Vigil Neuroscience announced interim data from its ongoing Phase 1 clinical trial of VG-3927 in healthy volunteers. Collectively, the interim safety, tolerability, pharmacokinetic and pharmacodynamic profile supports continued clinical development of VG-3927 as a potential once-daily oral therapy for AD. Additionally, these data showed that VG-3927 demonstrated functional and durable target engagement. Key takeaways from the interim data include the following: Safety and tolerability profile observed in individual doses in six SAD and two MAD cohorts in the ongoing Phase 1 clinical trial supports continued clinical development of VG-3927. All adverse events were mild or moderate in severity, and all AEs resolved without intervention. No serious adverse events have been reported to date. VG-3927 demonstrated a predictable PK profile that is supportive of once-daily dosing. In the SAD and MAD cohorts, VG-3927 achieved a robust and sustained decrease of sTREM2 in the CSF. VG-3927 also showed an increase in osteopontin/secreted phosphoprotein 1, a biomarker associated with neuroprotective microglia, after repeat dosing. An effect on soluble Colony Stimulating Factor 1 Receptor, a microglial trophic factor, has not been observed to date.
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