Arbutus Biopharma moves to terminate development of chronic hepatitis B therapy after trial failure
pharmafile | October 4, 2019 | News story | Medical Communications, Research and Development | Arbutus Biopharma, hepatitis B, pharma
Arbutus Biopharma has announced its decision to terminate the development of its oral capsid inhibitor, known as AB-506, in the treatment of chronic hepatitis B (CHB).
“We have observed two cases of acute hepatitis in our Phase 1a 28-day clinical trial in healthy volunteers. Consequently, the clinical trial and further development of AB-506 have been stopped,” commented William H Collier, President and Chief Executive Officer of Arbutus.
Use of the drug, which reached the Phase 1a/1b clinical trial stage, was shown in July to be associated with mean reductions in HBV DNA and HBV RNA levels after 28 days of treatment. During the trial, four patients were found to have experienced Grade 4 alanine aminotransferase flares, though these normalised after treatment was completed or discontinued.
“The two subjects are experiencing resolution of their acute hepatitis. We will continue to follow them and the other study participants, as safety is our highest priority at Arbutus,” said Dr Gaston Picchio, Chief Development Officer of Arbutus. “We intend to present results from the AB-506 Phase 1a/1b clinical trial along with further details regarding the two cases of acute hepatitis at an appropriate scientific meeting later in 2019.”
Dr Michael J Sofia, Chief Scientific Officer of Arbutus, added: “While we are disappointed in these recent clinical findings, we have a number of oral follow-on capsid inhibitor compounds with distinct chemical scaffolds that we believe have the potential to contribute to the inhibition of HBV replication as part of a combination regimen. Our objective is to select one of several lead compounds for IND-enabling studies by December of this year.”
The decision means that Arbutus will no longer seek to initiate a study combining AB-506 with its RNA interference (RNAi) therapeutic AB-729 which was die to go ahead in the second half of 2020.
Matt Fellows
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