|Aridis Pharmaceuticals Provides Multiple Program Updates Including the Addition of a Second Inhaled Antibody to Neutralize Newly Emerging COVID-19 Mutated Variants|
|By: PR Newswire Association LLC. - 23 Feb 2021||Back to overview list
LOS GATOS, Calif., Feb. 23, 2021 /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, announced today that it has augmented its inhaled AR-711 monoclonal antibody (mAb) to COVID-19 with a second mAb (AR-713) that is designed to neutralize newly emerging COVID-19 mutated variants including those from South Africa, Brazil and Japan. Together, the enhanced dual antibody cocktail will be delivered as an inhaled treatment and is expected to provide broad coverage of all known high-risk strains. In addition, Aridis is pleased to announce preclinical development services support from NIAID. The preclinical development services support is also provided by the Coronavirus Immunotherapy Consortium (CoVIC). Aridis is on track to initiate the program's Phase 1/2/3 clinical trial in 2H 2021.
AR-711 is being developed as a self-administered, at-home inhaled treatment for COVID-19 patients who are not yet hospitalized. The Company's vision is that if highly effective immunotherapies such as mAbs could be formulated as inhaled therapy, then COVID-19 patients could be treated much earlier in the course of their disease within their own homes. This could offer convenience to patients and reduce pressure on medical infrastructure, including outpatient infusion centers and hospitals. As the pandemic evolves, new mutant and more contagious strains of the SARS-CoV-2 virus have emerged, rendering most available vaccines and monoclonal antibodies less effective. In response, the Company is now adding a second mAb AR-713, which has been shown to completely neutralize in vitro the 'E484K' mutation containing SARS-CoV-2 variant, associated with the Brazilian and Japanese variants (P.1) and the South African variant (B.1.351). This enhanced cocktail is designed to neutralize these variants as well as the original strain, the D614G strain, and the UK strain (B.1.1.7), providing broad coverage of all currently known high-risk strains.
"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," commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals. "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."
"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," continued Truong. "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 remains on track to finalize the Phase 1/2/3 design for this program and obtain concurrence from the FDA and EMA in 1H 2021 such that patient enrollment can be initiated in 2H 2021.
About AR-711 and AR-713
About NIAID and CoVIC Consortium
About Aridis Pharmaceuticals, Inc.
The Company has generated multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia (VAP) and hospital acquired pneumonia (HAP), in addition to preclinical stage antiviral mAbs. The use of mAbs as anti-infective treatments represents an innovative therapeutic approach that harnesses the human immune system to fight infections and is designed to overcome the deficiencies associated with the current standard of care which is broad spectrum antibiotics. Such deficiencies include, but are not limited to, increasing drug resistance, short duration of efficacy, disruption of the normal flora of the human microbiome and lack of differentiation among current treatments. The mAb portfolio is complemented by a non-antibiotic novel mechanism small molecule anti-infective candidate being developed to treat lung infections in cystic fibrosis patients. The Company's pipeline is highlighted below:
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 Phase 2a clinical development in CF patients.
AR-401 (blood stream infections). AR-401 is a fully human mAb preclinical program aimed at treating infections caused by gram-negative Acinetobacter baumannii.
AR-701 (COVID-19). AR-701 is a cocktail of fully human mAbs discovered from convalescent COVID-19 patients that are directed at multiple envelope proteins of the SARS-CoV-2 virus.
AR-712 (COVID-19). AR-712 is a cocktail of fully human mAbs (AR-711 and AR-713) that are directed against the receptor binding domain of the SARS-CoV-2 virus. It is formulated for delivery via inhalation using a nebulizer.
AR-201 (RSV infection). AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV).
For additional information on Aridis Pharmaceuticals, please visit https://aridispharma.com/.
View original content to download multimedia:http://www.prnewswire.com/news-releases/aridis-pharmaceuticals-provides-multiple-program-updates-including-the-addition-of-a-second-inhaled-antibody-to-neutralize-newly-emerging-covid-19-mutated-variants-301233171.html
SOURCE Aridis Pharmaceuticals, Inc.
Copyright 2021 PR Newswire Association LLC.
|Back to overview list|