Exhibit 99.1
Vigil Neuroscience Announces Interim Topline Results from its Ongoing Phase 1 Clinical Trial Evaluating VGL101 in Healthy Volunteers Supporting Phase 2 Initiation in ALSP
– VGL101 demonstrated favorable safety, tolerability and PK profiles in single ascending dose and multiple ascending dose cohorts -
– VGL101 achieved dose dependent, robust and durable decreases in CSF sTREM2 demonstrating proof of target engagement further validating its mechanism of action –
– On track to initiate Phase 2 trial with a 20 mg/kg dose of VGL101 in ALSP patients this quarter–
– Company to host conference call today at 8:00 a.m. ET–
CAMBRIDGE, Mass., November 2, 2022 (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 interim topline results from its ongoing Phase 1 clinical trial of VGL101, its lead product candidate, in healthy volunteers. These interim data support the initiation of a Phase 2 proof-of-concept trial in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) with a 20 mg/kg dose.
“We are very excited by the overall clinical profile of VGL101 seen to date and the progress our team has made in advancing this important program in less than one year’s time,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. “These interim data, alongside the anticipated initiation of the Phase 2 proof-of-concept trial in ALSP patients this quarter, are key milestones in the development of VGL101 for which we expect important data readouts in 2023.”
“Initiation of the Phase 2 trial will mark an important milestone for the ALSP community as it will be the first ever interventional trial in this underserved patient population. With this interim Phase 1 dataset, we demonstrated that VGL101 is safe, well tolerated, brain penetrant, and produces robust and durable reductions in sTREM2, validating its mechanism of action,” said Spyros Papapetropoulos, M.D., Ph.D., Chief Medical Officer of Vigil. “This interim Phase 1 dataset, combined with VGL101’s ability to rescue ALSP-like phenotypes in human microglia in our preclinical studies, gives us increased confidence in the therapeutic potential of VGL101 as we move toward Phase 2 clinical evaluation in patients.”
This ongoing trial is a Phase 1 single and multiple ascending dose trial to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VGL101. As of October 7, 2022, the trial had enrolled 82 healthy volunteers who received either VGL101 (n=68) at doses of 1, 3, 10, 20, 30 or 40 mg/kg or placebo (n=14). VGL101 was found to be safe and well-tolerated across both the SAD and MAD cohorts dosed.