Benzinga | Dec 7, 2021 08:28AM EST

Aligos Presents Update Of Chronic Hepatitis B Pipeline Portfolio At HEP DART 2021 From Dec. 5-9

Aligos Therapeutics, Inc. (NASDAQ:ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that company management, will deliver an invited oral presentation at the 2021 HEP DART meeting, being held December 5 -- 9, 2021 in Cabo San Lucas, Mexico.

Titled "Combination Approaches Towards a Functional Cure for Chronic Hepatitis B", the presentation provides new clinical and preclinical data as well as details on Aligos' strategic approach in developing a combination portfolio of multiple therapeutics designed to provide a functional cure for chronic hepatitis B (CHB). Aligos' portfolio includes several oligonucleotide modalities (ALG-010133, a proprietary STOPSTM molecule, ALG-020572, an antisense oligonucleotide (ASO), and ALG-125755, a siRNA), a small molecule capsid assembly modulator (CAM) and a newly announced program to discover an orally available small molecule PD-1/PD-L1 antagonist.

"We're very proud of the progress Aligos has made since the last HEP DART meeting in 2019 toward building a portfolio of purpose-built therapeutic candidates that target clinically validated mechanisms of CHB infection and persistence," said Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos. "The current standard of care in CHB effectively blocks viral replication, but it falls short of providing a functional cure as it must be administered for life. We believe that by targeting HBV antigen reduction, inhibiting viral replication and boosting immune responses, we can find one or more combinations of in-house candidates that can produce high rates of functional cure in CHB patients."

New data were shown at HEP DART from Aligos' Phase 1b study (ALG-000184-201, NCT04536337) of the company's CAM candidate ALG-000184. Cohort 4 enrolled 10 hepatitis B E-antigen positive chronic hepatitis B patients (8 ALG-000184: 2 placebo). HBeAg-positive cases of CHB are typically marked by active hepatitis B virus replication with high viral loads at baseline. After once daily oral dosing for 28 days with 100 mg of ALG-000184, there was an average reduction of 4 log10 IU/mL of HBV DNA and >3 log10 copies/mL of HBV RNA. This is similar to the responses recently observed in two cohorts of HBeAg-negative patient who received 50 mg or 100 mg doses of ALG-000184. ALG-000184 was well tolerated in CHB subjects regardless of HBeAg status. Evaluation of a 10 mg dose in HBeAg-negative subjects is ongoing.

Additionally, the presentation highlighted initial preclinical data on an oral small molecule PD-1/PD-L1 antagonist derived from the company's internal discovery engine, for potential addition of this immune boosting mechanism to Aligos' CHB portfolio. Proof-of-concept in CHB patients with anti-PD1 or PD-1 antibodies has been previously established in multiple clinical studies in the published literature where they demonstrated reductions in HBsAg. In addition to the other portfolio candidates' effects on HBsAg reduction and viral replication inhibition, Aligos' newly announced program is designed to promote endogenous T-cell activity against HBV to enhance viral clearance. An early lead compound, ALG-093453, is a small molecule PD-1/PD-L1 antagonist with excellent in vitro biochemical and cell-based potency and has been selected for further preclinical profiling and optimization.