CAMP4 Therapeutics Corporation announced on October 1, 2025, the initiation of toxicology studies conducted under Good Laboratory Practice (GLP) standards for its lead product candidate, CMP-SYNGAP-01. These studies are a crucial step in supporting the company’s planned submission of a clinical trial application.
The successful completion of these GLP toxicology studies could enable the initiation of a first-in-human Phase 1/2 clinical trial in SYNGAP1-related disorders as early as the second half of 2026. This marks significant progress for a program targeting a neurodevelopmental condition with no approved disease-modifying therapies.
CMP-SYNGAP-01 has previously demonstrated robust preclinical activity, including restoring SYNGAP1 protein levels to improve phenotypes in a mouse model and increasing SYNGAP1 protein in relevant brain regions of non-human primates. This preclinical validation provides confidence in the candidate's potential to translate into clinical benefit.
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