Chinese biotechnology company Ascletis Pharma has enrolled all 120 patients in its Phase III clinical trial of ASC40 in combination with bevacizumab for the treatment of recurrent glioblastoma (rGBM).
The placebo-controlled, double-blind study is designed to assess the safety, overall survival and progression-free survival (PFS) of rGBM patients who are given the combined therapy.
A total of 180 patients aged 18 years and older with histologically confirmed glioblastoma will be divided into two cohorts.
The first cohort will receive an oral ASC40 tablet plus bevacizumab once daily, while the second will be given a matching placebo tablet combined with bevacizumab once a day.
Based on the pre-specified interim analysis conditions, 120 patients are likely to experience the results needed to arrive at an interim analysis of PFS.
Ascletis Pharma plans to carry out an interim analysis once 93 PFS events have been observed.
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Ascletis Pharma founder, chairman and CEO Dr Jinzi J Wu said: “Lipid metabolism is now recognised as an important pathway in cancer.
“The pivotal role of fatty acid synthase (FASN) in lipid metabolism makes it an attractive target in the clinic research.”
The selective FASN inhibitor ASC40 inhibits energy supply and disrupts tumour cells’ membrane phospholipid composition by blocking the de novo lipogenesis pathway.
In addition to rGBM, ASC40 is developed for the treatment of acne and non-alcoholic steatohepatitis (NASH).
Ascletis Pharma focuses on developing therapies for viral diseases, NASH and oncology.
The company’s other drug candidates include ASC61 for advanced solid tumours, ASC22 for chronic hepatitis B cure and ASC41 for NASH.
Earlier this year, Ascletis received approval from the US Food and Drug Administration and China’s National Medical Products Administration for a Phase IIa clinical trial of ASC10, its drug candidate for respiratory syncytial virus infection.