Aligos Therapeutics Announces U.S. FDA Clearance of IND Application for ALG-000184
Aligos Therapeutics (Nasdaq: ALGS) announced FDA clearance of its IND application for ALG-000184, a capsid assembly modulator for treating Chronic Hepatitis B (CHB). This allows the company to proceed with a Phase 1 Drug-Drug Interaction study and advance to Phase 2 clinical trials. The Phase 2 filing is expected in Q1 2025.
ALG-000184 is the first novel, oral drug candidate that can inhibit multiple components of the HBV lifecycle, potentially leading to more complete virus suppression. Data from ≤72 weeks of daily 300 mg doses showed best-in-class reductions in viral markers. The upcoming Phase 2 study will compare ALG-000184 to standard care in HBeAg-positive and negative CHB subjects.
The company anticipates enrolling patients next year and expects interim data readouts at upcoming scientific conferences. ALG-000184 has a clear regulatory path for chronic suppressive therapy with potential superiority over standard care.
Aligos Therapeutics (Nasdaq: ALGS) ha annunciato l'approvazione da parte della FDA della sua richiesta IND per ALG-000184, un modulatore dell'assemblaggio della capsula per il trattamento dell'Epatite B Cronica (CHB). Questo consente all'azienda di procedere con uno studio di interazione tra farmaci di Fase 1 e avanzare verso prove cliniche di Fase 2. Il deposito per la Fase 2 è previsto per il Q1 2025.
ALG-000184 è il primo candidato farmaco orale innovativo in grado di inibire più componenti del ciclo vitale dell'HBV, portando potenzialmente a una soppressione virale più completa. I dati di ≤72 settimane con dosi giornaliere di 300 mg hanno mostrato riduzioni di marker virali di classe superiore. Il prossimo studio di Fase 2 confronterà ALG-000184 con la cura standard in soggetti con CHB positivi e negativi per HBeAg.
L'azienda prevede di arruolare pazienti il prossimo anno e si aspetta letture intermedie dei dati in occasione delle prossime conferenze scientifiche. ALG-000184 ha un chiaro percorso regolatorio per la terapia suppessiva cronica con un potenziale di superiorità rispetto alla cura standard.
Aligos Therapeutics (Nasdaq: ALGS) anunció la aprobación de la FDA de su solicitud IND para ALG-000184, un modulador de ensamblaje de cápsida para el tratamiento de la Hepatitis B Crónica (CHB). Esto permite a la compañía proceder con un estudio de interacción entre medicamentos de Fase 1 y avanzar a ensayos clínicos de Fase 2. Se espera que la presentación para la Fase 2 ocurra en Q1 2025.
ALG-000184 es el primer candidato a fármaco oral novedoso que puede inhibir múltiples componentes del ciclo de vida del VHB, lo que podría llevar a una supresión viral más completa. Los datos de ≤72 semanas de dosis diarias de 300 mg mostraron reducciones de marcadores virales de clase superior. El próximo estudio de Fase 2 comparará ALG-000184 con el tratamiento estándar en sujetos con CHB positivos y negativos para HBeAg.
La empresa anticipa inscribir pacientes el próximo año y espera informes intermedios de datos en próximas conferencias científicas. ALG-000184 tiene un claro camino regulatorio para la terapia supresiva crónica con un potencial de superioridad sobre el tratamiento estándar.
Aligos Therapeutics (Nasdaq: ALGS)는 만성 B형 간염(CHB) 치료를 위한 캡시드 조립 조절제인 ALG-000184에 대한 IND 신청이 FDA 승인을 받았다고 발표했습니다. 이는 회사가 1상 약물 상호작용 연구를 진행하고 2상 임상 시험으로 나아갈 수 있는 길을 열어줍니다. 2상 신청은 2025년 1분기에 예상됩니다.
ALG-000184는 HBV 생애 주기의 여러 구성 요소를 억제할 수 있는 첫 번째 혁신적인 경구 약물 후보입니다. 이 약물은 더 완벽한 바이러스 억제를 가능하게 할 수 있습니다. ≤72주 동안 하루 300mg 용량에서 얻은 데이터는 최상의 바이러스 표지자 감소를 보여주었습니다. 다음 2상 연구에서는 HBeAg 양성 및 음성 CHB 환자를 대상으로 ALG-000184와 표준 치료를 비교할 것입니다.
회사는 내년에 환자를 모집할 예정이며, 다가오는 과학 회의에서 중간 데이터 보고가 있을 것으로 기대하고 있습니다. ALG-000184는 만성 억제 요법을 위한 명확한 규제 경로를 가지고 있으며, 표준 치료에 대한 우월성을 보여줄 가능성이 있습니다.
Aligos Therapeutics (Nasdaq: ALGS) a annoncé l'approbation par la FDA de sa demande IND pour ALG-000184, un modulateur d'assemblage de capsides pour le traitement de l'Hépatite B Chronique (CHB). Cela permet à l'entreprise de procéder à une étude d'interaction médicamenteuse de Phase 1 et de passer à des essais cliniques de Phase 2. La soumission pour la Phase 2 est prévue pour Q1 2025.
ALG-000184 est le premier candidat médicament oral novateur capable d'inhiber plusieurs composants du cycle de vie du VHB, ce qui pourrait conduire à une suppression virale plus complète. Les données d'une étude de ≤72 semaines avec des doses quotidiennes de 300 mg ont montré des réductions de marqueurs viraux de classe supérieure. La prochaine étude de Phase 2 comparera ALG-000184 aux soins standards chez les sujets atteints de CHB HBeAg-positifs et négatifs.
L'entreprise prévoit d'inclure des patients l'année prochaine et s'attend à des résultats intermédiaires lors des prochaines conférences scientifiques. ALG-000184 propose un chemin réglementaire clair pour un traitement suppressif chronique avec un potentiel de supériorité par rapport aux soins standards.
Aligos Therapeutics (Nasdaq: ALGS) gab die Genehmigung der FDA für seinen IND-Antrag für ALG-000184 bekannt, einen Kapsid-Assemblierungsmodulator zur Behandlung von chronischer Hepatitis B (CHB). Dies ermöglicht es dem Unternehmen, mit einer Studie zur Arzneimittelwechselwirkung der Phase 1 fortzufahren und in Phase 2 klinische Studien einzutreten. Der Antrag für Phase 2 wird für Q1 2025 erwartet.
ALG-000184 ist der erste neuartige, orale Wirkstoffkandidat, der mehrere Komponenten des HBV-Lebenszyklus hemmen kann und somit zu einer umfassenderen Virussuppression führen könnte. Daten aus ≤72-wöchigen täglichen 300 mg Dosen zeigten Best-in-Class-Reduktionen der viralen Marker. Die bevorstehende Phase-2-Studie wird ALG-000184 mit der Standardtherapie bei HBeAg-positiven und -negativen CHB-Patienten vergleichen.
Das Unternehmen rechnet damit, nächstes Jahr Patienten einzuschreiben und erwartet Zwischenberichte zu den Daten auf bevorstehenden wissenschaftlichen Konferenzen. ALG-000184 hat einen klaren regulatorischen Weg für eine chronische Suppressionstherapie mit potenzieller Überlegenheit gegenüber der Standardtherapie.
- FDA clearance of IND application for ALG-000184
- Advancement to Phase 2 clinical trials
- ALG-000184 shows potential for more complete HBV suppression
- Best-in-class reductions in viral markers observed in ≤72 weeks study
- Clear regulatory path with potential superiority label over standard care
- Phase 2 filing not expected until Q1 2025
- Ongoing dosing and data collection may delay final results
Insights
The FDA clearance of Aligos Therapeutics' IND for ALG-000184 is a significant milestone in the development of chronic hepatitis B (CHB) treatments. This novel capsid assembly modulator (CAM-E) shows promise in its ability to inhibit multiple components of the viral lifecycle, potentially offering more complete viral suppression than current therapies.
Key points to consider:
- The planned Phase 2 study in Q1 2025 will compare ALG-000184 to the standard of care, potentially demonstrating superiority.
- Data from up to 72 weeks of treatment has shown best-in-class reductions in viral markers, including HBV DNA, RNA, HBsAg, HBeAg and HBcrAg.
- The compound has a clear regulatory path endorsed by both the FDA and CDE (China), which could expedite its progress to market.
For investors, this development signals potential long-term value in Aligos' pipeline. However, it's important to note that the Phase 2 trial is still over a year away and success in early stages doesn't guarantee final approval or market success. The CHB market is competitive, but a superior treatment could capture significant market share if proven effective and safe in larger trials.
From a financial perspective, the FDA clearance for Aligos Therapeutics' IND is a positive development that could potentially increase the company's valuation in the long term. However, investors should consider several factors:
- With a market cap of only
$23.25 million , Aligos is a micro-cap biotech stock, which inherently carries high risk. - The company's cash runway and burn rate will be critical as it progresses towards the Phase 2 trial in Q1 2025.
- Potential partnerships or licensing deals could provide additional funding and validation of the technology.
While the news is promising, it's important to note that the time to market is still considerable. Investors should closely monitor upcoming data readouts and the company's financial health. The potential for a superior CHB treatment represents a significant market opportunity, but it's balanced against the long development timeline and inherent risks of drug development. This news may attract more institutional interest and could positively impact the stock in the near term, but substantial value creation is still dependent on future clinical success.
- Company to conduct a Phase 1 Drug-Drug Interaction Study
- Phase 2 filing on track for Q1 2025
SOUTH SAN FRANCISCO, Calif., Oct. 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) for a Phase 1 Drug-Drug Interaction (DDI) study of ALG-000184, a capsid assembly modulator (CAM-E) for the treatment of Chronic Hepatitis B (CHB).
“The acceptance of our third U.S. IND is an important milestone for Aligos,” said Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. “This IND clearance allows us to begin the next stages of our clinical development for ALG-000184, including the advancement of the compound into Phase 2 clinical trials. ALG-000184 is the first novel, oral drug candidate for the treatment of HBV infection that can inhibit multiple components of the viral lifecycle, leading to more complete suppression of the virus compared to other therapeutic modalities.”
The DDI study is designed to evaluate the effect of a cytochrome P450 inhibitor and inducer on ALG-000184 pharmacokinetics. In addition, Phase 2 enabling activities are ongoing, with a planned filing in Q1 2025 for the Phase 2 study. This clinical trial will be a randomized, double-blind, active controlled study of ALG-000184 vs. standard of care in HBeAg-positive and HBeAg-negative CHB subjects.
“ALG-000184 has demonstrated impressive data to date with broad antiviral activity,” stated Hardean Achneck, MD, Chief Medical Officer at Aligos Therapeutics. “ALG-000184 has the potential to improve outcomes compared to the current standard of care. We look forward to finalizing the Phase 2 study design in conjunction with KOLs and the FDA and anticipate enrolling patients next year.”
Data from ≤72 weeks following an oral daily dose of 300 mg ALG-000184 has demonstrated the ability to disrupt the entire HBV lifecycle through best-in-class reductions of the relevant viral markers: HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing through 96 weeks is ongoing, with interim data readouts expected at upcoming scientific conferences. ALG-000184 has a clear regulatory path endorsed by the FDA and CDE (China) for chronic suppressive therapy with a potential superiority label compared to standard of care.
About ALG-000184
ALG-000184 was derived from initial IP licensed from the laboratory of Dr. Raymond Schinazi at Emory University, which was further optimized by Aligos. ALG-000184 is a potent potential best/first-in-class oral small molecule capsid assembly modulator (CAM-E) being developed for chronic hepatitis B (CHB). 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 PK and excellent antiviral activity. In longer term Phase 1b studies of ALG-000184 300mg QD x ≤96 weeks ± Entecavir (ETV) and ALG-000184 monotherapy have demonstrated best-in-class sustained reductions in HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing is ongoing through 2025 with interim data readouts expected at upcoming scientific conferences. Phase 2 enabling activities are ongoing, with a planned Phase 2 IND filing in Q1 2025. ALG-000184 has a clear regulatory path endorsed by the FDA and CDE (China) for chronic suppressive therapy with a potential superiority label compared to standard of care.
About Chronic Hepatitis B
There were more than 290 million chronic carriers of Chronic Hepatitis B (CHB) worldwide as of July 2020 and approximately 30 million individuals become newly infected every year despite the availability of a prophylactic vaccine. In 2015, there were more than 90 million cases of CHB in China alone, while the European Union, United States and Japan accounted for nearly 8 million cases. Complications from CHB include cirrhosis, end-stage liver disease, and hepatocellular carcinoma, which collectively resulted in approximately 900,000 deaths in 2015, according to the World Health Organization. CHB is the primary cause of liver cancer worldwide, and the mortality associated with HBV-related liver cancer continues to increase.
About Aligos
Aligos Therapeutics, Inc. (NASDAQ: ALGS) is a clinical stage biopharmaceutical company founded with the mission to improve patient outcomes by developing best-in-class therapies for the treatment of liver and viral diseases. Aligos applies its science driven approach and deep R&D expertise to advance its purpose-built pipeline of 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.
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 August 6, 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.
Investor Contact
Aligos Therapeutics, Inc.
Jordyn Tarazi
Vice President, Investor Relations & Corporate Communications
+1 (650) 910-0427
jtarazi@aligos.com
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FAQ
What is the purpose of Aligos Therapeutics' Phase 1 Drug-Drug Interaction study for ALG-000184?
When is Aligos Therapeutics (ALGS) planning to file for the Phase 2 study of ALG-000184?
What are the key findings from the ALG-000184 study conducted by Aligos Therapeutics (ALGS)?
How does ALG-000184 differ from other Chronic Hepatitis B treatments according to Aligos Therapeutics?
