Aridis Pharmaceuticals’ AR-301 is eligible for consideration under FDA’s LPAD

Aridis Pharmaceuticals 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. Vu Truong, PhD, Chief Executive Officer of Aridis Pharmaceuticals, stated “We are encouraged by the FDA’s recognition of AR-301’s potential to address the urgent unmet medical needs of limited populations such as older adults over 65 years old. The eligibility for LPAD may provide an alternative pathway for product approval based on the available clinical data set and enable us to bring this innovative therapy to patients in need much sooner.”