This investigator-initiated trial funded by the National Institutes of Health (NIH) aims to evaluate the safety and efficacy of setanaxib in 60 patients
Regulatory News:
Genkyotex (Paris:GKTX) (Brussels:GKTX) (Euronext Paris Brussels: FR0013399474 GKTX), a biopharmaceutical company and leader in NOX therapies, today announced the enrollment of the first patient in the investigator-initiated Phase 2 clinical trial of setanaxib, the Company's lead product candidate, in idiopathic pulmonary fibrosis (IPF). This study is conducted in accordance with the protocol approved by the U.S. Food and Drug Administration (FDA) and relevant Institutional review board (IRB).
The study is being led by Professor Victor Thannickal of the University of Alabama at Birmingham and includes a consortium of five research centers of excellence in the United States. It is fully funded by an $8.9 million grant awarded to Professor Thannickal's teams by the U.S. National Institutes of Health (NIH). The aim of the study is to evaluate the safety and efficacy of setanaxib in 60 IPF patients receiving standard treatment (pirfenidone or nintedanib) over a period of 24 weeks. The dose of setanaxib utilized will be 800 mg/day (400 mg BID), which was shown to achieve superior efficacy and a similarly favorable safety profile compared to 400 mg OD during the Phase 2 trial of setanaxib in primary biliary cholangitis (PBC). Efficacy endpoints include changes in plasma o,o'-dityrosine, a biomarker based on the mechanism of action of setanaxib, as well as standard clinical outcomes that include the 6-minute walk test and forced vital capacity (FVC). Plasma levels of collagen fragments, which could indicate anti-fibrotic activity, and the safety and tolerability of setanaxib will also be evaluated.
Dr. Philippe Wiesel, Executive Vice President and Chief Medical Officer of Genkyotex, says: "We are delighted with the initiation of this Phase 2 trial of setanaxib and would like to congratulate Professor Victor Thannickal and his team for their efforts that have resulted in the enrollment of a first patient despite the challenging COVID-19 ongoing pandemic context. The launch of this Phase 2 trial in IPF highlights the considerable therapeutic potential of setanaxib in multiple fibrotic disorders. IPF is a highly devastating pulmonary disease with no satisfactory therapeutic solution that would slow or reverse its spread while also being well tolerated by patients. Given the anti-fibrotic effects demonstrated by setanaxib in our Phase 2 trial in primary biliary cholangitis and in numerous preclinical models, we are impatient to evaluate its efficacy in this new indication. Should the outcome be conclusive, it would provide additional clinical evidence that NOX enzyme inhibition could become a new paradigm for treating multiple fibrotic diseases and that our product candidate could play a leading role in this field
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that results in fibrosis (scarring) of the lungs. This scarring of lung tissue causes dyspnea (shortness of breath) that worsens over time. The 5-year survival rate for idiopathic pulmonary fibrosis is between 20 and 40%1, i.e. it has a worse mortality rate than many types of cancer.
Setanaxib achieved regression of pulmonary fibrosis in a preclinical model where injection of bleomycin in adult mice results in persistent fibrosis and senescent myofibroblasts resistant to apoptosis. Setanaxib was able to reverse lung fibrosis by deactivating and clearing myofibroblasts through restored sensitivity to pro-apoptotic signals.
Setanaxib showed it had a positive effect on liver stiffness in the Phase 2 study in primary biliary cholangitis (PBC) and the Company is in advanced talks with the regulatory authorities in the United States and Europe regarding a common registration strategy in this indication. Setanaxib is also being evaluated in an investigator-initiated Phase 2 clinical trial in another fibrotic disease, Type 1 Diabetes and Kidney Disease.
About Genkyotex
Genkyotex is the leading biopharmaceutical company in NOX therapies, listed on the Euronext Paris and Euronext Brussels markets. Its unique platform enables the identification of orally available small-molecules which selectively inhibit specific NOX enzymes that amplify multiple disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration. Genkyotex is developing a pipeline of first-in-class 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). Based on its positive Phase II results, a phase 3 trial with setanaxib in PBC is being planned. Setanaxib is also being evaluated in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD). A grant from the United States National Institutes of Health (NIH) of $8.9 million was awarded to Professor Victor Thannickal at the University of Alabama at Birmingham (UAB) to fund a multi-year research program evaluating the role of NOX enzymes in idiopathic pulmonary fibrosis (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 first patient has been enrolled in September 2020. This product candidate may also be active in other fibrotic indications.
Genkyotex also has a versatile platform well-suited to the development of various immunotherapies (Vaxiclase). A partnership covering the use of Vaxiclase as an antigen per se (GTL003) has been established with Serum Institute of India Private Ltd (Serum Institute), the world's largest producer of vaccine doses, for the development by Serum Institute of cellular multivalent combination vaccines against a variety of infectious diseases.
For further information, please go towww.genkyotex.com
Disclaimer
This press release may contain forward-looking statements by the company with respect to its objectives. Such statements are based upon the current beliefs, estimates and expectations of Genkyotex's management and are subject to risks and uncertainties such as the company's ability to implement its chosen strategy, customer market trends, changes in technologies and in the company's competitive environment, changes in regulations, clinical or industrial risks and all risks linked to the company's growth. These factors as well as other risks and uncertainties may prevent the company from achieving the objectives outlined in the press release and actual results may differ from those set forth in the forward-looking statements, due to various factors. Without being exhaustive, such factors include uncertainties involved in the development of Genkyotex's products, which may not succeed, or in the delivery of Genkyotex's products marketing authorizations by the relevant regulatory authorities and, in general, any factor that could affects Genkyotex's capacity to commercialize the products it develops. No guarantee is given on forward-looking statements which are subject to a number of risks, notably those described in the universal registration document filed with the AMF on April 30, 2020 under number D.20-0434, and those linked to changes in economic conditions, the financial markets, or the markets on which Genkyotex is present. Genkyotex products are currently used for clinical trials only and are not otherwise available for distribution or sale
1 Kim DS, Collard HR, King TE (2006). "Classification and natural history of the idiopathic interstitial pneumonias" Proc Am Thorac Soc. 3 (4): 285-292. DOI:10.1513/pats.200601-005TK PMID 1673819. PMC2658683.
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