Vigil Neuroscience Announces Interim Data from its Ongoing Phase 1 Clinical Trial Evaluating VG-3927 in Healthy Volunteers Supporting Continued Development in 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) ha annunciato dati provvisori promettenti dal suo studio clinico di Fase 1 in corso su VG-3927, una potenziale terapia orale da assumere una volta al giorno per l'Alzheimer (AD). Lo studio, che ha coinvolto 80 volontari sani, ha dimostrato un profilo di sicurezza e tollerabilità favorevoli, con tutti gli eventi avversi classificati come lievi o moderati e risolti senza intervento. I risultati chiave includono:
1. VG-3927 ha raggiunto una significativa riduzione di sTREM2 nel liquido cerebrospinale, indicando un'efficace prova di impegno terapeutico.
2. Il farmaco ha mostrato un profilo farmacocinetico prevedibile che supporta una somministrazione giornaliera.
3. È stata osservata un'aumento di osteopontina/SPP1, un biomarcatore associato a microglia neuroprotettive, dopo dosi ripetute.
Vigil prevede di riportare i dati completi della Fase 1, inclusi i risultati da un coorte di pazienti affetti da AD, nel primo trimestre del 2025. L'azienda presenterà nuovi dati preclinici e clinici alla prossima Conferenza Internazionale dell'Associazione Alzheimer 2024.
Vigil Neuroscience (Nasdaq: VIGL) ha anunciado datos interinos prometedores de su ensayo clínico de Fase 1 en curso sobre VG-3927, una posible terapia oral diaria para la enfermedad de Alzheimer (AD). El ensayo, que ha inscrito a 80 voluntarios sanos, demostró un perfil de seguridad y tolerabilidad favorable, con todos los eventos adversos siendo leves o moderados y resolviéndose sin intervención. Los principales hallazgos incluyen:
1. VG-3927 logró una disminución robusta de sTREM2 en el líquido cefalorraquídeo, indicando una prueba clínica de compromiso terapéutico.
2. El medicamento mostró un perfil farmacocinético predecible que apoya la dosificación diaria.
3. Se observó un aumento de osteopontina/SPP1, un biomarcador asociado con microglía neuroprotectora, después de dosis repetidas.
Vigil planea informar sobre los datos completos de la Fase 1, incluidos los resultados de una cohorte de pacientes con AD, en el primer trimestre de 2025. La empresa presentará nuevos datos preclínicos y clínicos en la próxima Conferencia Internacional de la Asociación de Alzheimer 2024.
Vigil Neuroscience (Nasdaq: VIGL)는 VG-3927, 하루에 한 번 복용 가능한 알츠하이머병 (AD) 치료제에 대한 진행중인 임상 1상 시험의 유망한 중간 결과를 발표했습니다. 80명의 건강한 자원봉사자를 모집한 이번 시험은 모든 부작용이 경미하거나 중간 정도로 나타나고 개입 없이 해결되는 등 안전성과 내약성에서 긍정적인 프로필을 보였습니다. 주요 발견 사항은 다음과 같습니다:
1. VG-3927은 신경척수액에서 sTREM2의 강력한 감소를 달성하여 임상적 타겟 참여 증거를 나타냈습니다.
2. 이 약물은 하루에 한 번 복용을 지원하는 예측 가능한 약리학적 프로필을 보였습니다.
3. 반복 복용 후 신경 보호 미세교류와 연결된 바이오마커인 오스테오폰틴/SPP1의 증가가 관찰되었습니다.
Vigil은 2025년 1분기 동안 AD 환자 집단의 결과를 포함한 1상 데이터 전체를 보고할 계획입니다. 회사는 다가오는 2024년 알츠하이머 협회 국제 회의에서 새로운 전임상 및 임상 데이터를 발표할 것입니다.
Vigil Neuroscience (Nasdaq: VIGL) a annoncé des données préliminaires prometteuses de son essai clinique de Phase 1 en cours sur VG-3927, une potentielle thérapie orale à prendre une fois par jour pour la maladie d'Alzheimer (AD). L'essai, qui a recruté 80 volontaires en bonne santé, a démontré un bon profil de sécurité et de tolérance, tous les événements indésirables étant de nature légère ou modérée et se résolvant sans intervention. Les résultats clés incluent :
1. VG-3927 a montré une réduction significative de sTREM2 dans le liquide céphalorachidien, indiquant une preuve clinique de l'engagement de la cible.
2. Le médicament a affiché un profil pharmacocinétique prévisible qui soutient une dose quotidienne.
3. Une augmentation de l'ostéopontine/SPP1, un biomarqueur associé aux microglies neuroprotectrices, a été observée après des doses répétées.
Vigil prévoit de rapporter les données complètes de la Phase 1, y compris les résultats d'une cohorte de patients atteints d'AD, au premier trimestre 2025. L'entreprise présentera de nouvelles données précliniques et cliniques lors de la prochaine Conférence Internationale de l'Association Alzheimer 2024.
Vigil Neuroscience (Nasdaq: VIGL) hat vielversprechende vorläufige Daten aus seiner laufenden Phase-1-Studie zu VG-3927, einer potenziellen einmal täglichen oralen Therapie für Alzheimer (AD), veröffentlicht. Die Studie, an der 80 gesunde Freiwillige teilnahmen, zeigte ein günstiges Sicherheits- und Verträglichkeitsprofil, da alle unerwünschten Ereignisse mild oder moderat und ohne Intervention wieder abklangen. Zu den wichtigsten Ergebnissen gehören:
1. VG-3927 erreichte einen signifikanten Rückgang von sTREM2 in der Gehirn-Rückenmarks-Flüssigkeit, was auf einen klinischen Nachweis des therapeutischen Ziels hindeutet.
2. Das Medikament zeigte ein vorhersehbares pharmakokinetisches Profil, das eine einmal tägliche Dosierung unterstützt.
3. Nach wiederholter Dosierung wurde ein Anstieg von Osteopontin/SPP1 festgestellt, ein Biomarker, der mit neuroprotektiven Mikroglia assoziiert ist.
Vigil plant, vollständige Phase-1-Daten, einschließlich Ergebnisse aus einer AD-Patienten-Kohorte, im ersten Quartal 2025 zu berichten. Das Unternehmen wird neue präklinische und klinische Daten auf der bevorstehenden Internationalen Alzheimer-Kongress 2024 präsentieren.
- VG-3927 demonstrated a favorable safety and tolerability profile in Phase 1 trial
- The drug achieved robust decrease of sTREM2 in CSF, indicating clinical proof-of-target engagement
- Pharmacokinetic profile supports once-daily dosing
- Increase in osteopontin/SPP1 observed, suggesting activation of neuroprotective microglia
- Company plans to present new preclinical and clinical data at 2024 AAIC
- Complete Phase 1 data, including AD patient cohort results, not available until Q1 2025
- No effect on soluble Colony Stimulating Factor 1 Receptor (sCSF1R) observed to date
Insights
The interim data from Vigil Neuroscience on VG-3927 is promising for the future of Alzheimer's disease (AD) treatment. The robust decrease of sTREM2 in cerebrospinal fluid (CSF) is significant because sTREM2 is a biomarker linked to AD; its reduction suggests effective target engagement. Achieving this with an oral therapy provides a potential competitive edge over intravenous alternatives.
Furthermore, the safety and tolerability profile, with all adverse events being mild or moderate, supports the drug's viability for long-term use. The next step of testing in AD patients will be critical to validate these findings in a real-world scenario. Investors should watch for this data in Q1 2025, as it could substantially impact the stock's valuation if positive results continue.
The announcement from Vigil Neuroscience is strategically timed and could impact investor sentiment positively. Alzheimer's disease affects millions globally and any advancement in treatment options is closely monitored by the market. The mention of presenting these findings at a prominent conference like the Alzheimer's Association International Conference (AAIC) could build momentum and visibility for the company.
From a market perspective, the data supports the continuation of VG-3927 development, which aligns with investors' expectations for innovation and progress in the biotech sector. Key milestones to watch include the conference presentation and the full Phase 1 data release in early 2025. The current interim data sets a strong foundation for potential future gains.
Financially, this interim data release is a positive indicator for Vigil Neuroscience. Successful Phase 1 trials often lead to increased investor confidence and potential funding opportunities. The robust decrease in sTREM2 and the manageable adverse events profile are both favorable outcomes that de-risk the pipeline asset VG-3927.
Given the ongoing trend of increased investment in neurodegenerative disease treatments, Vigil Neuroscience may find attracting additional capital for further trials easier. In the short term, the presentation at AAIC could act as a catalyst, potentially driving the stock price. Long-term, the full Phase 1 results will be crucial. Investors should monitor cash burn rates and funding needs as the company progresses through its clinical milestones.
- Safety, tolerability, pharmacokinetic and pharmacodynamic profile of VG-3927 supports continued development as potential once-daily oral therapy for Alzheimer’s disease (AD) -
- VG-3927 achieved robust decrease of sTREM2 in CSF demonstrating clinical proof-of-target engagement-
- New preclinical and clinical data from SAD cohorts to be presented at upcoming 2024 Alzheimer’s Association International Conference (AAIC) -
- Company plans to report complete Phase 1 data, including data from AD cohort, in Q1’2025 -
WATERTOWN, Mass., July 24, 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 interim data from its ongoing Phase 1 clinical trial of VG-3927 in healthy volunteers. Collectively, the interim safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profile supports continued clinical development of VG-3927 as a potential once-daily oral therapy for AD. Additionally, these data showed that VG-3927 demonstrated functional and durable target engagement.
“We are encouraged by these data which demonstrate that VG-3927 has the potential to become a differentiated approach to treating AD,” said Ivana Magovčević-Liebisch, Ph.D., J.D., President and Chief Executive Officer of Vigil. “With approximately 6.7 million Americans living with AD, there is a critical need for new therapies with improved safety and efficacy that can broadly address multiple aspects of AD disease pathophysiology.”
“These interim clinical findings showed that VG-3927 had a significant impact on sTREM2, a key biomarker in AD, and supports VG-3927 as a potent molecule that functionally engages TREM2 receptors in the brain. We achieved similar levels of sTREM2 target engagement with our monoclonal antibody iluzanebart in its Phase 1 clinical trial. These data further strengthen our belief that VG-3927 is acting as a TREM2 agonist and converting microglia into a neuroprotective state,” said Petra Kaufmann, M.D., F.A.A.N., Chief Medical Officer of Vigil. “Combined with the extensive preclinical data that we have collected, we believe VG-3927 is well-positioned for further development in AD. We look forward to advancing VG-3927 with the goal of ultimately providing a new therapy to those impacted by AD.”
The ongoing trial is a Phase 1 single and multiple ascending dose trial to assess the safety, tolerability, PK and PD of VG-3927. As of June 30, 2024, the trial had enrolled 80 healthy volunteers, of which 60 have received VG-3927 across multiple SAD and MAD cohorts.
Key takeaways from the interim data include the following:
- Safety and tolerability profile observed in individual doses in six SAD and two MAD cohorts in the ongoing Phase 1 clinical trial supports continued clinical development of VG-3927.
- All adverse events (AEs) were mild or moderate in severity, and all AEs resolved without intervention. No serious adverse events have been reported to date.
- VG-3927 demonstrated a predictable PK profile that is supportive of once-daily dosing.
- In the SAD and MAD cohorts, VG-3927 achieved a robust and sustained decrease of sTREM2 in the CSF.
- VG-3927 also showed an increase in osteopontin/secreted phosphoprotein 1 (SPP1), a biomarker associated with neuroprotective microglia, after repeat dosing.
- An effect on soluble Colony Stimulating Factor 1 Receptor (sCSF1R), a microglial trophic factor, has not been observed to date.
As part of the Phase 1 clinical trial, the Company has commenced screening for a cohort of 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. The Company plans to use these data to inform the development strategy for subsequent and larger trials evaluating VG-3927 in AD. Vigil plans to report the complete Phase 1 clinical data, including data from the AD patient cohort, in the first quarter of 2025.
The Company also announced today that it plans to present new preclinical data from its small molecule program, including in vivo AD-related functional data, and clinical data from the VG-3927 SAD cohorts in the Phase 1 clinical trial, in an oral presentation at the upcoming 2024 Alzheimer’s Association International Conference (AAIC) taking place on July 28 – August 1, 2024 in Philadelphia, Pennsylvania and virtually. Please click here for more information on Vigil’s presentations at AAIC.
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 as well as the potential market size and ability to address a major unmet medical need; the timing and availability of future interim data readouts as well as the complete Phase 1 clinical data from VG-3927’s Phase 1 clinical trial; VG-3927’s potential as a TREM2 agonist and its ability to convert microglia into a neuroprotective state. 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; whether results from preclinical studies and clinical trials will be predictive of the results of later preclinical studies and clinical trials; the timing and content of additional regulatory interactions with the FDA – including the Company’s discussions regarding the partial clinical hold on VG-3927; 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 March 31, 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.
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
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