Asceltis receives China IND nod for clinical trials of ASC42 for CHB

Elevating cases of chronic hepatitis B (CHB) has now impelled Asceltis Pharma Inc., a data driven biotech firm in China, to experiment towards developing drugs that can, to some extent, reduce the impact of CHB in the human body.

In light of this, the company recently announced that China National Medical Products Administration produced an Investigational New Drug (IND) approval for its drug candidate- ASC42 to undertake clinical trials for the CHB indication.

For the record, ASC42 is an in-house developed, potent, selective FXR agonist. It is an oral formulation advanced with in-house patent technology, which is considered to be stable at room temperature.

It has been reported that both in-vitro primary human hepatocyte cells and in-vivo HBV/AAV mouse studies, earlier, presented that the ASC42 drug candidate significantly repressed serum hepatitis B antigen and HBV pregenomic RNA. This implies that ASC42 boasts of therapeutic potential to cure CHB.

Reports suggest that as an FXR agonist, ASC42 has exceptional operation against HBV as it prevents the transcription of HBV cccDNA into HBV RNA, in turn repressing the translation of HBV RNA into HBsAg.

Apparently, the ASC42 drug is also likely to reduce HBV cccDNA stability.

It would be crucial to mention that ASC42 is the second investigational new drug of the company for HBV functional cure. Another investigational new drug for HBV cure is ASC22, which is currently in Phase IIb analysis. The study showcased preliminary efficacy and good safety in HBsAg reduction in Phase IIa evaluation.

Commenting on the latest accomplishment, Founder, Chairman and CEO of Asceltis, Dr. Jinzi J. stated that the firm is quite thrilled about ASC42 IND nod for CHB. Dr. Jinzi addressed this achievement as a key milestone for its CHB functional cure pipeline. He further added that the potential synergy between ASC22 and ASC42 is promising for the company’s effort on CHB functional cure.

Source Credit: https://www.prnewswire.com/news-releases/ascletis-received-china-ind-approval-of-its-fxr-agonist-asc42-for-chronic-hepatitis-b-indication-301306416.html