Ascletis Pharma has announced the dosing of the first subject in the Phase III clinical trial of ASC40 plus bevacizumab to treat recurrent glioblastoma (rGBM).
An oral, selective fatty acid synthase (FASN) inhibitor, ASC40 hinders energy supply and interrupts membrane phospholipid composition of tumour cells by hindering de novo lipogenesis (DNL).
FASN is a crucial enzyme that controls DNL.
The multicentre, randomised, placebo-controlled, double-blind trial will assess the safety, progression-free survival (PFS) and overall survival (OS) of ASC40 in rGBM patients in China.
Nearly 180 subjects will be categorised into a 1:1 ratio to either cohort 1 to receive a once a day oral dose of ASC40 plus bevacizumab or cohort 2 to receive placebo plus bevacizumab.
Ascletis anticipates randomising and enrolling approximately 80% of these subjects in the trial by the end of December this year.
According to data from the Phase II trial concluded in the US, individuals with rGBM demonstrated to have an objective response rate (ORR) of 65% on treatment with ASC40 plus bevacizumab.
Furthermore, ASC40 plus bevacizumab offered a complete response (CR) and a partial response (PR) of 20% and 45%, respectively.
Ascletis founder, chairman and CEO Dr Jinzi Wu said: “Dosing the first patient in ASC40 Phase III registration study is a significant milestone for our oncology pipeline.
“We are looking forward to the data from this Phase III study.”
Apart from FASN inhibitors, oncology pipeline of Ascletis includes two oral PD-L1 small molecule inhibitors, ASC61 and ASC63.
Ascletis has submitted an Investigational New Drug (IND) application in the US for ASC61 to treat advanced solid tumours.
Earlier, the company dosed the first participant in Phase II trial of ASC40 for the treatment of moderate-to-severe acne.