Pharma Focus Europe

Aridis Pharmaceuticals Granted FDA Agreement for Single Confirmatory Phase 3 Study of AR-301 and Reveals Clinical Study Design

Saturday, July 01, 2023

Aridis Pharmaceuticals, Inc. (Nasdaq: ARDS) has received positive feedback from the FDA regarding its proposed Phase 3 study for investigational monoclonal antibody candidate AR-301. The study aims to evaluate the antibody as an adjunctive therapy, in combination with standard of care antibiotics, for the treatment of pneumonia caused by Gram-positive bacteria Staphylococcus aureus (S. aureus) in mechanically ventilated hospitalized patients.

The FDA has agreed on the design of the single confirmatory Phase 3 superiority study, which is required to support the submission of a Biologics License Application (BLA). The agency has also agreed to the expansion of the study to include ventilated hospital-acquired pneumonia (HAP) and ventilated community-acquired pneumonia (CAP) patients, in addition to ventilator-associated pneumonia (VAP) patients.

The primary efficacy endpoint of the study will be the same as the previous Phase 3 trial (AR-301-002), which is the clinical cure of pneumonia on Day 21. However, the primary efficacy endpoint for the confirmatory Phase 3 study will focus specifically on older adults aged 65 and above. This decision is based on the higher efficacy observed in older adults in the previous trial compared to the overall population.

The confirmatory Phase 3 study (AR-301-003) will be powered to assess efficacy in both the primary efficacy endpoint in adults aged 65 and above, as well as the key secondary efficacy endpoint in all study subjects (both above and below 65 years of age).

Aridis Pharmaceuticals' CEO, Vu Truong, expressed satisfaction with the FDA's agreement on the study design, endpoints, and patient populations. The company believes that this regulatory pathway will facilitate the availability of AR-301 to patients with high unmet medical needs and increase the potential for partnerships with pharmaceutical companies.

AR-301 is a fully human monoclonal antibody that targets S. aureus alpha-toxin, a virulence factor secreted by methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA). The antibody is designed to protect host cells from the destructive effects of alpha-toxin and preserve a functional immune response. In the previous Phase 3 study, AR-301 demonstrated a trend of improvement in the clinical cure rate of pneumonia compared to placebo.

Pneumonia caused by S. aureus, including VAP, HAP, and CAP, poses significant challenges in the hospital setting due to the inadequacy of standard antibiotics and the rise of antibiotic resistance. These infections are associated with high mortality rates and prolonged hospital stays in ICUs, leading to a substantial economic burden.

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