Shares of Aridis Pharmaceuticals, Inc. (NASDAQ: ARDS) skyrocketed 97.30% on Wednesday to reach $0.37. This remarkable surge comes on the heels of the company’s recent agreement with the U.S. Food and Drug Administration (FDA) regarding a crucial Phase 3 study for their groundbreaking product, AR-301.
Aridis Pharmaceuticals, Inc. has been working tirelessly on the development of AR-301. AR-301 is a monoclonal antibody candidate designed to combat pneumonia caused by Gram-positive bacteria Staphylococcus aureus (S. aureus) in mechanically ventilated hospitalized patients.
The FDA has given its stamp of approval for a single confirmatory Phase 3 study of AR-301. The study will assess its effectiveness when used alongside standard-of-care (SOC) antibiotics.
Key agreements with FDA
Here are the key agreements reached between Aridis Pharmaceuticals and the FDA:
The FDA has given its approval for the design of a single confirmatory Phase 3 superiority study. This approval represents a crucial step toward submitting a Biologics License Application (BLA).
In addition, the FDA has given its approval for the expansion of the confirmatory Phase 3 study. Initially focused on S. aureus ventilator-associated pneumonia (VAP) patients, the study will now include ventilated hospital-acquired pneumonia (HAP) and ventilated community-acquired pneumonia (CAP) patients.
The clinical efficacy endpoint for this study will be the same as the one used in the previous Phase 3 trial (AR-301-002). It will focus on achieving a Clinical Cure for pneumonia on Day 21. However, the primary efficacy endpoint will be specifically evaluated in older adults aged 65 and above. This decision is based on the findings from the AR-301-002 study. The study demonstrated a higher efficacy rate (+34% improvement on Day 21 and +38% improvement on Day 28) in older adults compared to the overall population.
The confirmatory Phase 3 study, known as AR-301-003, will have two primary areas of focus. The first will be efficacy in adults aged 65 and above, which serves as the primary efficacy endpoint. The second key area of assessment will be the secondary efficacy endpoint in all study subjects. This includes both individuals aged 65 and above as well as those under 65 years of age.
This positive feedback and agreement from the FDA have generated significant optimism and investor enthusiasm, leading to a remarkable surge in Aridis Pharmaceuticals’ stock value. The company is now positioned to advance its research and potentially revolutionize the treatment of pneumonia caused by Gram-positive bacteria, providing hope for patients and investors alike.