Phase 3 Trial of brelovitug for hepatitis D enrolls 1st patient
Investigational therapy being tested against bulevirtide in adults
The first participant has been enrolled in a Phase 3 clinical trial testing Bluejay Therapeutics’ investigational therapy brelovitug against bulevirtide in adults with chronic hepatitis D.
Bulevirtide is an antiviral therapy approved in some countries under the brand name Hepcludex for treating hepatitis D. It does not have regulatory approval in the U.S.
The trial, dubbed AZURE-2 (EUCT 2024-517167-23-00), is running at sites in Europe, with plans to enroll around 172 participants.
Meanwhile, the Phase 2b/3 AZURE-1 trial (NCT06907290), which is testing the safety and efficacy of brelovitug treatment compared with delayed treatment, is still recruiting around 150 adults with chronic hepatitis D in the U.S., European Union, and Israel. It started dosing earlier this year.
“Bluejay continues to swiftly advance our registrational program for brelovitug in [chronic hepatitis D],” Keting Chu, MD, PhD, founder, CEO, and chairman of Bluejay, said in a company press release. “We are proud to support the patients and providers in need of new hope.”
Registrational programs comprise later-stage clinical trials designed to generate efficacy and safety data that, if positive, will be used to support the filing of regulatory applications seeking the therapy’s approval.
Bulevirtide conditionally approved in Europe for treating chronic hepatitis D
Viral hepatitis refers to liver inflammation caused by a viral infection. Hepatitis B is the most common form. Hepatitis D is a less common hepatitis type that only occurs in people who are already infected with the hepatitis B virus (HBV).
If the hepatitis D virus (HDV) and HBV infect a person at the same time, the symptoms are usually mild. But in cases where a person is first infected with HBV and later with HDV, the disease commonly leads to long-term complications such as severe liver scarring and damage, known as cirrhosis, or liver failure.
Chronic hepatitis D is the most severe form of viral hepatitis, yet it remains underserved, with limited or no approved treatment options in most countries.
Hepatitis D treatment typically involves interferon therapies, which boost the immune system’s ability to fight the virus, along with antiviral therapies for hepatitis B. Still, HDV often can’t be eliminated this way.
“Chronic hepatitis D is the most severe form of viral hepatitis, yet it remains underserved, with limited or no approved treatment options in most countries,” said Nancy Shulman, MD, Bluejay’s chief medical officer, in the press release.
Gilead Sciences’ bulevirtide is an antiviral medication designed to prevent HDV/HBV from entering human liver cells. It’s conditionally approved in Europe for treating chronic hepatitis D, but U.S. regulators rejected an application seeking a similar approval in 2022.
Brelovitug received breakthrough therapy designation for hepatitis D in US
Brelovitug (formerly known as BJT-778) is an antibody therapy designed to target the hepatitis B surface antigen (HBsAg). This HBV protein is crucial for both HBV and HDV to infect liver cells.
In targeting HBsAg, the therapy aims to reduce the amount of both viruses in the body, enabling the immune system to keep the infection under control and prevent liver damage.
Brelovitug received breakthrough therapy designation for hepatitis D in the U.S. and Priority Medicines and orphan drug designations in the EU. These statuses are intended to expedite the therapy’s clinical development.
Interim data from a Phase 1/2a clinical trial (ACTRN12623000105640) showed that brelovitug lowered blood levels of HDV and alanine aminotransferase (ALT), a marker of liver damage, in people with chronic hepatitis B and D.
In AZURE-2, participants will be randomly assigned to self-administer under-the-skin injections of either brelovitug (300 mg, once weekly) or bulevirtide (2 mg, once daily).
The study’s primary goal is to evaluate the proportion of participants who achieve a complete treatment response, defined as undetectable HDV and ALT normalization, after nearly a year.
In AZURE-1, most participants are treated with brelovitug — at a dose of 300 mg once weekly or 900 mg once monthly — right from the start, while others will delay treatment for six months before starting on 300 mg of brelovitug, once weekly. The main goal is to compare complete treatment response rates between the two groups after six months.
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