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Trial Begins Testing RNA Hepatitis-B Treatment

Hepatitis-B virus

Hepatitis-B virus (CDC.gov, Pixnio)

14 Oct. 2022. A clinical trial is underway testing the safety and chemical activity of a hepatitis-B therapy using engineered RNA to block production of a key protein linked to the disease. The study is conducted by Aligos Therapeutics Inc. in South San Francisco, a biotechnology company developing treatments for viral and liver diseases.

Hepatitis-B is a viral infection of the liver, which when chronic, can become life-threatening from cirrhosis, or scarring of liver tissue, and liver cancer. The virus responsible for hepatitis-B is often spread through contact with blood and other bodily fluids, including from mother to child in pregnancy. World Health Organization says in 2019 some 296 million people worldwide were infected with hepatitis-B, leading to 820,000 deaths, mainly from liver cancer and cirrhosis.

Aligos Therapeutics lists chronic hepatitis-B as a prime disease target. One its treatment candidates, code-named ALG-125755, uses RNA interference to block production of a protein called hepatitis-B surface antigen or HBsAg, a key indicator of infection that also contributes to spread of the disease. RNA interference is a natural process where ribonucleic acid or RNA is produced by the body to silence the expression of specific disease-causing genes. Some short RNA chains are effective in silencing gene expression, with their use in therapies called small interfering RNA or siRNA.

“Potential to be administered less frequently than other drugs in this class”

Aligos adapts siRNAs in ALG-125755 to block expression of hepatitis-B surface antigens, and thus stop the spread of infection in people with the disease. The company believes ALG-125755 can be an important tool in controlling hepatitis-B, because of its siRNA mechansim. “Drugs in this class have generally been well tolerated and have consistently lowered HBsAg levels with more convenient dosing frequencies compared to other injectable HBsAg lowering agents,” says Aligos CEO Lawrence Blatt in a company statement.

Blatt adds, “This, coupled with the longer duration of action observed in non-clinical studies for ALG-125755 compared to other siRNAs, suggests that ALG-125755 has the potential to be administered less frequently than other drugs in this class.”

The early stage clinical trial aims to enroll a total of 120 participants, starting with healthy volunteers and later people with hepatitis-B. In the first part of the trial, healthy volunteers will test safety and tolerability of ALG-125755 in single escalating doses, looking mainly for adverse effects for 32 and 52 days, and then for up to two years. The study team is also looking for signs of ALG-125755 in blood plasma. The second part of the trial will test ALG-125755 against a placebo in single and multiple doses with hepatitis-B patients, and will track these same indicators plus hepatitis-B surface antigens levels. The company says it administered the first ALG-125755 dose in the trial.

“We plan to evaluate single ascending doses across multiple cohorts of healthy volunteers in Q4 2022,” says Aligos Therapeutics’ chief medical officer Matthew McClure. “Following that, beginning in Q1 2023, we then plan to evaluate single ascending doses across multiple cohorts of subjects with chronic hepatitis B. If the safety, pharmacokinetics, and pharmacodynamics of ALG-125755 in phase 1 are favorable, we then plan to combine this drug with other mechanisms of action in phase 2, where we hope to achieve high rates of functional cure.”

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