news
-
30 June 2020Genkyotex announces the dosing of the first subjects in its Phase 1 study with high-dose setanaxib
Genkyotex (Euronext Paris & Brussels: FR0013399474 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced the initiation of a Phase 1 clinical study with high-dose setanaxib in healthy subjects.
This new Phase 1 study aims to support the inclusion of doses of up to 1,600 mg/day in future clinical trials, including the pivotal trial which will support the registration of setanaxib in primary biliary cholangitis (PBC). The study was approved by the French Medicines Agency (ANSM) in May 2020.
To date, five Phase 1 and three Phase 2 clinical studies have been conducted with setanaxib and no safety signal and no dose limiting toxicity have been observed. In the successfully completed PBC Phase 2 trial, 800 mg/day achieved consistently greater efficacy than 400 mg/day across multiple endpoints including improvements in markers of liver fibrosis, including a rapid reduction in liver stiffness and markers of collagen turnover. Superior efficacy was also achieved for fatigue, the main symptom reported by PBC patients, as well as for the cholestatic markers alkaline phosphatase (ALP) and gamma glutamyl transpeptidase (GGT).
Genkyotex recently provided additional clinical data from the PBC Phase 2 trial highlighting setanaxib’s anti-fibrotic mechanism. Specifically, setanaxib improved markers of collagen turnover indicating reduced collagen synthesis and enhanced collagen degradation in patients with advanced liver fibrosis. These results provide further mechanistic insights for setanaxib’s anti-fibrotic activity and provide an explanation for the rapid reduction in liver stiffness already reported in these high-risk patients. Considering setanaxib’s excellent clinical safety profile, the company has decided to explore higher doses and anticipates superior efficacy based on the dose dependent effects observed in the Phase 2 PBC trial.
The single ascending dose (SAD) part of the Phase 1 study will provide pharmacokinetics information for doses up to 1,600 mg. Subsequently, the multiple ascending dose (MAD) part of the study will evaluate setanaxib doses of 1,200 and 1,600 mg/day over a 10-day dosing period. A total of up to 54 male and female healthy subjects will be included in the study.
Upon successful completion of this new Phase 1 study, Genkyotex plans to include higher doses in upcoming studies.
“We are excited to initiate this study in a timely fashion despite the COVID-19 pandemics. This study is an important component of our development plans for setanaxib in multiple fibrotic indications. In particular, assessing these higher doses can support our registration strategy for setanaxib in PBC. We plan to provide further information about our pivotal program soon”, said Philippe Wiesel, M.D., Executive Vice President and Chief Medical Officer of Genkyotex.
Related
Genkyotex Provides Business Update and Reports Cash Position at March 31, 2020
Genkyotex Provides Business Update and Reports Gross Cash Position at December 31, 2019
Genkyotex reports progress of Setanaxib phase 2 investigator initiated trials
Genkyotex provides business update and reports cash position at September 30, 2019
Genkyotex Announces First Half 2019 Results
The Who recognizes Nox Inhibitors as New Therapeutic Class and Approves Setanaxib for GKT831
Genkyotex Announces FDA Approval of Phase 2 InvestigatorInitiated Trial with GKT831 in IPF
Genkyotex’s GKT831 Prevents Multiple Complications of Portal Hypertension in Preclinical Model
Genkyotex Reports Clinical Evidence of Anti-fibrotic Activity by GKT831 in Liver Fibrosis Patients
Genkyotex provides Corporate Update and Reports Cash position at March 31, 2019
Genkyotex Reverse Stock Split Takes Effect
Genkyotex announces 2018 Annual Financial Results and provides Corporate update
Launch of the reverse stock split of Genkyotex shares
Genkyotex provides corporate update and reports cash position at December 31, 2018
Preclinical Efficacy of Genkyotex’s GKT831 in Prostate Cancer Presented at ESUR18 Meeting
Genkyotex provides update on PBC Phase 2 Trial and Reports June 30, 2018, Cash Position
Genkyotex expands License Agreement for Vaxiclase Platform with Serum Institute of India
Genkyotex Announces Leadership Transition
Genkyotex’s NOX1&4 Inhibitor Strategy in Liver Fibrosis Supported by New Preclinical Results