By NewsDesk @bactiman63
Aridis Pharmaceuticals, Inc., 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.
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