Vigil Neuroscience Announces First Participant Dosed in Phase 1 Clinical Trial in Healthy Volunteers Evaluating VG-3927, a Small Molecule TREM2 Agonist, for Potential Treatment of Alzheimer’s Disease
WATERTOWN, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced that the Company has dosed its first participant in a Phase 1 clinical trial in healthy volunteers evaluating VG-3927, the first and only small molecule TREM2 agonist in the clinic for the potential treatment of Alzheimer’s disease (AD).
“Dosing the first participant in our Phase 1 trial of VG-3927, the first and only small molecule TREM2 agonist in clinical development for assessment in AD, is an important milestone in our multi-modality strategy to develop novel therapeutics for the treatment of rare and common neurodegenerative diseases,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. “With approximately 6.7 million Americans living with AD, there remains a significant need for new therapies with improved safety and efficacy and that can broadly address multiple aspects of AD disease pathophysiology. Our orally bioavailable and highly CNS penetrant TREM2 agonist VG-3927 has a differentiated mechanism of action with multiple potential therapeutic advantages in AD, and we are excited to advance VG-3927 to potentially bring a differentiated treatment option to AD patients.”
The double-blind, placebo-controlled Phase 1 clinical trial plans to evaluate VG-3927 in SAD (single) and MAD (multiple) ascending dose cohorts in healthy volunteers. The study is designed to evaluate VG-3927’s safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). The Company anticipates reporting interim Phase 1 topline data in mid-2024.
Vigil’s highly active, selective, and brain-penetrant small molecule TREM2 agonist, VG-3927, is designed to act as a molecular glue that potentiates the TREM2 signaling response to natural damage ligands. In preclinical studies, Vigil has established that VG-3927 demonstrated on-target TREM2 activation across both common and rare TREM2 variants. Additionally, VG-3927 demonstrated preclinically that it was able to deliver in vivo TREM2 responses within the central nervous system at a magnitude and specificity similar to VGL101.
About Vigil Neuroscience
Vigil Neuroscience is a clinical-stage biotechnology company focused on developing treatments for both rare and common neurodegenerative diseases by restoring the vigilance of microglia, the sentinel immune cells of the brain. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities in our efforts to develop precision-based therapies to improve the lives of patients and their families. VGL101, our lead clinical candidate, is a fully human monoclonal antibody agonist targeting human triggering receptor expressed on myeloid cells 2 (TREM2) in people with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), a rare and fatal neurodegenerative disease. We are also developing VG-3927, a novel small molecule TREM2 agonist, to treat common neurodegenerative diseases associated with microglial dysfunction, with an initial focus on Alzheimer’s disease (AD) in genetically defined subpopulations.
This press release includes certain disclosures that contain “forward-looking statements” of Vigil Neuroscience, Inc.’s (Vigil or the Company) that are made pursuant to the safe harbor provisions of the federal securities laws, including, without limitation, express or implied statements regarding: the potential therapeutic benefit of our product candidates and the timing and availability of interim data from VG-3927’s Phase I trial. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties inherent in the development of therapeutic product candidates, including risks and uncertainties related to conducting clinical trials; the Company’s ability to recruit study subjects for clinical trials; the availability and timing of results and data from clinical trials; and the Company’s ability to work with the FDA to successfully remove the partial clinical hold on VG-3927; as well as the risks and uncertainties identified in the Company’s filings with the Securities and Exchange Commission (SEC), including Vigil’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and in any subsequent filings it may make with the SEC. Forward-looking statements contained in this announcement are made as of this date, and Vigil undertakes no duty to update such information except as required under applicable law. Readers should not rely upon the information on this page as current or accurate after its publication date.
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Vice President, Investor Relations & Corporate Communications
Vigil Neuroscience, Inc.