Anavex Life Sciences Announces Successful Development of Once-Daily Oral Tablet Formulation for the ANAVEX®3-71 Program
Anavex Life Sciences (NASDAQ:AVXL) has successfully developed a new once-daily oral tablet formulation for its ANAVEX®3-71 program. The Phase 1b clinical trial (ANAVEX3-71-002) demonstrated that the modified-release tablet shows superior pharmacokinetics compared to the current immediate-release capsule.
The study confirmed the safety and tolerability of the new formulation in both male and female adults aged 18 and older. ANAVEX®3-71, a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator, aims to treat schizophrenia and neurodegenerative disorders with potential benefits across all symptom domains without standard antipsychotic side effects.
Anavex Life Sciences (NASDAQ:AVXL) ha sviluppato con successo una nuova compressa orale da prendere una volta al giorno per il programma ANAVEX®3-71. Lo studio di fase 1b ANAVEX3-71-002 ha dimostrato che la compressa a rilascio modificato presenta una farmacocinetica superiore rispetto all’attuale capsule a rilascio immediato.
Lo studio ha confermato la sicurezza e la tollerabilità della nuova formulazione in adulti di entrambi i sessi, dai 18 anni in su. ANAVEX®3-71, agonista duale del recettore SIGMAR1 e modulatore allostero positivo del recettore M1, si propone di trattare la schizofrenia e disturbi neurodegenerativi con potenziali benefici in tutti i domini sintomatici, senza gli effetti collaterali tipici degli antipsicotici.
Anavex Life Sciences (NASDAQ:AVXL) ha desarrollado con éxito una nueva forma de tableta oral de dosis única diaria para su programa ANAVEX®3-71. El ensayo de fase 1b ANAVEX3-71-002 mostró que la tableta de liberación modificada presenta farmacocinéticas superiores en comparación con la cápsula de liberación inmediata actual.
El estudio confirmó la seguridad y tolerabilidad de la nueva formulación en adultos de ambos sexos, mayores de 18 años. ANAVEX®3-71, un agonista dual del receptor SIGMAR1 y modulador alostérico positivo de M1, tiene como objetivo tratar la esquizofrenia y trastornos neurodegenerativos con posibles beneficios en todos los dominios de síntomas, sin los efectos secundarios típicos de los antipsicóticos.
Anavex Life Sciences (NASDAQ:AVXL)는 ANAVEX®3-71 프로그램을 위한 새로운 하루 한 번 복용 경구 정제 형태를 성공적으로 개발했습니다. 1b상 임상시험 ANAVEX3-71-002는 개량형 방출 정제가 현재의 즉시 방출 캡슐에 비해 약동학적으로 우수하다는 것을 보여주었습니다.
연구는 18세 이상 남녀 성인에서 신형 제형의 안전성과 내약성을 확인했습니다. ANAVEX®3-71은 이중 SIGMAR1 수용체 작용제와 M1 양성 작용성 조절제의 특성을 가진 이중 작용제이며, 표준 항정신병 약물의 부작용 없이 모든 증상 영역에서 잠재적 이점을 가진 정신분열증과 신경퇴행성 질환의 치료를 목표로 합니다.
Anavex Life Sciences (NASDAQ:AVXL) a développé avec succès une nouvelle forme posologique orale à prise unique quotidienne pour son programme ANAVEX®3-71. L’essai de phase 1b ANAVEX3-71-002 a démontré que le comprimé à libération modifiée présente une pharmacocinétique supérieure à celle de la capsule à libération immédiate actuelle.
L’étude a confirmé la sécurité et la tolérance de la nouvelle formulation chez les adultes des deux sexes, âgés de 18 ans et plus. ANAVEX®3-71, agoniste double du récepteur SIGMAR1 et modulateur allostérique positif du M1, vise à traiter la schizophrénie et les troubles neurodégénératifs avec des bénéfices potentiels dans tous les domaines symptomatiques, sans les effets secondaires typiques des antipsychotiques.
Anavex Life Sciences (NASDAQ:AVXL) hat erfolgreich eine neue orale Tablettenformulierung für eine einmal tägliche Einnahme für das ANAVEX®3-71-Programm entwickelt. Die Phase-1b-Studie ANAVEX3-71-002 zeigte, dass die modifizierte Freisetzungs-Tablette eine vorteilhafte Pharmakokinetik im Vergleich zur derzeitigen sofort freisetzenden Kapsel aufweist.
Die Studie bestätigte die Sicherheit und Verträglichkeit der neuen Formulierung bei erwachsenen Teilnehmern beider Geschlechter ab 18 Jahren. ANAVEX®3-71, ein dualer SIGMAR1-Rezeptor-Agonist und positiver allosterischer Modulator des M1, zielt darauf ab, Schizophrenie und neurodegenerative Erkrankungen zu behandeln, mit potenziellen Vorteilen in allen Symptomen, ohne die typischen Nebenwirkungen von Antipsychotika.
أنافيكس ليف ساينسز (ناسداك:AVXL) طوّرت بنجاح شكلًا جديدًا من الأقراص الفموية ذات الجرعة اليومية الواحدة لبرنامج ANAVEX®3-71. أظهرت تجربة المرحلة 1b ANAVEX3-71-002 أن قرص الإطلاق المعدل يظهر حركية دوائية تفوق القرص ذات الإطلاق الفوري الحالي.
أكدت الدراسة سلامة وقابلية تحمل الصيغة الجديدة لدى البالغين من الذكور والإناث الذين تبلغ أعمارهم 18 عامًا فما فوق. يهدف ANAVEX®3-71، وهو مناظر ثنائي لمستقبل SIGMAR1 ومُعدِّل allosteric إيجابي لـ M1، إلى معالجة الفصام والاضطرابات العصبية التنكسية مع فوائد محتملة في جميع مجالات الأعراض دون آثار جانبية نموذجية لمضادات الذهان.
Anavex Life Sciences (纳斯达克股票代码：AVXL) 已成功开发出用于 ANAVEX®3-71 计划 的新型每日一次口服片剂。Phase 1b 试验 ANAVEX3-71-002 显示，经修饰释放的片剂在药代动力学方面优于当前的即时释放胶囊。
研究证实了新制剂在18岁及以上男女受试者中的安全性和耐受性。ANAVEX®3-71，作为 SIGMAR1 受体的双重激动剂与 M1 正向别构调节剂，旨在治疗精神分裂症及神经退行性疾病，在所有症状领域可能具备益处，且不带有传统抗精神病药物的副作用。
- Successful development of once-daily oral tablet formulation with superior pharmacokinetics
- Phase 1b trial met primary endpoint for safety and tolerability
- New formulation enables more convenient once-daily dosing compared to current capsule
- Potential to treat all symptom domains of schizophrenia without standard antipsychotic side effects
- None.
Insights
Anavex's new once-daily tablet formulation for ANAVEX®3-71 shows superior pharmacokinetics and safety, advancing their CNS disorder treatment pipeline.
The successful development of a once-daily modified-release oral tablet formulation for ANAVEX®3-71 represents a significant advancement in Anavex's clinical pipeline. The Phase 1b trial (ANAVEX3-71-002) achieved its primary endpoint for safety and tolerability while demonstrating superior pharmacokinetics compared to the current immediate-release capsule.
This formulation improvement offers substantial practical benefits for potential patients. Once-daily dosing typically leads to better medication adherence compared to multiple daily doses, which is particularly important for conditions affecting cognition where compliance can be challenging. For neurodegenerative and psychiatric disorders like schizophrenia, simplified dosing regimens can significantly impact real-world treatment effectiveness.
The pharmacokinetic advantages likely include more consistent blood levels throughout the day, potentially reducing side effects associated with concentration spikes while maintaining therapeutic efficacy. ANAVEX®3-71's dual mechanism as both a SIGMAR1 receptor agonist and M1 positive allosteric modulator positions it uniquely among CNS therapeutics.
Most current schizophrenia medications primarily address positive symptoms (hallucinations, delusions) while struggling with negative symptoms (social withdrawal, anhedonia) and cognitive deficits. The company's claim that ANAVEX®3-71 could potentially treat all symptom domains without standard antipsychotic side effects would represent a substantial therapeutic advance if proven in later-stage trials.
This formulation optimization positions Anavex to move forward with a more commercially viable and patient-friendly product as they advance their clinical development program toward larger efficacy studies in schizophrenia and neurodegenerative conditions.
ANAVEX3-71-002 trial achieved its primary endpoint demonstrating safety and tolerability in both male and female adults
Oral ANAVEX®3-71 tablet exhibits superior pharmacokinetics compared to the current immediate-release oral capsule, enabling once-daily dosing
NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced successful development of a once-daily oral tablet formulation for the ANAVEX®3-71 program. The once-daily modified-release oral tablet exhibits superior pharmacokinetics compared to the current immediate-release oral capsule, enabling once-daily dosing. This achievement was confirmed in a Phase 1b clinical trial comparing the two dosage forms (ANAVEX3-71-002 trial).
The completed open-label, randomized study evaluated the pharmacokinetics and safety of immediate- and modified release formulations of ANAVEX®3-71 administered orally in healthy male and female adults 18 years or older. Study results demonstrated a pharmacokinetic profile supportive of once-daily dosing with a safety profile consistent with prior ANAVEX®3-71 studies.
“We are pleased to see that our latest ANAVEX®3-71 formulation study meets our expectations for safety and tolerability,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We believe that with the preferred modified release formulation, we can advance a competitive molecule into future studies, with the goal of addressing the present and persistent medical needs of people living with schizophrenia and neurodegenerative disorders.”
ANAVEX®3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects.1,2 ANAVEX®3-71 has previously been studied in healthy volunteers prior to study ANAVEX3-71-002 and the Phase 2 study ANAVEX3-71-SZ-001.3,4 This novel mechanism of action offers the potential to treat all symptom domains (positive, negative, and cognitive) of schizophrenia without the side effects of standard of care antipsychotics.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com
1 Fisher A, Bezprozvanny I, Wu L, et al. AF710B, a Novel M1/σ1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer’s Disease. Neurodegener Dis. 2016;16(1-2):95-110. doi:10.1159/000440864
2 Hall H, Iulita MF, Gubert P, et al. AF710B, an M1/sigma-1 receptor agonist with long-lasting disease-modifying properties in a transgenic rat model of Alzheimer's disease. Alzheimers Dement. 2018;14(6):811-823. doi:10.1016/j.jalz.2017.11.009
3 Fadiran EO, Hammond E, Tran J, et al. Concentration-QTc Relationship from a Single Ascending Dose Study of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease. Clin Pharmacol Drug Dev. 2023;12(9):888-901. doi:10.1002/cpdd.1303
4 Fadiran EO, Hammond E, Tran J, Missling CU, Ette E. Population-Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease. Clin Pharmacol Drug Dev. 2024;13(1):21-31. doi:10.1002/cpdd.1323
FAQ
What are the key findings of Anavex's ANAVEX3-71-002 clinical trial?
How does ANAVEX®3-71 work in treating schizophrenia?
What is the main advantage of Anavex's new tablet formulation?
What conditions does AVXL's ANAVEX®3-71 target?
Who was included in the ANAVEX3-71-002 clinical trial?
