The Phase I trial has now expanded to include Alzheimer’s disease patients. Credit: Art_Photo / Shutterstock.

The US Food and Drug Administration (FDA) has lifted the partial clinical hold on Vigil Neuroscience’s Phase I trial of VG-3927, a novel treatment under development for neurodegenerative diseases.

This decision follows a complete response submitted to the regulator by the company.

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In July this year, Vigil Neuroscience shared interim findings from the single- and multiple-ascending dose study of VG-3927 in healthy subjects.

The safety and tolerability data from six SAD and two MAD cohorts indicated that VG-3927 is suitable for further clinical exploration.

The pharmacokinetic (PK) profile also supported the potential of the asset for once-daily dosing.

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In addition, VG-3927 has shown promising signs of efficacy, including a sustained decline in soluble TREM2 levels in the cerebrospinal fluid (CSF), providing clinical evidence of target engagement.

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An increase in osteopontin/secreted phosphoprotein 1 (SPP1) was also observed after repeated doses of the treatment.

The ongoing Phase I trial has now expanded to include patients suffering from Alzheimer’s disease, some of whom have TREM2 or other disease-related genetic variations.

This cohort will help assess VG-3927’s biomarker response after a single dose.

Vigil Neuroscience aims to release the complete Phase I data, including results from the Alzheimer’s patient cohort, in the first quarter of next year.

VG-3927 is a small molecule TREM2 agonist and is being developed to address neurodegenerative diseases linked to microglial dysfunction, with an initial focus on treating Alzheimer’s.

Vigil Neuroscience chief medical officer Petra Kaufmann said: “We are pleased with the resolution of the partial clinical hold, a decision that was supported by non-clinical and clinical data from our ongoing Phase I trial.

“While the partial clinical hold did not delay the clinical development of VG-3927, the option to increase the exposure limit provides us the best opportunity to explore the full pharmacology of VG-3927 as a potentially novel, next-generation therapy for those living with Alzheimer’s disease.”