According to Aridis Pharmaceuticals, the FDA has agreed to allow a Phase 2a trial of the company’s AR-501 nebulized formulation of gallium citrate for the treatment of lung infections in cystic fibrosis patients to skip a SAD study and move directly into a multiple ascending dose study. Aridis said that it proposed the new design after successfully completing a Phase 1/2a study that included SAD and MAD dosing regimens. The agency also agreed to a Phase 2a/2b trial design that would utilize the same protocol for both portions of the study.
The Phase 1 trial enrolled 48 healthy subjects who got either a single ascending dose or weekly multiple ascending doses of 6.4 mg gallium, 20 mg gallium, 40 mg gallium, or placebo.
Aridis Pharmaceuticals CEO Vu Truong commented, “The change to an adaptive style clinical trial design is an important milestone for the AR-501 program as it streamlines the regulatory pathway, expedites program timeline, and maximizes overall resources. We look forward to initiating the Phase 2a trial in the coming months and anticipate completing the study towards the end of 2021.”
AR-501 has orphan, Fast Track, and Qualified Infectious Disease Product (QIDP) designations in the US as well as orphan drug designation from the EMA.
Read the Aridis Pharmaceuticals press release.
