Thursday, March 28, 2024
HomeHealthcareCardiac report and clinical moratorium end for Antios, Assembly Bio HBV consortium

Cardiac report and clinical moratorium end for Antios, Assembly Bio HBV consortium


The quest for a cure for hepatitis B virus infection is leading antiviral drug developers to try new combinations of approved and experimental therapies. Now, the joint effort between Assembly Biosciences and Antios Therapeutics comes after the first patient in a clinical trial developed a cardiovascular problem that led the FDA to suspend further testing.

Assembly Reveals FDA Clinical Suspension and Termination of Collaboration Regulatory filingDoylestown, Pa.-based Antios, the party of record for the clinical trial, said Wednesday that it had observed no signs of safety concerns related to its drug ATI-2173. Nonetheless, the FDA has requested an independent cardiology evaluation of the Antios molecule.

“We do not consider this a treatment-related adverse event; ATI-2173 was generally well tolerated and there were no safety signals involved,” Antios said in an emailed statement. “However, the researchers who conducted this study believe that adverse events may be related to the triple combination regimen of ATI-2173, TDF and vebicorvir.”

TDF refers to tenofovir disoproxil fumarate, a drug from Gilead Sciences, marketed as Viread. The drug’s approved indications include the treatment of chronic hepatitis B. It’s often used as part of an antiviral combination, and it’s one of three components in a triplet that Antios and Assembly are testing. Vebicorvir is a contribution to the conference. This experimental drug is known as a core inhibitor. The small molecule is designed to target the core protein of the hepatitis B virus, which is absent in humans and is key to the viral replication cycle.

Antios drug is an active site polymerase inhibitor nucleotide. The molecule targets the liver and acts on HBV polymerase, a key hepatitis B virus enzyme. By twisting the enzyme’s active site, the drug is designed to produce antiviral activity and inhibit the virus’ DNA.

Antios began working with San Francisco-based Assembly last July. According to the conference’s financial report, each company is responsible for the manufacturing costs of their respective drugs in clinical trials, and they share the other costs of the research equally.

The first patient in the study took the triple therapy on April 27, according to Antios. The 49-year-old woman developed bradycardia and hypotension—slow heart rate and low blood pressure. The problems appeared to be vasovagal or fainting sensations four hours after taking the drug, Antios said. The company added that the patient had fasted for 20 hours, had extensive blood draws and was taking diuretics.

Antios said it provided the FDA with documentation to help it conduct a safety assessment. As of mid-January, 172 people had been exposed to ATI-2173, including 122 healthy volunteers, 42 people with HBV infection, and 8 people with co-infection with HBV and hepatitis D, the company said.

“We saw no evidence of a cardiac safety signal associated with ATI-2173 or its metabolites,” the company said in its email.

But on May 17, the agency suspended the Antios drug. The assembly said in its filing that it was informed of the regulatory action on May 18 and terminated the cooperation agreement on May 20. For its part, Antios said it’s working to address the FDA’s concerns about resuming future clinical trials of its drugs.

Congress has also had its own set of clinical trial setbacks. Last September, the company began ending one of its hepatitis B programs, a different core inhibitor. In the Phase 2 study, one participant showed signs of high levels of liver enzymes, which are signs of drug toxicity.

Public area picture by the Centers for Disease Control and Prevention



Source link

RELATED ARTICLES

Most Popular

Recent Comments