Salvecin (tosatoxumab) / Aridis - LARVOL DELTA

Exploring Human Use of Monoclonal Antibodies Against Critical Bacteria: A Scoping Review of Clinical Trials. (PubMed, Infect Dis Ther) - "Inconsistent efficacy may stem from complex host-pathogen interactions, biofilm formation, and variations in patient immune status. Future trials should investigate early mAb administration, stratified patient selection, and standardized antibiotic coadministration, poorly addressed thus far. Optimized dosing and mAb combination regimens are promising yet unexplored paths, while high production costs and regulatory issues remain a significant barrier."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases

Aridis Receives Agreement from the European Medicines Agency (EMA) on the Clinical Study Design and a Single Confirmatory Phase 3 Study of AR-301 (GlobeNewswire) - "Aridis Pharmaceuticals...today announced positive feedback from the European Medicines Agency (EMA) on the Company’s proposed single confirmatory Phase 3 study of investigational monoclonal antibody candidate AR-301...Agreement on the design of the single confirmatory Phase 3 superiority study required to support the submission of a Marketing Authorization Application (MAA) with the primary efficacy endpoint in older adults (≥65 yrs)....In the first Phase 3 study ‘AR-301-002’, the magnitude of absolute efficacy was higher in older adults, i.e., +34% improvement on Day 21 (p= 0.057) and by +38% on Day 28 (p= 0.025) in older adults versus +11% improvement (p=0.24) in the overall population."

European regulatory • Pneumonia

AR-301-002: Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301 (clinicaltrials.gov) - P3 | N=174 | Completed | Sponsor: Aridis Pharmaceuticals, Inc. | Recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Oct 2022 | Trial primary completion date: Jul 2022 ➔ Oct 2022

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pneumonia • Respiratory Diseases

"Efficacy and safety profile of #tosatoxumab (AR-301) anti-Staphylococcus aureus mAb. #ECCMID2023" (@LordAlirezaF)

Clinical

Efficacy and safety profile of tosatoxumab (AR-301), a novel anti-Staphylococcus aureus monoclonal antibody (mAb): results of the phase 3 AR-301-002 (ASAP) study of adjunctive treatment of S. aureus ventilator-associated pneumonia (VAP) in mechanically ventilated, intensive care unit (ICU) patients (ECCMID 2023) - No abstract available

Clinical • Late-breaking abstract • P3 data • Critical care • Infectious Disease • Pneumonia • Respiratory Diseases

AR-301-002: Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301 (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Aridis Pharmaceuticals, Inc. | Trial completion date: Aug 2020 ➔ Jul 2022 | Trial primary completion date: Aug 2020 ➔ Jul 2022

Trial completion date • Trial primary completion date • Infectious Disease • Pneumonia • Respiratory Diseases

Aridis Pharmaceuticals Announces First Quarter 2021 Results (PRNewswire) - "The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering. A clinical Phase 1/2 study is expected to be launched in 2H 2021....AR-301 is being evaluated in a Phase 3 clinical study as an adjunctive treatment to standard of care antibiotics in S. aureus infected ventilator associated pneumonia (VAP) patients....The Phase 3 interim futility analysis from the ongoing pivotal trial is now expected to be reported in 2H 2021 and top line data by 1H 2022."

New P1/2 trial • P3 data: top line • Infectious Disease • Novel Coronavirus Disease

Aridis Pharmaceuticals to Host Fireside Chat with Analysts to Discuss 2021 Outlook for its Lead Programs and Novel mAb Discovery Platform on December 4th, 2020 (PRNewswire) - "Aridis Pharmaceuticals, Inc....is pleased to announce a 75 minute 'Fireside Chat Forum,' with its five covering analysts will be held on December 4th, 2020 at 11:00AM EST....AR-301: Currently enrolling a Phase 3 global clinical trial in patients with ventilator associated pneumonia (VAP)...for COVID-19. Interim data expected in 1H 2021; full data in YE 2021; COVID-19 (AR-711 & 701): Developing inhaled, self-administered, at-home treatment for mild-to-moderate condition (AR-711). A clinical Phase 1/2 study to be launched in 1H 2021. Continuing characterization of monoclonal antibody cocktail (AR-701) for intravenous inpatient treatment for moderate-severe indications."

Enrollment status • New P1/2 trial • P3 data • P3 data: top line • Infectious Disease • Novel Coronavirus Disease

Aridis Pharmaceuticals Announces $8.5 Million Registered Direct Offering (PRNewswire) - "The Company intends to use the net proceeds from the registered direct offering and concurrent private placement for clinical development of its product candidates, working capital and other general corporate purposes. In the near-term, priority will be placed on the Company's ongoing AR-301 Phase 3 clinical trial for patients with ventilator associated pneumonia (VAP), AR-501's Phase 2b clinical trial for the treatment of chronic lung infections in cystic fibrosis patients, and to continue developing novel COVID-19 therapies."

Financing • Cystic Fibrosis

Aridis Pharmaceuticals enrolls its first Covid-19 patient in ongoing phase 3 AR-301 clinical trial in Ventilator Associated Pneumonia (VAP) (BioSpace) - "Aridis Pharmaceuticals, Inc....announced today the enrollment of its first COVID-19 patient in the Company's ongoing Phase 3 clinical trial of AR-301, a monoclonal antibody...in patients who were already on mechanical ventilators....The AR-301 Phase 3 clinical study was initiated in the first quarter of 2019 and is expected to enroll 240 patients at approximately 160 clinical centers in 22 countries. The trial represents the first ever Phase 3 superiority clinical study evaluating immunotherapy with a fully human monoclonal antibody to treat acute S. aureus bacterial pneumonia in mechanically ventilated ICU patients."

Enrollment open • New P3 trial • Infectious Disease • Novel Coronavirus Disease