GenKyoTex S.A. Initiates Patient Enrollment Into Phase II Trial Of GKT831 In Primary Biliary Cholangitis

ARCHAMPS, France & GENEVA--()--Regulatory News:

Genkyotex (Paris:GKTX) (Brussels:GKTX) (Euronext Paris & Brussels: FR00011790542 –, a biopharmaceutical company and the leader in NOX therapies, announced today that it has begun enrolling patients into the Company’s Phase 2 clinical trial of GKT831, its NOX1 and NOX4 enzymes inhibitor, in primary biliary cholangitis (PBC). Enrollment initiation at the first investigational center in the U.S. took place following regulatory clearance by the U.S. Food & Drug Administration and local Institutional Review Board. Dosing of the first patient is expected shortly.

Genkyotex is currently working on the activation of a large network of investigational centers participating in this global trial. In total, over 50 centers are expected to be activated in the United States, Canada and several European countries. Interim top-line results from the Phase 2 clinical trial are anticipated in the first half of 2018, and full results are expected in the second half of 2018.

We are pleased to initiate patient recruitment for this promising clinical trial,” said Philippe Wiesel, MD, Executive Vice President and Chief Medical Officer of Genkyotex. “Alleviating progressive liver injury and fibrosis is an important therapeutic objective in patients with active PBC. We are grateful to the global network of experienced investigators who will participate in this important Phase 2 clinical study. We are now focused on delivering trial results over the next 18 months."

The Phase 2 clinical trial is a 24-week, double-blind, placebo controlled, multi-center trial evaluating the safety and efficacy of GKT831 in patients with PBC and inadequate response to ursodeoxycholic acid. A total of 102 PBC patients will be enrolled in this international study and allocated to placebo or one of two doses of GKT831 (400mg once a day or 400mg twice a day). The primary objective of the trial will be to demonstrate therapeutic activity through a reduction of gamma glutamyl transpeptidade, a marker of liver injury, which also reflects oxidative stress. Secondary efficacy endpoints include markers of liver inflammation and injury (CK-18, hs-CRP, ALT), non-invasive markers of liver fibrosis (Enhanced Liver Fibrosis score, transient elastography and circulating collagen fragments).

In addition, the trial will evaluate the effect of GKT831 on bile acid metabolism, itching, autoimmunity, and quality of life. Moreover, the trial will characterize the clinical safety profile and pharmacokinetics of GKT831 in this patient population. An interim analysis will be performed once 90 patients have completed their week 6 visit.

About Genkyotex
Genkyotex is the leading biopharmaceutical company in NOX therapies. Listed on the Euronext Paris and Euronext Brussels markets, Genkyotex is established in France and, via its GenKyoTex Suisse SA subsidiary, in Switzerland. A leader in NOX therapies, its unique therapeutic approach is based on a selective inhibition of NOX enzymes that amplify multiple disease processes such as fibrosis, inflammation, pain processing, cancer development, and neurodegeneration.

Genkyotex’s platform enables the identification of orally available small-molecules that selectively inhibit specific NOX enzymes. Genkyotex is developing a pipeline of first-in-class product candidates targeting one or multiple NOX enzymes. The lead product candidate, GKT831, a NOX1 and NOX4 inhibitor entered a phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease) in the second quarter of 2017. This product candidate may also be active in other fibrotic indications. Its second product candidate, GKT771, is a NOX1 inhibitor targeting multiple pathways in angiogenesis, pain processing, and inflammation, and should enter a phase I clinical study at the end of 2017.

Genkyotex also has a versatile platform, Vaxiclase, that is particularly well-suited to the development of various immunotherapies. A partnership covering the use of Vaxiclase as an antigen per se (GTL003) has been established with Serum Institute of India Ltd (Serum Institute), the world’s largest producer of vaccine doses. This agreement covers territories outside the United States and Europe, and could generate up to $57 million in revenues for Genkyotex, before royalties on sales. It will enable Serum Institute to develop acellular multivalent combination vaccines against a variety of infectious diseases, including whooping cough. The last preclinical milestone foreseen in the agreement was reached in November 2016, opening the path to formal preclinical testing prior to potential clinical development and subsequent commercialization.

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This press release and the information it contains does not constitute an offer or solicitation to buy, sell or hold Genkyotex shares in any country, in particular any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration, exemption from registration or other qualification under the securities laws of any such jurisdiction.

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 registration document filed with the French Markets Authority (the AMF) on 1 April 2015 under number R.15-015, as updated in the Document E filed with the AMF on 31 January 2017 under number E.17-004, 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.

Dušan Orešanský, Tristan Roquet Montégon et Emmanuel Huynh
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