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Vigil Neuroscience, Inc. (VIGL) is a pioneering biopharmaceutical company dedicated to developing microglia-focused therapeutics. These specialized treatments aim to treat both rare and common neurodegenerative diseases by restoring the vigilance of microglia, the sentinel cells of the brain’s immune system. Vigil Neuroscience leverages modern neuroscience drug development tools to create precision-based therapies that significantly improve the quality of life for patients and their families.
One of the company's key initiatives is the clinical development of iluzanebart, which is currently in a Phase 2 Proof of Concept (PoC) trial named IGNITE. This is the first-ever interventional trial targeting Adult-onset Leukoencephalopathy with Axonal Spheroids and Pigmented Glia (ALSP) patients, marking a critical advancement in the treatment landscape for this rare disease. In addition, the company is working on VG-3927, an orally available small molecule TREM2 agonist designed to treat more common neurodegenerative diseases associated with microglial dysfunction.
Vigil Neuroscience has also made notable strides in community engagement and support. Their comprehensive patient support initiatives include the ALSPAware program, which offers no-cost genetic testing and counseling. This program aims to reduce the barriers to accurate diagnosis and enable better disease management for ALSP patients.
Recent research presented by the company has revealed significant findings on the diagnostic challenges faced by the ALSP community. For instance, a retrospective analysis disclosed that only 24.7 percent of ALSP patients received an accurate initial diagnosis, with many being misdiagnosed with multiple sclerosis (MS) due to similar early symptoms. Vigil Neuroscience's ongoing research aims to provide better diagnostic tools and treatment options, thereby improving the overall patient journey.
Additionally, Vigil Neuroscience has been actively presenting its latest findings and achievements at various conferences. Recent presentations have highlighted the potential of VG-3927 to treat neurodegenerative diseases like Alzheimer's Disease (AD), showcasing its neuroprotective profile and ability to favorably modulate microglia activation.
As Vigil Neuroscience continues to advance its clinical programs and expand its therapeutic pipeline, it remains committed to delivering innovative solutions that address the unmet needs of patients suffering from neurodegenerative diseases.
Vigil Neuroscience (NASDAQ: VIGL) presented data on its small molecule TREM2 agonist program at the 2024 Alzheimer's Association International Conference. The company shared clinical data from single ascending dose (SAD) cohorts in its ongoing Phase 1 trial of VG-3927, demonstrating proof-of-pharmacology with a robust decrease of sTREM2 in the CSF.
Key highlights include:
- In vivo data showing selective activation of downstream function leading to microglial amyloid-beta phagocytosis
- Acute modulation of AD pathophysiology comparable to an approved therapeutic
- In vitro data demonstrating preferential activity on cellular TREM2
- Phase 1 trial design details for VG-3927 in healthy volunteers
- Pharmacological and functional characterization of VG-3927 as a TREM2-specific, highly potent molecule
Vigil believes VG-3927 has the potential to offer a differentiated approach to treating Alzheimer's disease.
Vigil Neuroscience (Nasdaq: VIGL) has announced promising interim data from its ongoing Phase 1 clinical trial of VG-3927, a potential once-daily oral therapy for Alzheimer's disease (AD). The trial, which has enrolled 80 healthy volunteers, demonstrated a favorable safety and tolerability profile, with all adverse events being mild or moderate and resolving without intervention. Key findings include:
1. VG-3927 achieved a robust decrease in sTREM2 in cerebrospinal fluid, indicating clinical proof-of-target engagement.
2. The drug showed a predictable pharmacokinetic profile supporting once-daily dosing.
3. An increase in osteopontin/SPP1, a biomarker associated with neuroprotective microglia, was observed after repeat dosing.
Vigil plans to report complete Phase 1 data, including results from an AD patient cohort, in Q1 2025. The company will present new preclinical and clinical data at the upcoming 2024 Alzheimer's Association International Conference.
Vigil Neuroscience (Nasdaq: VIGL) announced three presentations on its small molecule TREM2 agonist VG-3927 at the 2024 Alzheimer's Association International Conference (AAIC) in Philadelphia. The presentations include:
1. An oral presentation on the characterization of VG-3927 for clinical development in Alzheimer's disease.
2. A poster on the design of a Phase 1, first-in-human study of VG-3927 in healthy volunteers.
3. A poster on the pharmacological and functional characterization of VG-3927 for Alzheimer's treatment.
These presentations highlight Vigil's progress in developing VG-3927 as a potential treatment for Alzheimer's disease, showcasing the company's focus on harnessing microglia for neurodegenerative diseases.
Vigil Neuroscience (Nasdaq: VIGL) has updated its clinical development strategy for iluzanebart in adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) following a Type C Meeting with the FDA. The company will preserve the IGNITE dataset for a final analysis at 12 months, foregoing an interim analysis. This approach aims to leverage their biomarker strategy and pursue a potential accelerated approval pathway.
The FDA has shown openness to considering accelerated approval, requesting additional data to support the proposed development plan. Vigil plans to report the final analysis from the IGNITE clinical trial in the first half of 2025, including all patients dosed with either 20 mg/kg or 40 mg/kg of iluzanebart over 12 months.
Vigil Neuroscience announced a $40 million strategic investment from Sanofi at an as-converted price of $7.44 per common share. Sanofi will acquire 537,634 Series A non-voting preferred shares, convertible into ten shares of common stock each. This investment provides Sanofi with an exclusive right of first negotiation for the license of Vigil's TREM2 agonist program, including VG-3927, currently in phase 1 trials for Alzheimer's treatment.
The funds from this investment will support Vigil's research and development, extending its cash runway into 2026. Vigil's CEO, Ivana Magovčević-Liebisch, emphasized the significance of Sanofi's investment as validation of their precision medicine approach. Sanofi's Global Head of Neurology Development, Erik Wallstroem, highlighted the importance of microglial signaling in neurodegenerative diseases and their commitment to immunoscience and neuroimmunology.
Augustine Therapeutics has secured EUR 17 million ($18.5 million) in the first closing of its Series A funding round. The financing was led by Asabys Partners, with participation from Eli Lilly and Company, and the Charcot-Marie-Tooth Research Foundation, among others.
The funds will advance AGT100216, a selective HDAC6 inhibitor, into a Phase 1/2 clinical trial in 2025, targeting neurological diseases like Charcot-Marie-Tooth and chemotherapy-induced peripheral neuropathies. Additional funds will support pipeline development and expand the executive and R&D team.
Gerhard Koenig has been appointed as Executive Chairman of the Board, while Clara Campàs from Asabys Partners has joined the Board of Directors.
Vigil Neuroscience, a clinical-stage biotech firm focused on neurodegenerative diseases, announced its participation in two upcoming investor conferences. The company's President and CEO, Ivana Magovčević-Liebisch, and Chief Science Officer, David Gray, will join a fireside chat at the Jefferies Global Healthcare Conference on June 6, 2024, at 9:30 a.m. ET. Additionally, Ivana Magovčević-Liebisch will present at the Goldman Sachs Global Healthcare Conference on June 11, 2024, at 10:40 a.m. ET. Live webcasts will be available on Vigil's website, with archived versions accessible for 90 days.
Vigil Neuroscience, Inc. (Nasdaq: VIGL) will present at the Citizens JMP Life Sciences Conference, showcasing their focus on harnessing microglia for treating neurodegenerative diseases. The management's participation in a fireside chat is scheduled for May 14th at 11:30 a.m. E.T. Interested individuals can register for the live event on the company's website. The webcast will also be accessible via the website for 90 days post-presentation.
Vigil Neuroscience, Inc. (Nasdaq: VIGL) reported its first-quarter financial results for 2024, noting progress in its clinical trials for iluzanebart and VG-3927. The company completed enrollment for Phase 2 trial of iluzanebart and is set for the next data readout in Q3 2024. VG-3927's Phase 1 trial for Alzheimer’s disease is ongoing, with interim data analysis expected in mid-2024. Vigil also appointed Petra Kaufmann, M.D., M.S., F.A.A.N, as Chief Medical Officer. Financially, the company's cash position stands at $101.6 million as of March 31, 2024.
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