Vigil Neuroscience's Alzheimer's Candidate Shows Encouraging Safety Profile, Plans To Start Mid-Stage Study In Q3

On Thursday, Vigil Neuroscience Inc. VIGL released data from its completed Phase 1 trial evaluating VG-3927 as a potential treatment for Alzheimer’s disease.

Key takeaways from the Phase 1 clinical trial of VG-3927 include:

• Demonstrated a favorable safety and tolerability profile across all cohorts, including the elderly cohort.
• All related adverse events were mild or moderate in severity and self-resolving without drug discontinuations. No serious AEs were reported.
• Highly brain penetrant with a favorable and predictable PK profile that supports once-daily dosing.
• Achieved robust and dose-dependent reduction of sTREM2 of up to approximately 50% in the cerebral spinal fluid (CSF), demonstrating a strong PK/PD relationship, sustained target engagement, and TREM2 agonist activity.
• PK and sTREM2 reduction observed in the Alzheimer’s cohort was consistent with healthy volunteers and similar across evaluated TREM2 and ApoE genetic variants supporting development in Alzheimer’s disease across genotypes.
• PK and sTREM2 reduction observed in the elderly cohort was consistent with healthy volunteers.
• Combined clinical and in vivo preclinical data confirm that VG-3927 elicits neuroprotective activation of microglia downstream of TREM2 signaling. 

The company plans to advance a once-daily oral dose of 25mg and expects to initiate the Phase 2 trial in the third quarter of 2025.

William Blair writes that the 50% sTREM2 reduction improves on the interim Phase 1 data from healthy volunteers that showed significant reductions in sTREM2, with cohort means ranging from 20% to 25% decreases in the highest three dose levels.

Analyst Sarah Schram sees this as encouraging preliminary support of target engagement.

The analyst writes, “We are highly encouraged by today’s update, which comes after a robust Phase I study incorporating 14 cohorts and indicating consistent target engagement across participant groups.”

Vigil’s market cap is lower than the cash it reported at the end of last year’s third quarter, William Blair says, and the company is significantly undervalued compared to its potential and maintains an Outperform rating.

Price Action: VIGL stock is up 21.40% at $2.47 at the last check on Thursday.

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