Aridis Receives Agreement from the European Medicines Agency (EMA) on the Clinical Study Design and a Single Confirmatory Phase 3 Study of AR-301 - Seite 2

About AR-301
AR-301 is a fully human IgG1 monoclonal antibody that specifically targets S. aureus alpha-toxin, an important virulence factor that is secreted by both methicillin-resistant S aureus (MRSA) and methicillin-susceptible S. aureus (MSSA). AR-301 is designed to protect against alpha-toxin mediated destruction of host cells, preserving a functional host immune response. AR-301’s mode of action is independent of the antibiotic resistance profile of S. aureus and it is active against infections caused by both MRSA and MSSA. Previously in the AR-301-002 Phase 3 superiority study, an improvement trend in absolute efficacy in Clinical Cure rate at Day 21 of 11.2%, [p= 0.24] was observed in treated patients as compared to placebo. An improvement in Clinical Cure rate (or absolute efficacy) ≥10% is considered a clinically meaningful improvement by many key opinion leaders. In the prespecified older adult population of 65+ years, the absolute efficacy on Day 21 was increased to 33.6% (p= 0.057), and to 37.9% (p= 0.025) on Day 28. The increase in absolute efficacy was particularly remarkable given the lower efficacy of SOC antibiotics in older adults 65+ years old compared to adults ≤65 years old (30% vs. 75%, respectively). In the patients with MRSA, the Day 21 absolute efficacy trend was 28% higher than SOC alone (p=0.831). The increase in absolute efficacy was also driven primarily by the lower efficacy of SOC antibiotics in MRSA patients compared MSSA patients (38% vs. 63%, respectively). Furthermore, treatment with AR-301 was associated with reduction trends in key secondary outcome measures of duration of hospitalization (median 19 vs. 28 days, difference: 9 days), time in ICU (median 13 vs. 20 days, difference: 7 days) and mechanical ventilation days (median 6 vs. 8 days, difference: 2 days). Consistent positive efficacy trends were observed in favor of AR-301 treatment in other key secondary efficacy outcomes (e.g., Clinical Cure rates at days 7, 14, 28).

Primary outcome measures of safety and tolerability of AR-301 were achieved. AR-301 intravenous (IV) infusion was well tolerated. No meaningful differences were observed in adverse Events (AEs) and Serious Adverse Events (SAEs) reported between the active and placebo treatment groups over the 28-day study period, with no SAEs deemed drug-related.

Staphylococcus aureus Ventilator Associated Pneumonia (VAP), Hospital Acquired Pneumonia (HAP), and Community Acquired Pneumonia (CAP)