by Simantini Singh Deo
4 minutes
Aligos Therapeutics Receives FDA Approval to Move Forward With ALG-000184
From From Startup World | Pg 21
Aligos Therapeutics, Inc. (Nasdaq: ALGS) is a clinical-stage biopharmaceutical company dedicated to enhancing patient outcomes with leading-edge treatments for liver and viral diseases. The company has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 1 study focused on drug-drug interactions (DDI) involving ALG-000184, a capsid assembly modulator (CAM-E) aimed at treating Chronic Hepatitis B (CHB).
Lawrence Blatt, Ph.D., MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics, said in a statement, “The acceptance of our third U.S. IND is an important milestone for Aligos. 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.”
He also said, “ALG-000184 is the first novel, oral drug candidate for the treatment of HBV infection that can inhibit multiple components of the viral life cycle, leading to more complete suppression of the virus compared to other therapeutic modalities.”
The DDI study will examine the effect of cytochrome P450 inhibitor and inducer and pharmacokinetics of ALG-000184. Meanwhile, Phase 2 preparations are ongoing, with plans to submit for a Phase 2 trial in Q1 2025. This upcoming study will be a randomized, double-masked, active-controlled trial of ALG-000184 compared to standard treatment in both HBeAg-positive and HBeAg-negative CHB patients.
“ALG-000184 has demonstrated impressive data to date with broad antiviral activity. ALG-000184 can potentially 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,” stated Hardean Achneck, MD, Chief Medical Officer at Aligos Therapeutics.
Data from up to 72 weeks of daily oral dosing with 300 mg ALG-000184 has shown promising results, disrupting the entire HBV lifecycle and significantly reducing key viral markers such as HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg. Dosing continues for 96 weeks, with interim data expected at upcoming scientific meetings. ALG-000184 has received regulatory approval from the FDA and CDE (China) for chronic suppressive therapy, with a potential for superior labels in comparison with standards.
