Success in drug development for treating viral hepatitis has major potential to launch a company on a global scale, says Dr. Lawrence Blatt, the CEO of the liver biotech Aligos Therapeutics.
“Gilead became a global pharmaceutical company because of its offerings in HIV and hepatitis C virus (HCV),” highlights Blatt, in an exclusive interview with Pharmaceutical Technology. This year marked a decade since the first US Food and Drug Administration (FDA) approval for Gilead Sciences’ disease-modifying HCV treatment, Sovaldi (sofosbuvir).
Blatt also calls attention to the journey of Vertex Pharmaceuticals, which started with the launch of an HCV treatment, before it became a global pharmaceutical company. Blatt adds that drug development in this space is essential due to the high unmet need.
In an April 2024 report, the World Health Organization (WHO) reported that viral hepatitis is the second leading infectious cause of death globally, causing 1.3 million deaths annually. WHO presented data from 187 countries, that showed the estimated number of deaths from viral hepatitis increased from 1.1 million in 2019 to 1.3 million in 2022 at the World Hepatitis Summit. Hepatitis B accounted for 83% of the deaths, while hepatitis C caused the remaining 17%.
Aligos is developing a capsid assembly modulator, ALG-000184, as a hepatitis B treatment. The South San Francisco, California-headquartered company presented data for the therapy at the June 2024 European Association of Liver Disease (EASL) Congress in Italy. In a Phase I study (NCT04536337), the company showed that 300mg ALG-000184 led to sustained hepatitis B virus (HBV) DNA suppression in 90% of the enrolled patients with high levels of virus in the blood (HBeAg-positive). In another cohort, patients with very low to no virus in their blood (HBeAg-negative) achieved nearly negative antibody levels upon taking the treatment.
In a 6 August company update, Aligos Therapeutics announced that it is currently preparing for a Phase II study, and working on its drug supply manufacturing plans, following positive US Food and Drug Administration feedback.
Hepatitis treatments continue to be a global issue, with Dr. Tedros Adhanom Ghebreyesus, the WHO director-general stating, “Despite progress globally in preventing hepatitis infections, deaths are rising because far too few people with hepatitis are being diagnosed and treated.”
“In HBV, [demonstrating] to investors and potential pharma partners that we have superiority and a clear path to registration, gives us a clear path for either partnership or financing,” says Blatt.
The global reach and burden of hepatitis opens up opportunities for collaboration globally, says Blatt. “Because HBV is such an important problem in China, this opens up an opportunity, for example, for a China-only partnership in HBV where we'll partner for that market, but maintain ownership for the rest of the world markets,” he says.
