AFFiRiS AG, a clinical-stage biopharmaceutical company developing novel disease-modifying specific active immunotherapies (SAITs) for patients with neurodegenerative diseases, will proceed with the preparations for the planned phase 2 study and confirms its intended initiation in the US and Europe in the second half of 2020.
The FDA has reviewed the pre-clinical data, the CMC-package, the clinical phase 1 study results and the phase 2 study plan of AFFITOPE® PD01. In its written response, the FDA addressed AFFiRiS’ questions and provided guidance on the design of the planned phase 2 trial.
“We are pleased to have completed the pre-IND process, with the FDA providing helpful guidance for the continued advancement of AFFITOPE PD01 for the treatment of Parkinson’s disease, an indication with an urgent and significant unmet medical need,” said Noel Barrett, Ph.D., AFFiRiS’ Chief Executive Officer. “We appreciate the FDA’s feedback as we endeavour to provide patients with a potentially disease-modifying immunotherapy utilizing our proprietary patented AFFITOME technology.”