SAN JOSE, Calif. /PRNewswire/ -- Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies to treat life-threatening infections, today announced the development of a highly neutralizing monoclonal antibody AR-711, discovered from convalescent COVID-19 patients, that successfully eliminated all detectable SARS-CoV-2 virus in infected animals at substantially lower doses than parenterally administered (injected) COVID-19 monoclonal antibodies (“mAb”). The potency of AR-711 and its direct delivery to the lungs by inhaled administration may facilitate broader treatment coverage and dose sparing not achievable by parenteral administration.

• AR-711 is directed against the conserved receptor-binding domain (RBD) region of the original SARS-CoV2 virus and its newly emerging variants including the currently prevalent strain G614.  
• AR-711 is engineered to be long-acting in blood for up to six to 12 months.
• In the animal challenge study, golden Syrian hamsters were pre-infected with SARS-CoV-2 before a single inhalation exposure of AR-711 liquid aerosols. AR-711 eliminated detectable SARS-CoV-2 virus at all dose levels tested, with the lowest lung deposited dose of 0.03 mg/kg. The detailed data is now available on BioXriv [https://www.biorxiv.org/content/10.1101/2020.10.14.339150v1].
• AR-711 is stabilized using a proprietary formulation designed to protect the mAb from the physical stresses imparted by commercial nebulizer delivery devices on protein drugs. 
• An inhalable treatment that can be self-administered using a wide variety of commercially available nebulizers can facilitate broader coverage in non-hospitalized settings and at a scale not achievable using conventional inpatient IV infusion treatments.

“As we expected, combining a highly potent monoclonal antibody with direct delivery to the lungs, which is the main target of the COVID-19 virus, achieved impressive efficacy in these animal models. The therapeutic dose that we observed corresponds to an estimated adult human equivalent efficacious inhaled dose of 2 to 6 milligrams (mg) per dose. This compares very favorably to other clinical stage COVID-19 mAbs, where up to 8,000 mg are being studied to achieve clinical benefit,” said Hasan Jafri, M.D., Chief Medical Offer of Aridis.   

“Over 90% COVID-19 symptomatic patients are home bound, under quarantine, and often not treated. While these patients wait, their health can deteriorate, and they could infect those around them. Having a convenient way to self-medicate with the simplicity of an asthma inhaler where the drug is delivered directly to the infection site can have a transformative impact on patients’ lives, expand treatment coverage, and ultimately reduce global transmissibility,” said Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. 

“Given the attractive human safety data of anti-infective mAbs and our strong preclinical efficacy as a therapeutic treatment, we plan to evaluate the therapeutic treatment using AR-711 in non-hospitalized mild to moderate COVID-19 patients in a global study to be launched in the first half of next year,” said Dr. Jafri.     

“The exceedingly low drug dose that achieved therapeutic efficacy is particularly exciting, as it provides a unique opportunity to meaningfully reduce treatment costs and hospitalization burden at a potential magnitude not previously achievable with mAb therapies. We are excited to bring an entirely new treatment paradigm to the COVID-19 fight,” commented Vu Truong.

About AR-711

AR-711 is a fully human immunoglobulin 1, or IgG1, monoclonal antibody discovered from screening the antibody secreting B-cells of convalescent COVID-19 patients. AR-711 exhibits high affinity for SARS-CoV-2 spike protein, approximately 10-fold or higher than mAb candidates currently in late stage clinical testing. AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge study. AR-711 was discovered at the University of Alabama at Birmingham and Texas Biomedical Research Institute (originally known as mAb ‘1212C2’), recently licensed and is currently being developed by Aridis as an inhaled, self-administered treatment for non-hospitalized patients suffering from mild to moderate COVID-19. AR-711 is also one the two mAbs in the company’s AR-701 mAb cocktail, which is a separate program being developed as an intravenous treatment of moderate to severe, hospitalized COVID-19 patients.

About ʎPEX^TM Technology Platform

Aridis utilizes its ʎPEX technology platform for the unbiased discovery of new and highly potent antibodies against pathogens including COVID-19. The ʎPEX platform is comprised of a silicon wafer-based array of nanoliter sized tissue micro-culture wells that enable rapid screening of antibody secreting cells, enabling discovery of potent antibodies against targets such as SARS-CoV-2, the virus that causes COVID-19 disease within a few days of patient sample availability. It also features CRISPR enabled activation of endogenous genetic control elements that dramatically increase the yield of such therapeutic antibodies from manufacturing production cell lines. The technology also features a proprietary production cell line that is designed to rapidly manufacture multiple monoclonal antibody therapeutics at approximately half the manufacturing cycle time than currently available manufacturing technologies. 

Aridis' Pipeline

AR-301 (VAP). AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus (S. aureus) alpha-toxin in VAP patients.

AR-101 (HAP). AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa (P. aeruginosa) liposaccharides serotype O11, which accounts for approximately 22% of all P. aeruginosa hospital acquired pneumonia cases worldwide. 

AR-501 (cystic fibrosis). AR-501 is an inhaled formulation of gallium citrate with broad-spectrum anti-infective activity being developed to treat chronic lung infections in cystic fibrosis patients.  This program is currently in a Phase 1/2a clinical study in healthy volunteers and CF patients.