Lykos Therapeutics, Inc. – FDA EIR, May 15, 2024

An FDA inspection of Lykos Therapeutics, Inc. was conducted from April 29 to May 15, 2024, focusing on their phase 3 studies (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for Posttraumatic Stress Disorder under NDA 215455. This high-priority surveillance inspection, performed under regulatory guidelines, aimed to assess the adequacy of safety evaluation and reporting processes, as well as various aspects of clinical trial conduct. Upon conclusion, a FORM FDA 483, Inspectional Observations, was issued. Key violations included the firm's failure to provide investigators with necessary study information and ensure adherence to protocols/investigational plans. Management was also formally addressed regarding several issues: missing senior independent rater approval for critical assessments, discrepancies between scanned and primary source assessment copies, inconsistent participant access to video session recordings, and protocol deviations in screening training and management. Additionally, the inspection identified concerns from a previous audit, including unresolved adverse event queries and insufficient review of experimental session videotapes. A significant issue raised was contradictory information in the MAPP2 safety manual regarding the definition and reporting of adverse events, specifically the 'Ineffable Side Effects' section. The firm was informed that these observations could lead to legal sanctions, including data rejection, civil penalties, or prosecution. Lykos Therapeutics verbally acknowledged understanding of the findings.