Genkyotex Announces Positive Outcome from Independent SMB’s First Pre-Planned Review of GKT831’s Phase 2 Trial in Primary Biliary Cholangitis

  • Recommendation by Independent Safety Monitoring Board (SMB) to continue trial unchanged following review of safety and pharmacokinetics data
  • Results of interim efficacy analysis from Phase 2 trial expected to be available in Fall 2018

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

Genkyotex (Paris:GKTX) (Brussels:GKTX) (Euronext Paris & Brussels: FR00011790542 – GKTX), a biopharmaceutical company and the leader in NOX therapies, today announced that the independent Safety Monitoring Board (SMB) for its Phase 2 trial of GKT831 for the treatment of Primary Biliary Cholangitis (PBC) held its first pre-planned data review meeting and recommended the continuation of the Company’s trial without protocol amendment. In addition, and as previously indicated, no serious adverse events, liver-related adverse events or drop outs have been reported to date.

“The successful outcome of the first SMB meeting is consistent with the good clinical safety profile of GKT831 observed to date. We are pleased to be able to continue the trial without modification and look forward to the results of the interim efficacy analysis, which are expected this Fall,” said Elias Papatheodorou, CEO of Genkyotex.

The first pre-planned SMB meeting was initiated according to the SMB charter. The independent SMB members reviewed all available clinical, pharmacokinetics, and safety laboratory data, including data from patients who have completed the full 24-week treatment period. The SMB recommended the continuation of the study as per protocol, with no changes or additional data collection required.

This phase 2 trial is a 24-week, double-blind, placebo-controlled study, 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 and allocated to placebo or one of two doses of GKT831 (400mg once a day or 400mg twice a day).

About Genkyotex

Genkyotex is the leading biopharmaceutical company in NOX therapies, listed on the regulated markets of Euronext Paris and Euronext Brussels. 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 is evaluated in a phase II clinical trial in primary biliary cholangitis (PBC, a fibrotic orphan disease) and in an investigator-initiated Phase II clinical trial in Type 1 Diabetes and Kidney Disease (DKD). 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, currently undergoing preclinical testing.

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 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. This partnership could generate up to $57 million in future revenues for Genkyotex, before royalties on sales.4

(4) for the risks associated to this specific partnership with Serum Institute, please refer to the section 4.1.7 of the registration document (“document de reference) registered by the French Markets Authority (the “AMF”) on 27 April 2018 under number R.18-037, “Risks related to development partnerships and to the marketing and sale of product candidates incorporating the Vaxiclase platform”.

For further information, please go to www.genkyotex.com.

Disclaimer

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 (document de reference) registered by the French Markets Authority (the AMF) on 27 April 2018 under number R.18-037., 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.

Contacts

INVESTORS
NewCap
Dušan Orešanský, Tristan Roquet Montégon and Emmanuel Huynh
+33 1 44 71 94 92
genkyotex@newcap.eu
or
MEDIA
ALIZE RP
Caroline Carmagnol & Tatiana Vieira
+33 1 44 54 36 65
genkyotex@alizerp.com
or
US
LifeSci Advisors, LLC
Brian Ritchie, +1-212-915-2578
britchie@lifesciadvisors.com

Contacts

INVESTORS
NewCap
Dušan Orešanský, Tristan Roquet Montégon and Emmanuel Huynh
+33 1 44 71 94 92
genkyotex@newcap.eu
or
MEDIA
ALIZE RP
Caroline Carmagnol & Tatiana Vieira
+33 1 44 54 36 65
genkyotex@alizerp.com
or
US
LifeSci Advisors, LLC
Brian Ritchie, +1-212-915-2578
britchie@lifesciadvisors.com