Vigil Neuroscience Announces FDA Has Removed Partial Clinical Hold on VG-3927
Vigil Neuroscience (Nasdaq: VIGL) announced that the FDA has removed the partial clinical hold on its Phase 1 trial of VG-3927, a potential treatment for Alzheimer's disease. The decision was based on non-clinical and clinical data from the ongoing trial. Interim data from July 2024 showed a favorable safety and tolerability profile, predictable pharmacokinetics supporting once-daily dosing, and proof of target engagement. The company has initiated dosing in Alzheimer's patients, including those with TREM2 variants. Vigil plans to report complete Phase 1 data, including results from the AD patient cohort, in Q1 2025.
Vigil Neuroscience (Nasdaq: VIGL) ha annunciato che la FDA ha rimosso il blocco clinico parziale sul suo studio di fase 1 per VG-3927, un potenziale trattamento per la malattia di Alzheimer. La decisione si basa su dati non clinici e clinici provenienti dallo studio in corso. I dati intermedi di luglio 2024 hanno mostrato un profilo di sicurezza e tollerabilità favorevole, una farmacocinetica prevedibile che supporta una somministrazione una volta al giorno e una prova di coinvolgimento del bersaglio. L'azienda ha iniziato la somministrazione ai pazienti affetti da Alzheimer, compresi quelli con varianti TREM2. Vigil prevede di riportare dati completi della fase 1, inclusi i risultati del gruppo di pazienti AD, nel Q1 2025.
Vigil Neuroscience (Nasdaq: VIGL) anunció que la FDA ha levantado la suspensión clínica parcial en su ensayo de fase 1 para VG-3927, un posible tratamiento para la enfermedad de Alzheimer. La decisión se basó en datos no clínicos y clínicos del ensayo en curso. Los datos intermedios de julio de 2024 mostraron un perfil de seguridad y tolerancia favorable, farmacocinética predecible que apoya una dosificación diaria y evidencia de compromiso del objetivo. La empresa ha iniciado la dosificación en pacientes con Alzheimer, incluidos aquellos con variantes TREM2. Vigil planea reportar datos completos de fase 1, incluidos los resultados de la cohorte de pacientes AD, en Q1 2025.
Vigil Neuroscience (Nasdaq: VIGL)는 FDA가 VG-3927에 대한 1상 시험의 부분적인 임상 보류를 해제했다고 발표했습니다. 이는 알츠하이머 병의 잠재적인 치료제입니다. 이 결정은 진행 중인 시험의 비임상 및 임상 데이터를 바탕으로 했습니다. 2024년 7월의 중간 데이터는 우호적인 안전성 및 내약성 프로파일과 하루 한 번의 복용을 지원하는 예측 가능한 약리학적 특성, 목표 관여를 입증했습니다. 회사는 TREM2 변이를 가진 환자들을 포함하여 알츠하이머 환자에게 약물 투여를 시작했습니다. Vigil은 2025년 1분기에 AD 환자 집단의 결과를 포함한 완전한 1상 데이터를 보고할 계획입니다.
Vigil Neuroscience (Nasdaq: VIGL) a annoncé que la FDA a levé la suspension clinique partielle de son essai de phase 1 pour VG-3927, un traitement potentiel pour la maladie d'Alzheimer. Cette décision est basée sur des données non cliniques et cliniques provenant de l'essai en cours. Les données intermédiaires de juillet 2024 ont montré un profil de sécurité et de tolérance favorable, une pharmacocinétique prédictible soutenant une posologie une fois par jour, et la preuve de l'engagement cible. L'entreprise a initié la dosage chez des patients atteints de la maladie d'Alzheimer, y compris ceux ayant des variantes TREM2. Vigil prévoit de rapporter les données complètes de la phase 1, y compris les résultats de la cohorte de patients AD, au Q1 2025.
Vigil Neuroscience (Nasdaq: VIGL) hat angekündigt, dass die FDA die partielle klinische Aussetzung seiner Phase-1-Studie für VG-3927, eine potenzielle Behandlung für Alzheimer, aufgehoben hat. Diese Entscheidung basierte auf nicht-klinischen und klinischen Daten aus der laufenden Studie. Interimsdaten vom Juli 2024 zeigten ein günstiges Sicherheits- und Verträglichkeitsprofil, vorhersehbare Pharmakokinetik, die eine einmal tägliche Dosierung unterstützt, und einen Nachweis des Zielengagements. Das Unternehmen hat mit der Dosierung bei Alzheimer-Patienten begonnen, einschließlich derjenigen mit TREM2-Varianten. Vigil plant, vollständige Phase-1-Daten, einschließlich der Ergebnisse der AD-Patientengruppe, im Q1 2025 zu berichten.
- FDA removed partial clinical hold on VG-3927 Phase 1 trial
- Interim data showed favorable safety and tolerability profile
- VG-3927 demonstrated proof of target engagement
- Pharmacokinetic profile supports once-daily dosing
- Initiated dosing in Alzheimer's disease patients
- None.
The FDA's removal of the partial clinical hold on VG-3927's Phase 1 trial is a significant positive development for Vigil Neuroscience. This decision allows the company to explore higher exposure limits, potentially enhancing the drug's efficacy profile. The FDA's action, based on non-clinical and clinical data, suggests increased confidence in the drug's safety.
The interim data showing a favorable safety profile, predictable pharmacokinetics and proof of target engagement are encouraging. The robust decrease in soluble TREM2 in the CSF is particularly noteworthy, as it indicates the drug is effectively reaching its intended target. The initiation of dosing in Alzheimer's patients, including those with genetic variants, could provide important insights into the drug's potential efficacy in the target population.
Vigil's approach targeting microglia through TREM2 modulation is at the forefront of Alzheimer's research. The increase in osteopontin/SPP1 after repeat dosing is intriguing, as SPP1 has been linked to neuroprotective effects and microglial activation. This could potentially indicate a dual mechanism of action for VG-3927.
The inclusion of AD patients with TREM2 or other disease-related variants in the study is a smart strategy. It may help identify specific genetic subgroups that could benefit most from the treatment, paving the way for a more personalized approach to Alzheimer's therapy. The anticipated complete Phase 1 data in Q1 2025 will be important for assessing VG-3927's potential as a novel AD treatment and informing the design of larger, more definitive trials.
For Vigil Neuroscience (NASDAQ: VIGL), this regulatory milestone could serve as a catalyst for increased investor interest. The removal of the partial clinical hold reduces regulatory risk and potentially accelerates the development timeline for VG-3927. While the company hasn't disclosed specific financial implications, the ability to explore higher dosages could enhance the drug's commercial potential if successful.
Investors should note that Alzheimer's disease represents a vast market opportunity, with high unmet medical needs. However, it's important to remain cautious as many promising AD treatments have failed in later-stage trials. The company's cash runway and ability to fund larger, more expensive trials will be critical factors to monitor. The Q1 2025 data readout will likely be a significant inflection point for the stock, potentially driving volatility based on the results.
WATERTOWN, Mass., Sept. 17, 2024 (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 U.S. Food and Drug Administration (FDA) has removed the partial clinical hold on its ongoing Phase 1 clinical trial of VG-3927. The FDA’s decision was based on a complete response submitted by the Company.
“We are pleased with the resolution of the partial clinical hold – a decision that was supported by non-clinical and clinical data from our ongoing Phase 1 trial,” said Petra Kaufmann, M.D., F.A.A.N., Chief Medical Officer at Vigil. “While the partial clinical hold did not delay clinical development of VG-3927, the option to increase the exposure limit provides us the best opportunity to explore the full pharmacology of VG-3927 as a potentially novel, next generation therapy for those living with Alzheimer’s disease.”
In July 2024, the Company reported interim data from the ongoing Phase 1 single- and multiple-ascending dose clinical trial evaluating VG-3927 in healthy volunteers. These data showed that the safety and tolerability profile observed in individual doses in six SAD and two MAD cohorts supported continued clinical development of VG-3927. In addition, VG-3927 demonstrated a predictable PK profile supportive of once-daily dosing. Importantly, VG-3927 achieved a robust and sustained decrease of soluble TREM2 in the CSF demonstrating clinical proof-of-target engagement. VG-3927 also showed an increase in osteopontin/secreted phosphoprotein 1 (SPP1) after repeat dosing.
As part of the Phase 1 clinical trial, the Company has initiated dosing of a cohort of Alzheimer’s disease (AD) patients, including some participants who carry TREM2 or other disease-related variants to explore the biomarker response of VG-3927 after a single dose. Vigil expects to use these data to inform the development strategy for subsequent and larger trials evaluating VG-3927 in AD. The Company plans to report the complete Phase 1 clinical data, including data from the AD patient cohort, in the first quarter of 2025.
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: Vigil’s strategy, business plans and focus; the potential therapeutic benefit of our product candidates, including VG-3927, and the expected therapeutic benefits of such programs; the timing, availability and utility of the complete Phase 1 clinical data from VG-3927’s Phase 1 clinical trial, and Vigil’s plans for further evaluation of the pharmacology of VG-3927. 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 clinical trials; whether results from preclinical studies and clinical trials will be predictive of the results of later preclinical studies and clinical trials; whether interim data results and analysis will be predictive of complete data results and analysis; 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, 2024 and in 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.
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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
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FAQ
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