Vigil Neuroscience Highlights 2024 Corporate Achievements and Upcoming 2025 Milestones
Vigil Neuroscience (NASDAQ: VIGL) highlighted its 2024 achievements and 2025 milestones. The company reported significant progress in its two TREM2 agonist programs and secured a $40 million strategic investment from Sanofi. Key developments include completing enrollment of 20 patients for the IGNITE Phase 2 trial of iluzanebart and surpassing 50 participants in the ILLUMINATE natural history study for ALSP.
The FDA indicated openness to considering accelerated approval for iluzanebart in ALSP. The company's VG-3927 program showed positive interim Phase 1 data in healthy volunteers and initiated dosing in Alzheimer's disease patients. The FDA removed a partial clinical hold on the VG-3927 trial.
Looking ahead to 2025, Vigil plans to report Phase 1 data for VG-3927 in Q1 and final analysis from the IGNITE Phase 2 trial for iluzanebart in Q2.
Vigil Neuroscience (NASDAQ: VIGL) ha messo in evidenza i suoi risultati del 2024 e i traguardi per il 2025. L'azienda ha riportato un progresso significativo nei suoi due programmi di agonisti TREM2 e ha assicurato un investimento strategico di $40 milioni da Sanofi. I principali sviluppi includono il completamento dell'arruolamento di 20 pazienti per lo studio clinico di Fase 2 IGNITE di iluzanebart e il superamento di 50 partecipanti nello studio sulla storia naturale ILLUMINATE per l'ALSP.
La FDA ha indicato apertura a considerare un'approvazione accelerata per iluzanebart nell'ALSP. Il programma VG-3927 dell'azienda ha mostrato dati positivi preliminari di Fase 1 in volontari sani ed ha iniziato la somministrazione a pazienti affetti da Alzheimer. La FDA ha rimosso una parziale sospensione clinica sul trial VG-3927.
Guardando al 2025, Vigil prevede di comunicare i dati di Fase 1 per VG-3927 nel primo trimestre e l'analisi finale del trial IGNITE di Fase 2 per iluzanebart nel secondo trimestre.
Vigil Neuroscience (NASDAQ: VIGL) destacó sus logros de 2024 y los hitos para 2025. La compañía reportó avances significativos en sus dos programas de agonistas TREM2 y aseguró una inversión estratégica de $40 millones de Sanofi. Los desarrollos clave incluyen la finalización de la inscripción de 20 pacientes para el ensayo de Fase 2 IGNITE de iluzanebart y superar los 50 participantes en el estudio de historia natural ILLUMINATE para ALSP.
La FDA indicó su disposición a considerar la aprobación acelerada para iluzanebart en ALSP. El programa VG-3927 de la compañía mostró datos preliminares positivos de Fase 1 en voluntarios sanos e inició la dosificación en pacientes con enfermedad de Alzheimer. La FDA levantó una suspensión clínica parcial en el ensayo VG-3927.
De cara a 2025, Vigil planea informar sobre los datos de Fase 1 para VG-3927 en el primer trimestre y el análisis final del ensayo IGNITE de Fase 2 para iluzanebart en el segundo trimestre.
Vigil Neuroscience (NASDAQ: VIGL)는 2024년 성과와 2025년 이정표를 강조했습니다. 이 회사는 두 개의 TREM2 작용제 프로그램에서 상당한 진전을 보고했으며 사노피로부터 4천만 달러의 전략적 투자를 확보했습니다. 주요 개발 사항으로는 iluzanebart의 IGNITE 2상 시험에 20명의 환자 등록을 완료하고 ALSP의 ILLUMINATE 자연 역사 연구에서 50명 이상의 참가자를 초과한 것이 포함됩니다.
FDA는 ALSP에서 iluzanebart에 대한 신속 승인 고려에 개방적임을 나타냈습니다. 회사의 VG-3927 프로그램은 건강한 자원자에서 긍정적인 1상 중간 데이터를 보여주었으며 알츠하이머병 환자에게 투여를 시작했습니다. FDA는 VG-3927 시험에 대한 부분적인 임상 보류를 해제했습니다.
2025년을 바라보며, Vigil은 1분기에 VG-3927의 1상 데이터를 보고하고 2분기에 iluzanebart의 IGNITE 2상 시험의 최종 분석을 보고할 계획입니다.
Vigil Neuroscience (NASDAQ: VIGL) a mis en avant ses réalisations de 2024 et ses objectifs pour 2025. L'entreprise a rapporté des progrès significatifs dans ses deux programmes d'agonistes TREM2 et a sécurisé un investissement stratégique de 40 millions de dollars de Sanofi. Les développements clés comprennent l'achèvement de l'inscription de 20 patients pour l'essai de phase 2 IGNITE d'iluzanebart et le dépassement de 50 participants dans l'étude sur l'histoire naturelle ILLUMINATE pour l'ALSP.
La FDA a indiqué une ouverture à envisager une approbation accélérée pour iluzanebart dans l'ALSP. Le programme VG-3927 de l'entreprise a montré des données intermédiaires positives de phase 1 chez des volontaires en bonne santé et a lancé l'administration chez des patients atteints de la maladie d'Alzheimer. La FDA a levé une suspension clinique partielle sur l'essai VG-3927.
En regardant vers 2025, Vigil prévoit de rapporter les données de phase 1 pour VG-3927 au premier trimestre et l'analyse finale de l'essai IGNITE de phase 2 pour iluzanebart au deuxième trimestre.
Vigil Neuroscience (NASDAQ: VIGL) hob seine Errungenschaften von 2024 und die Meilensteine für 2025 hervor. Das Unternehmen berichtete von bedeutenden Fortschritten in seinen zwei TREM2-Agonisten-Programmen und sicherte sich eine strategische Investition von 40 Millionen USD von Sanofi. Zu den wichtigen Entwicklungen zählt die vollständige Rekrutierung von 20 Patienten für die IGNITE Phase-2-Studie von iluzanebart sowie der Überschreiten von 50 Teilnehmern in der ILLUMINATE-Studie zur natürlichen Vorgeschichte von ALSP.
Die FDA zeigte sich offen für die Erwägung einer beschleunigten Zulassung für iluzanebart bei ALSP. Das VG-3927-Programm des Unternehmens zeigte positive vorläufige Phase-1-Daten bei gesunden Freiwilligen und begann die Behandlung bei Alzheimer-Patienten. Die FDA hob eine partielle klinische Sperre für die VG-3927-Studie auf.
Im Hinblick auf 2025 plant Vigil, im ersten Quartal Phase-1-Daten für VG-3927 zu berichten und die endgültige Analyse der IGNITE Phase-2-Studie für iluzanebart im zweiten Quartal vorzulegen.
- Secured $40 million strategic investment from Sanofi
- FDA open to considering accelerated approval pathway for iluzanebart in ALSP
- Exceeded enrollment targets with 20 patients in IGNITE Phase 2 trial
- Successful interim Phase 1 data for VG-3927
- FDA removed partial clinical hold on VG-3927 trial
- None.
Insights
The upcoming clinical trial data readouts for both VG-3927 and iluzanebart represent critical value-driving catalysts for Vigil Neuroscience. The Phase 1 VG-3927 data in Q1 2025 will be particularly scrutinized as it's backed by
The IGNITE Phase 2 trial for iluzanebart exceeded its enrollment target of 15 reaching 20 patients - this increased sample size strengthens statistical power. The FDA's openness to accelerated approval pathway significantly de-risks the regulatory strategy. The ILLUMINATE natural history study with over 50 participants provides robust control data for regulatory submissions.
For retail investors: Think of VG-3927 as a small "key" that fits perfectly into brain cells' "locks" (TREM2 receptors), while current antibody treatments are like bulky "master keys" that struggle to reach these locks. This could mean better treatment outcomes if the upcoming data is positive.
The Sanofi strategic investment and ROFN agreement is a major validation of Vigil's platform, particularly for VG-3927. With a
The dual-pronged approach targeting both rare disease (ALSP) and large market (Alzheimer's) provides compelling risk/reward. The accelerated approval pathway for iluzanebart in ALSP could enable faster commercialization in an orphan indication, while success in Alzheimer's represents substantial upside given the massive market opportunity.
Think of this strategy like having two lottery tickets - one for a smaller but more likely jackpot (ALSP) and another for a massive but more challenging prize (Alzheimer's). The Sanofi backing adds significant credibility to both programs.
– On track to report data from Phase 1 clinical trial evaluating VG-3927 for the treatment of Alzheimer’s disease in 1Q 2025 –
– Final analysis from IGNITE Phase 2 clinical trial evaluating iluzanebart in ALSP planned for 2Q 2025 –
– Company well-positioned for continued operational progress in 2025 –
WATERTOWN, Mass., Jan. 08, 2025 (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 highlighted 2024 corporate achievements and upcoming 2025 milestones.
“2024 was a year of strong operational execution, driven by the progress of our two TREM2 agonist programs, VG-3927 and iluzanebart, and a
2024 Key Achievements
Iluzanebart, Monoclonal Antibody TREM2 Agonist:
- Announced clinical development strategy update following Type C Meeting with U.S. Food and Drug Administration (FDA) where the Agency stated it was open to considering the accelerated approval pathway for iluzanebart in ALSP.
- Completed enrollment of 20 patients for IGNITE Phase 2 clinical trial, exceeding the initially planned 15 patients.
- Surpassed enrollment of 50 participants in ILLUMINATE natural history study of ALSP. Findings from ILLUMINATE have provided critical insights on MRI and NfL biomarkers and continue to improve the overall understanding of ALSP disease pathophysiology and progression.
VG-3927, Small Molecule TREM2 Agonist:
- Reported interim data from the ongoing Phase 1 clinical trial evaluating VG-3927 in healthy volunteers. These data demonstrated the safety, tolerability, pharmacokinetic, and pharmacodynamic profile supported continued clinical development. Initiated dosing of an Alzheimer’s disease (AD) cohort in the ongoing Phase 1 clinical trial, including some participants who carry TREM2 or other disease-related variants, to explore the biomarker response of VG-3927 after a single dose.
- FDA removed the partial clinical hold on the Phase 1 clinical trial of VG-3927 based on a complete response submitted by the Company.
- Presented new preclinical data on the small molecule TREM2 agonist program at the Alzheimer’s Association International Conference (AAIC) that highlighted its differentiated mechanism of action compared with antibody TREM2 agonists. These data demonstrated that Vigil’s small molecules, including VG-3927, are fully brain penetrant, do not bind to sTREM2 resulting in more drug reaching the target, and also act as a positive allosteric modulator (PAM) which amplifies the functional response within sites of pathology leading to greater horsepower for superior neuroprotection.
Corporate:
- Secured a
$40 million strategic investment from Sanofi to fund research and development activities. In connection with the equity investment, Vigil granted Sanofi the right of first negotiation (ROFN) for an exclusive license, grant or transfer of rights to research, develop, manufacture and commercialize the Company’s small molecule TREM2 agonist program, including its clinical candidate, VG-3927. - Appointed Petra Kaufmann, M.D., M.S., F.A.A.N, as Chief Medical Officer to lead the Company’s clinical, regulatory, and patient advocacy efforts.
2025 Milestones
- On track to report data in the first quarter of 2025 from the Phase 1 clinical trial of VG-3927, including single-ascending and multiple-ascending dose data from healthy volunteers, data from a single cohort of AD patients and data from an elderly patient cohort. Vigil expects to use these data to inform the development strategy for subsequent and larger trials evaluating VG-3927 in AD.
- Final analysis from the IGNITE Phase 2 clinical trial, including all patients at 12 months dosed with either 20 mg/kg or 40 mg/kg of iluzanebart, is planned for the second quarter of 2025. The Company will pursue an accelerated approval pathway for iluzanebart in ALSP and expects to share an update on its progress when the final analysis is reported.
“Building on the momentum from 2024, we plan to report key data for both VG-3927 and iluzanebart in the first half of 2025. We expect these development milestones will further support our efforts to bring potentially transformative therapies to patients with ALSP and AD,” concluded Dr. Magovčević-Liebisch. “Looking ahead, we aim to leverage our deep expertise in microglial biology to explore additional targets to treat other rare and common neurodegenerative diseases.”
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. Vigil is utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities in its efforts to develop precision-based therapies to improve the lives of patients and their families. Iluzanebart, Vigil’s 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. Vigil is 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) patients, including some who carry TREM2 and other disease-associated variants.
Forward-Looking Statements
This press release includes certain disclosures that contain “forward-looking statements” of Vigil Neuroscience (“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 Company’s strategy, business plans and focus; the potential therapeutic benefit of the Company’s product candidates, including iluzanebart and VG-3927, and the expected therapeutic benefits of such programs as well as the ability to improve the lives of patients and their families; the progress and timing of the clinical development of Vigil’s programs, including the availability of, and expected timing for reporting, data from both the IGNITE Phase 2 clinical trial and the VG-3927 Phase 1 clinical trial; beliefs about observations made analyzing preclinical study and clinical trial data to date; and the timing and outcomes of the Company’s interactions with regulatory authorities, including with the FDA regarding the accelerated approval pathway. Forward-looking statements are based on Vigil’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; and the timing and content of additional regulatory information from the FDA; 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 September 30, 2024 and any subsequent filings Vigil makes 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.
Internet Posting of Information
Vigil Neuroscience routinely posts information that may be important to investors in the 'Investors' section of its website at https://www.vigilneuro.com. The company encourages investors and potential investors to consult our website regularly for important information about Vigil Neuroscience.
Investor Contact:
Leah Gibson
Vice President, Investor Relations & Corporate Communications
Vigil Neuroscience, Inc.
lgibson@vigilneuro.com
Media Contact:
Megan McGrath
CTD Comms, LLC
megan@ctdcomms.com
FAQ
When will Vigil Neuroscience (VIGL) report Phase 1 data for VG-3927 in Alzheimer's disease?
What is the significance of Sanofi's $40 million investment in VIGL?
When will VIGL release final results from the IGNITE Phase 2 trial for iluzanebart?
How many patients are enrolled in VIGL's IGNITE Phase 2 trial for ALSP?
What is the FDA's stance on iluzanebart's approval pathway for ALSP treatment?
