/kg, equivalent to a 10mg dose in humans from a nebulizer. These results confirmed the Company's efficacy studies showing highly efficient dosing by inhalation. For reference purposes, the dose of commercially available COVID antibody therapies is currently in the range of 500mg to 1,200mg.
AR-712 is being developed as a self-administered, at-home inhaled treatment for COVID-19 patients who are not yet hospitalized. The product candidate is designed to substantially lower the barrier to treatment of COVID-19 patients and encourage treatment much earlier in the course of their disease within the patients' own homes.
The Company remains on track to finalize the Phase 1/2/3 design for this program and initiate the clinical study in 2H 2021.
About AR-712
AR-712 is a cocktail of two fully human immunoglobulin G1 (IgG1) mAbs discovered from screening the antibody secreting B-cells of convalescent SARS-CoV-2 virus infected (COVID-19) patients. These mAbs target the SARS-CoV-2 virus' receptor-binding domain (RBD) region of the spike protein at distinct, unique molecular binding sites. The binding of SARS-CoV-2 spike protein RBD by AR-712 mAbs lead to effective neutralization of the live SARS-CoV-2 viruses in all cases tested. AR-712 comprises of AR-711 and AR-720 mAbs. AR-720 mAb is higher in potency than AR-713 and thus has replaced it in the cocktail. The AR-712 mAbs are also engineered to be active for 6-12 months in the blood and formulated for effective delivery from commercially available nebulizers. Due to its direct delivery to the lungs by inhaled administration, AR-711 and AR-720 may facilitate more rapid, broader treatment coverage, and at a substantially lower dose (>100-fold lower) as compared to parenteral administration. AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge pre-clinical study. AR-720 extends the binding of SARS-CoV-2 strains to include all that are listed in the Variant of Interest and Variant of Concern by the U.S. Centers for Disease Control (CDC). Both AR-711 and AR-720 were originally discovered through a collaboration with the University of Alabama (Birmingham) and the Texas Biomedical Research Institute.
About NIAID and CoVIC Consortium
NIAID (National Institute of Allergy and Infectious Diseases) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. CoVIC is a global partnership created to accelerate discovery, optimization, and delivery of antibody-based therapeutics against SARS-CoV-2. It is an academic-industry and non-profit research collaboration that brings together scientists from around the world to study and assess which antibodies are most effective against the coronavirus SARS-CoV-2, and to streamline and accelerate the research pipeline for antibody-based therapeutics needed against SARS-CoV-2. The funders of CoVIC include the Bill & Melinda Gates Foundation, the Wellcome Trust, NIAID, and MasterCard. The company's receiving of the preclinical services support from NIAID and CoVIC should not be construed as endorsements of the company's products.
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