Aridis Pharmaceuticals, Inc. announced that its AR-301 clinical program has been deemed eligible for consideration under the U.S. Food and Drug Administration's (FDA) Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD). The FDA's agreement signifies that the AR-301 clinical program meets the requirements for a well-defined limited population with unmet medical need as designated in the LPAD guidance. The official determination regarding the use of the LPAD pathway will be made after the Company's request following the filing of the biologics license application (BLA).

Eligible for LPAD can provide more streamlined approaches, such as smaller, shorter, or fewer clinical trials, as described in the FDA's 'Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases' guidance. Furthermore, it allows a drug approved under LPAD for certain indications to be approved under a non-LPAD pathway for other indications.