Benzinga | Sep 8, 2020 05:32AM EDT

Aridis Reaches Agreement with the FDA on Simplified Phase 2 Clinical Trial Design for AR-501

Aridis Pharmaceuticals, Inc. (NASDAQ:ARDS), today announced it has reached an agreement with the US Food and Drug Administration (FDA) to simplify the Company's AR-501 Phase 2 trial design for the treatment of chronic lung infections associated with cystic fibrosis (CF).

After reporting (June 2020) positive Phase 1 safety data in healthy adults who were exposed to a single ascending dose (SAD) or a multiple ascending dose (MAD) regimen, Aridis proposed, and the FDA has now agreed to streamline AR-501's forthcoming Phase 2a clinical trial in CF patients, by removing the SAD and only conducting a MAD regimen. Furthermore, the FDA also concurred with the Company's proposal to expand the originally planned Phase 2a protocol design into a Phase 2a/2b study. This Phase 2a/2b design will enable seamless and efficient advancement of the study from Phase 2a into Phase 2b using the same clinical study protocol. The data from the Phase 2a will inform the dose selection and sample size expansion to achieve statistical significance in efficacy in Phase 2b.

"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," commented Vu Truong, PhD, Chief Executive Officer of Aridis Pharmaceuticals. "We look forward to initiating the Phase 2a trial in the coming months and anticipate completing the study towards the end of 2021."