[의학신문·일간보사=김자연 기자] Gilead signed a partnership agreement with Beer Biotechnology for a phase 2 clinical trial of a new drug candidate for hepatitis B treatment. This is particularly noted as a test aimed at functional healing through immunomodulatory and antigen suppression approaches.
In the trial, Gilead’s TLR-8 agonist selgantolimod and Vier’s siRNA VIR-2218 will be used in combination with a commercially available PD-1 antagonist. .
The test objective is to measure the proportion of patients who achieve functional healing based on HBsAg, HBV DNA, etc. In response, the two companies explained that functional healing should strengthen immunity by stimulating the creation of new T cells so that infection can be managed as well as decreased circulating viral protein levels.
On the other hand, even if the current treatment inhibits viral proliferation, if the treatment is stopped due to cccDNA, HBV re-proliferation is possible, and the virus cannot be completely removed.
A phase 2 clinical trial of VIR-2218, released last year, showed a sustained reduction in HBsAg. It was licensed to Beer in 2017 by Al-Naillam and targets the unchanging regions of the X gene across 10 HBV gene types, a treatment that silences all HBV transcription.
The two companies will retain full rights with respect to their respective candidates and will further discuss the possibility of future research according to the test results.