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January 24, 2022

Ascletis doses first patient in Phase III glioblastoma treatment trial

The trial will analyse the safety, progression-free survival and overall survival of ASC40 in rGBM patients in China.

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). 

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

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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. 

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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