Ascletis Pharma Inc. (HKEX: 1672), an R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), announced on Monday that it has completed enrolment of 120 subjects in the Phase III registration clinical trial of ASC40 integrated with bevacizumab for treatment of recurrent glioblastoma (rGBM).

The product, an oral, selective small molecule inhibitor of fatty acid synthase (FASN), that inhibits energy supply and disturbs membrane phospholipid composition of tumour cells by blocking de novo lipogenesis.

The Phase III registration clinical trial (ClinicalTrials.gov Identifier: NCT05118776), a randomised, double-blind, placebo-controlled, multi-centre clinical trial in China, is intended to assess progression-free survival (PFS), overall survival (OS) and safety of patients with rGBM. Around 180 subjects will be randomized at the ratio of 1:1 to Cohort 1 (oral ASC40 tablet, once daily + Bevacizumab) and Cohort 2 (matching placebo tablet, once daily + Bevacizumab). Based on prespecified interim analysis condition, 120 subjects are expected to lead sufficient events for interim analysis of PFS. The interim analysis is to be carried out after 93 PFS events are observed.

Dr Jinzi J Wu, Ascletis founder, chairman and CEO, said, 'Lipid metabolism is now recognised as an important pathway in cancer. The pivotal role of FASN in lipid metabolism makes it an attractive target in the clinic research. With 120 patients enrolled in the Phase III clinical trial of FASN inhibitor ASC40, we are likely to have sufficient events for the interim analysis of PFS. It's a milestone of the Phase III study and we are looking forward to the results.'