Genkyotex S.A. operates as a biopharmaceutical company specializing in nicotinamide adenine dinucleotide phosphate oxidase (NOX) therapies with offices in France and Switzerland.
The company is developing a pipeline of product candidates targeting one or multiple NOX enzymes. The lead product candidate, setanaxib (GKT831), a NOX1 and NOX4 inhibitor has shown evidence of anti-fibrotic activity in a Phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease).
The comp...
Genkyotex S.A. operates as a biopharmaceutical company specializing in nicotinamide adenine dinucleotide phosphate oxidase (NOX) therapies with offices in France and Switzerland.
The company is developing a pipeline of product candidates targeting one or multiple NOX enzymes. The lead product candidate, setanaxib (GKT831), a NOX1 and NOX4 inhibitor has shown evidence of anti-fibrotic activity in a Phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease).
The company’s platform enables the identification of orally available small molecules, which selectively inhibit specific NOX enzymes that amplify multiple disease processes, such as fibrosis and inflammation.
Product Candidates
The company’s lead product candidate, setanaxib, or GKT831, targets inhibition of NOX 1 and NOX 4, which are major drivers of fibrogenesis in multiple organs. They produce reactive oxygen species, or ROS, and modulate signaling by oxidizing signaling proteins, which drive multiple inflammatory and fibrogenic pathways. Setanaxib has shown clinically relevant anti-fibrotic activity in a Phase 2 clinical trial in PBC, a fibrotic orphan disease, despite not achieving its primary endpoint. Based on its Phase 2 results, the company had interactions with the U.S. Food and Drug Administration (FDA) during 2020 regarding the clinical development pathway for setanaxib in PBC, resulting in a confirmed regulatory pathway in the form of a pivotal and potentially registrational Phase 2/3 design incorporating higher dosing than that used in the Phase 2 trial, using alkaline phosphatase, or ALP, as a primary endpoint. The final design and protocol are subject to further feedback and commentary by the FDA. The company plans to initiate the Phase 2/3 trial in the second half of 2021.
Setanaxib is also being evaluated in a Phase 2 clinical trial initiated by researchers investigating type 1 diabetes and diabetic kidney disease. A grant from the United States National Institutes of Health of $8.9 million was also awarded to Professor Victor Thannickal at the University of Alabama at Birmingham to fund a multi-year research program evaluating the role of NOX enzymes in idiopathic pulmonary fibrosis, or IPF, a chronic lung disease that results in fibrosis of the lungs. The core component of this program is a Phase 2 trial with setanaxib in patients suffering from IPF for which the enrollment of a first patient was announced in September 2020.
In October 2020, setanaxib was granted orphan drug designation by the FDA. In December 2020, setanaxib was granted orphan drug designation by the European Commission, in each case for the treatment of PBC. The company is discussing its registration strategy for setanaxib in PBC with the FDA and the European Medicines Agency (EMA).
Based on preclinical animal models, setanaxib has also shown promising results in combination with immunotherapies, specifically checkpoint inhibitors targeting PD-1. The studies have investigated the ability of setanaxib to affect cancer associated fibroblasts, or CAFs, which has resulted in publications of study results indicating that setanaxib might be used to reduce the negative effects of CAFs in certain tumors, including in head and neck cancer. The company is planning to initiate a Phase 2 proof of concept study in head and neck cancer in 2021, involving approximately 30 to 40 patients to further explore setanaxib's anti-fibrotic effects and characteristics related to CAFs.
The company also has a polyvalent platform, Vaxiclase, which is suited to the development of immunotherapies. The company has out-licensed all rights for the use of Vaxiclase as an antigen per se, or GTL003, to Serum Institute of India Pvt. Ltd., or SIIL, the world’s largest producer of vaccine doses, for the development by SIIL of cellular multivalent combination vaccines against a variety of infectious diseases.
In January 2021, the company reported positive data from its Phase 1 clinical trial to evaluate the safety and pharmacokinetics of setanaxib at dosages up to 1,600 mg/day. Based on this positive data, the company plans to initiate a Phase 2/3 trial in PBC, incorporating higher dosing than that used in the Phase 2 trial and using alkaline phosphatase, or ALP, as a primary endpoint in the second half of 2021. The final design and protocol are subject to further feedback and commentary by the FDA. The company plans to initiate the trial in the second half of 2021. In addition, the company plans to initiate a Phase 2 proof-of-concept study in head and neck cancer in 2021, which will study administration of setanaxib in conjunction with immunotherapy targeting cancer associated fibroblasts, or CAFs.
History
Genkyotex SA was founded in 2006.
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