Vigil Neuroscience (VIGL) Issues 2023 Update, Highlights 2024 Milestones

Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today provided a 2023 year-in-review and outlined key milestones anticipated in 2024. The Company also today announced that it has extended its projected cash runway into the second half of 2025.

“2023 marked a year of persistent advancement and landmark achievements for the Company,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. “Most notably, we were the first company to demonstrate clinical data supporting TREM2 agonism as a potential therapeutic approach in neurodegenerative disease. We accomplished another first when we commenced dosing in our Phase 1 healthy volunteer clinical trial evaluating VG-3927, the only small molecule TREM2 agonist in the clinic for the potential treatment of Alzheimer’s disease.”

Key Clinical Program Highlights for 2023

Iluzanebart (VGL101): A fully human monoclonal antibody candidate targeting human triggering receptor expressed on myeloid cells 2 (TREM2)

• Completed Phase 1 clinical trial of iluzanebart and reported data from single and multiple ascending dose (SAD and MAD) cohorts in healthy volunteers, which demonstrated that iluzanebart continued to have a favorable safety and tolerability profile and showed proof-of-target engagement in SAD/MAD cohorts up to 60 mg/kg.
• Granted orphan drug designation for iluzanebart from the European Commission for the treatment of colony stimulating factor 1 receptor (CSF1R)-related leukoencephalopathy, which includes ALSP.
• Reported positive interim data from Phase 2 IGNITE proof-of-concept clinical trial of iluzanebart in ALSP. These data highlighted a favorable safety and tolerability profile and demonstrated clear CNS target engagement and downstream pharmacological activity and directionally supportive changes in individual patients at 6 months on magnetic resonance imaging (MRI) and neurofilament light chain (NfL) biomarkers.
• Reported findings from its ongoing natural history study, ILLUMINATE, which continued to provide critical insights on MRI and NfL biomarkers and support soluble CSF1R (sCSF1R) as a potential key biomarker of ALSP disease pathology.
• Based on the totality of the data reported in 2023 from the ILLUMINATE and IGNITE studies, the Company plans to engage with the U.S. Food and Drug Administration (FDA) in the first half of 2024 regarding a potential accelerated development pathway for iluzanebart in ALSP.

VG-3927: A highly active, selective, and brain-penetrant small molecule TREM2 agonist

• Received notification from the FDA that the Investigational New Drug (IND) application for VG-3927 was open and the Phase 1 clinical trial evaluating VG-3927 in healthy volunteers was allowed to proceed with a partial clinical hold related to maximum exposure limit. The Company is in the process of obtaining additional PK data and will work with the FDA to address the partial clinical hold. Based on preclinical studies, the Company believes that the maximum exposure limit exceeds the predicted efficacious dose of VG-3927.
• Dosed its first participant in the Phase 1 clinical trial of VG-3927 in healthy volunteers, making it the first and only small molecule TREM2 agonist in the clinic for the potential treatment of Alzheimer’s disease.

Key Corporate Highlights for 2023

• Launched ALSPAware, a new program providing no-cost genetic testing and counseling services for the diagnosis of ALSP.

Corporate Update & 2024 Anticipated Milestones

• The Company has extended its projected cash runway into the second half of 2025 by focusing its financial resources on current business priorities, including its iluzanebart and VG-3927 clinical development programs. The Company’s reallocation of capital is not expected to have any impact on employee headcount or anticipated development milestones.
• Vigil is on track to report interim data from the ongoing Phase 1 clinical trial of VG-3927 in healthy volunteers in mid-2024.
• The Company expects to report Phase 2 results from its IGNITE clinical trial evaluating iluzanebart in ALSP from all patients (n=15) at 6 months at both 20 mg/kg and 40 mg/kg doses in the third quarter of 2024.

“We enter 2024 well-positioned to achieve our planned value-driving milestones across our development pipeline,” concluded Dr. Magovčević-Liebisch. “We are confident in our ability to continue executing on our precision medicine strategy while thoughtfully allocating financial resources to best support our current development programs and our commitment to our patient communities.”

J.P. Morgan Healthcare Conference Details

The Company today announced that Dr. Magovčević-Liebisch will present at the 42^nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024, at 7:30 a.m. PT / 10:30 a.m. ET.

To register for the live event, please click here. The live webcast will also be available on the Company’s website on the “Events & Presentations” page in the “Investors” section. An archived webcast will be available for approximately 90 days following the presentation.

You May Also Be Interested In

• RenovoRx regains Nasdaq minimum bid price compliance
• reAlpha completes $8.5M InstaMortgage acquisition
• CoStar Group acquires Zonda for $800M, adding new home data