Aligos Therapeutics Announces Clinical Collaboration with Xiamen Amoytop Biotech Co., Ltd.
Aligos Therapeutics (Nasdaq: ALGS) has announced a clinical trial collaboration with Xiamen Amoytop Biotech to evaluate the combination of ALG-000184 and PEGBING® (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. Amoytop will sponsor a Phase 1b exploratory study to assess the efficacy and safety of this combination.
ALG-000184 is a potent oral capsid assembly modulator (CAM-E) designed to disrupt hepatitis B cccDNA levels and reduce viral markers. It has shown promising results in Phase 1a and 1b studies. PEGBING®, developed by Amoytop, is a 40kD pegylated interferon α-2b injection used in viral hepatitis treatment.
The 48-week Phase 1b study will compare ALG-000184 + PEGBING® + entecavir (ETV) with ALG-000184 + ETV or PEGBING® + ETV in HBeAg-positive and HBeAg-negative CHB subjects.
Aligos Therapeutics (Nasdaq: ALGS) ha annunciato una collaborazione per uno studio clinico con Xiamen Amoytop Biotech per valutare la combinazione di ALG-000184 e PEGBING® (Mipeginterferon alfa-2b) in pazienti con epatite B cronica (CHB) in Cina. Amoytop sponsorizzerà uno studio esplorativo di Fase 1b per valutare l'efficacia e la sicurezza di questa combinazione.
ALG-000184 è un potente modulatore dell'assemblaggio della capsula (CAM-E) progettato per interrompere i livelli di cccDNA del virus dell'epatite B e ridurre i marker virali. Ha mostrato risultati promettenti negli studi di Fase 1a e 1b. PEGBING®, sviluppato da Amoytop, è un'iniezione di interferone α-2b pegilato da 40kD utilizzato nel trattamento dell'epatite virale.
Lo studio di Fase 1b della durata di 48 settimane confronterà ALG-000184 + PEGBING® + entecavir (ETV) con ALG-000184 + ETV o PEGBING® + ETV in soggetti con CHB positivi e negativi per HBeAg.
Aligos Therapeutics (Nasdaq: ALGS) ha anunciado una colaboración para un ensayo clínico con Xiamen Amoytop Biotech para evaluar la combinación de ALG-000184 y PEGBING® (Mipeginterferón alfa-2b) en pacientes con hepatitis B crónica (CHB) en China. Amoytop patrocinará un estudio exploratorio de Fase 1b para evaluar la eficacia y seguridad de esta combinación.
ALG-000184 es un potente modulador de ensamblaje de cápsides (CAM-E) diseñado para interrumpir los niveles de cccDNA del virus de la hepatitis B y reducir los marcadores virales. Ha mostrado resultados prometedores en los estudios de Fase 1a y 1b. PEGBING®, desarrollado por Amoytop, es una inyección de interferón α-2b pegilado de 40kD utilizado en el tratamiento de la hepatitis viral.
El estudio de Fase 1b de 48 semanas comparará ALG-000184 + PEGBING® + entecavir (ETV) con ALG-000184 + ETV o PEGBING® + ETV en sujetos con CHB positivos y negativos para HBeAg.
Aligos Therapeutics (Nasdaq: ALGS)는 Xiamen Amoytop Biotech와 협력하여 중국의 만성 B형 간염(CHB) 환자에서 ALG-000184와 PEGBING® (Mipeginterferon alfa-2b)의 조합을 평가하는 임상 시험 협력을 발표했습니다. Amoytop은 이 조합의 효능과 안전성을 평가하기 위한 1b 단계 탐색 연구를 후원할 예정입니다.
ALG-000184는 B형 간염 cccDNA 수준을 방해하고 바이러스 마커를 줄이도록 설계된 강력한 캡시드 조립 조절제(CAM-E)입니다. 1a 및 1b 단계 연구에서 유망한 결과를 보여주었습니다. Amoytop이 개발한 PEGBING®은 바이러스 간염 치료에 사용되는 40kD의 pegylated 인터페론 α-2b 주사입니다.
48주간의 1b 단계 연구는 ALG-000184 + PEGBING® + 엔테카비르(ETV)와 ALG-000184 + ETV 또는 PEGBING® + ETV를 HBeAg 양성 및 음성 CHB 대상자 간에 비교합니다.
Aligos Therapeutics (Nasdaq: ALGS) a annoncé une collaboration pour un essai clinique avec Xiamen Amoytop Biotech afin d'évaluer la combinaison de ALG-000184 et PEGBING® (Mipeginterferon alfa-2b) chez des patients atteints de hépatite B chronique (CHB) en Chine. Amoytop financera une étude exploratoire de Phase 1b pour évaluer l'efficacité et la sécurité de cette combinaison.
ALG-000184 est un puissant modulateur d'assemblage de capsides (CAM-E) conçu pour perturber les niveaux de cccDNA du virus de l'hépatite B et réduire les marqueurs viraux. Il a montré des résultats prometteurs lors des études de Phase 1a et 1b. PEGBING®, développé par Amoytop, est une injection d'interféron α-2b pegylé de 40kD utilisée dans le traitement de l'hépatite virale.
L'étude de Phase 1b de 48 semaines comparera ALG-000184 + PEGBING® + entecavir (ETV) avec ALG-000184 + ETV ou PEGBING® + ETV chez des sujets CHB positifs et négatifs pour HBeAg.
Aligos Therapeutics (Nasdaq: ALGS) hat eine klinische Studienkooperation mit Xiamen Amoytop Biotech angekündigt, um die Kombination von ALG-000184 und PEGBING® (Mipeginterferon alfa-2b) bei chronischen Hepatitis B (CHB) Patienten in China zu bewerten. Amoytop wird eine Phase 1b explorative Studie sponsern, um die Wirksamkeit und Sicherheit dieser Kombination zu bewerten.
ALG-000184 ist ein potenter oraler Capsid Assembly Modulator (CAM-E), der darauf abzielt, die cccDNA-Spiegel des Hepatitis-B-Virus zu stören und virale Marker zu reduzieren. In den Studien der Phase 1a und 1b wurden vielversprechende Ergebnisse erzielt. PEGBING®, entwickelt von Amoytop, ist eine 40kD-pegylierte Interferon α-2b-Injektion, die zur Behandlung von Virushepatitis eingesetzt wird.
Die 48-wöchige Phase 1b-Studie wird ALG-000184 + PEGBING® + Entecavir (ETV) mit ALG-000184 + ETV oder PEGBING® + ETV bei HBeAg-positiven und HBeAg-negativen CHB-Patienten vergleichen.
- Clinical collaboration with Amoytop to evaluate ALG-000184 in combination with PEGBING® for CHB treatment
- ALG-000184 demonstrated best-in-class reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg in Phase 1b studies
- ALG-000184 showed linear pharmacokinetics and excellent antiviral activity in Phase 1a studies
- Potential for improved clinical outcomes in CHB treatment through combination therapy
- None.
Amoytop to sponsor a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in CHB patients
SOUTH SAN FRANCISCO, Calif., July 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced that it has entered into a clinical trial collaboration agreement with Xiamen Amoytop Biotech Co., Ltd. (“Amoytop”).
Under the terms of the agreement, Amoytop will sponsor and perform a Phase 1b exploratory clinical study evaluating the efficacy and safety of ALG-000184 in combination with PEGBING® (Mipeginterferon alfa-2b) in chronic hepatitis B (CHB) patients in China. The clinical study is expected to begin after approval by the National Medical Products Administration in China.
“We are pleased to build on our existing relationship with Amoytop, as they have proven to be a valuable partner,” stated Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer at Aligos Therapeutics. “We look forward to initiating this exploratory study to evaluate the combination of ALG-000184 with PEGBING®, one of the approved drugs for CHB patients in China, to assess the potential benefits of a combinatory approach.”
ALG-000184 is a potent best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for CHB. It is designed to exploit the dual role of CAMs by disrupting hepatitis B cccDNA levels and its derived transcripts by reducing expression of viral markers such as DNA, RNA, and the relevant antigens (HBsAg, HBeAg, HBcrAg). Phase 1a studies have demonstrated after single and multiple daily doses that ALG-000184 was well-tolerated, with no safety signals observed, and demonstrated linear pharmacokinetics (PK) and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg x ≤96 weeks ± entecavir (ETV), ALG-000184 monotherapy has demonstrated best-in-class reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg without viral breakthrough to date.
PEGBING®, independently developed by Amoytop, is the world's first 40kD pegylated interferon α-2b injection. With dual effects of inhibiting viral replication and enhancing immunity, PEGBING® is mainly used in the clinical treatment of viral hepatitis and is the first-line drug for the antiviral treatment of chronic hepatitis B, which plays an important role in improving the clinical cure rate of hepatitis B and reducing the risk of liver cancer.
“We are pleased to deepen our cooperation in the field of liver disease treatment and look forward to working together to provide a new treatment solution for patients in need,” said Sun Li, Chairman and Chief Executive Officer at Amoytop. “Amoytop is committed to further optimizing the chronic hepatitis B combination treatment pathway and hopes that the cooperation will lead to better clinical value drugs and drug combinations.”
The Phase 1b study will be a randomized, double blinded, active controlled study to evaluate the safety, pharmacokinetics, and antiviral activity of oral once daily doses of 300 mg ALG-000184 + PEGBING® + entecavir (ETV) compared with 300 mg ALG-000184 + ETV or PEGBING® + ETV in treatment naïve or currently-not-treated HBeAg-positive and nucleos(t)ide analog (NA) suppressed HBeAg-negative subjects with CHB for 48 weeks.
About Aligos
Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses.
For more information, please visit www.aligos.com or follow us on LinkedIn or X.
About Xiamen Amoytop Biotech Co., Ltd.
Xiamen Amoytop Biotech Co., Ltd. is an innovative biopharmaceutical company and a listed company on the Science and Technology Innovation Board (SSE STAR Market) in China, specializing in R&D, manufacturing and marketing of regular and long-acting recombinant protein drugs. Focusing on the R&D of immune-related cytokine medicines, Amoytop is committed to becoming a leader in solving cytokine medicine-based systemic immune problems, providing better solutions for major diseases (such as viral hepatitis, malignant tumors) and immunotherapy.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including, without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
Aligos Therapeutics
Investor Contact
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com
Media Contact
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
Xiamen Amoytop Biotech Co., Ltd.
Investor Contact
Liu Peiyu
联系电话:86592-6889118
邮箱:ir@amoytop.com
Media Contact
Wu Xueyan
联系电话:86592-6889127
邮箱:wxy@amoytop.com
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FAQ
What is the purpose of Aligos Therapeutics' clinical collaboration with Xiamen Amoytop Biotech?
What is ALG-000184 and how does it work in treating chronic hepatitis B?
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