FDA 483 - Lykos Therapeutics, Inc. - May 15, 2024

During an inspection conducted from April 29 to May 15, 2024, Lykos Therapeutics, Inc., a sponsor of clinical trials located in Santa Cruz, CA, received an FDA Form 483 citing two significant observations related to their conduct of clinical studies. The first observation highlighted inconsistencies between study protocols, safety manuals, and training materials concerning the definition of adverse events. Specifically, the MAPP2 safety manual and associated training materials presented a definition of adverse events that conflicted with the protocol, potentially excluding certain participant experiences considered positive from adverse event reporting, contrary to established study guidelines. The second observation noted a failure to adhere to protocol requirements for source documentation in both MAPP 1 and MAPP 2 studies. Investigators used scanned digital copies of CAPS-5 assessment data for electronic case report form (eCRF) entry, rather than the primary source documents as mandated by the protocol. This practice potentially compromised the integrity of data used in the primary endpoint analysis. These observations indicate issues in maintaining proper oversight and execution of clinical trials according to defined protocols and regulatory expectations for sponsors. Lykos Therapeutics, Inc. is expected to address these findings by submitting a response detailing corrective actions or objections to the FDA.