Regulatory Aridis receives FDA agreement on single Phase 3 study...

Aridis receives FDA agreement on single Phase 3 study for AR-301


Aridis Pharmaceuticals, Inc. received encouraging FDA feedback on their planned Phase 3 study for AR-301, a monoclonal antibody being developed as an additional treatment, alongside standard antibiotics, for pneumonia caused by Staphylococcus aureus in hospitalized patients on mechanical ventilation.

The FDA has given its approval for the structure of a single Phase 3 trial that is essential for backing the submission of a Biologics License Application (BLA). The trial will now encompass patients on ventilators who have contracted hospital-acquired pneumonia (HAP) and community-acquired pneumonia (CAP), as well as ventilator-associated pneumonia (VAP) caused by Staphylococcus aureus (S. aureus). The primary efficacy endpoint will focus on older adults (≥65 years) due to their higher response rate observed in a previous Phase 3 trial. The study will be powered to assess efficacy in both older adults and the overall study population. Aridis CEO Vu Truong expressed satisfaction with the FDA’s agreement on the study’s design, endpoints, and patient populations, stating that it provides a clear path for bringing AR-301 to patients in need and increasing potential partnerships with pharmaceutical companies.

AR-301-003 will serve as the second and final Phase 3 study to assess the effectiveness and safety of AR-301 as an additional treatment for pneumonia caused by Staphylococcus aureus in critically ill patients admitted to the hospital.

A randomized, double-blind trial will be carried out to assess superiority in this research. The main objective will be to evaluate the attainment of Clinical Cure for pneumonia on Day 21 after treatment in adults who are 65 years and older. Additional goals will include assessing Clinical Cure rates in participants aged ≥65 and <65 years, examining safety measures like healthcare utilization and all-cause mortality. The study is expected to involve around 200 clinical sites across more than 20 countries, including the United States, Latin and South America, Europe, and the Asia Pacific region.

AR-301 is a monoclonal antibody of human origin that specifically targets the alpha-toxin produced by S. aureus, safeguarding host cells from its harmful impact. Its effectiveness is not compromised by antibiotic resistance in S. aureus. In the Phase 3 trial, known as AR-301-002, patients who received treatment exhibited a noticeable trend towards an 11.3% enhancement in the rate of Clinical Cure at Day 21 compared to those who received a placebo. Notably, older adults (65+) experienced a 34% improvement on Day 21 and a 38% improvement on Day 28. AR-301 also demonstrated positive trends in secondary outcomes, such as reduced hospitalization duration, time in the ICU, and mechanical ventilation days. The safety profile of AR-301 was favorable. Hospital-acquired pneumonia caused by S. aureus poses significant challenges due to antibiotic resistance and high mortality rates.

The press release contained forward-looking statements reflecting Aridis’ expectations, but actual results may differ due to risks and uncertainties. Factors such as financing, regulatory approvals, clinical trial delays, competition, market acceptance, and reliance on third parties could impact outcomes. These factors are not exhaustive, and other undisclosed factors may also affect the realization of these statements. Market conditions and factors described in Aridis’ filings with the Securities and Exchange Commission can contribute to variations in actual results. Aridis has no obligation to update the forward-looking statements after the date of the press release.

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