[ad_1]
— Gannex is expected to complete the Phase II trial in 100 patients by the end of 2022.
— Gannex intends to soon start a Phase III trial in Chinathe US and European Union after the completion of the Phase II study in China.
— An epidemiology study in China in 2010 showed that there were approximately 656,000 PBC patients in China including 440,000 in females over age 40. An epidemiology study in the US indicated that there were approximately 120,000 PBC patients in the US in 2014.
SHANGHAI, April 10, 2022 /PRNewswire/ — Gannex Pharma Co., Ltd. (“Gannex”), a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) announces today the first patient dosed in the Phase II clinical trial of ASC42 to treat patients with primary biliary cholangitis (PBC).
The Phase II study (ClinicalTrials.gov Identifier: NCT05190523) consists of three ASC42 active treatment arms (5 mg, 10 mg and 15 mg) and one placebo control arm at the ratio of 1:1:1:1 and is expected to enroll a total of 100 patients who have an inadequate response to or are unable to tolerate Ursodeoxycholic acid (UDCA). The treatment duration is 12 weeks and the study is expected to be completed by the end of 2022.
The protocol of Phase III clinical trial in 210 PBC patients was approved in November 2021 by China National Medical Products Administration (NMPA). After the completion of the Phase II clinical trial, Gannex will soon initiate the Phase III trial after the communications with China NMPA in terms of drug registration related matters such as Chemistry, Manufacturing and Control (CMC ) and toxicology studies.
ASC42 is an in-house developed, novel non-steroidal, selective, potent Farnesoid X receptor (FXR) agonist with best-in-class potential and global intellectual property. The data from the US Phase I trial of ASC42 indicated there was no pruritus observed during 14-day treatment of…
Full story available on Benzinga.com
[ad_2]
Source link
