Genkyotex announces positive Phase 1 results demonstrating a favorable safety and pharmacokinetic profile of high-dose setana...
18 Gennaio 2021 - 8:00AM
Business Wire
Regulatory News:
Genkyotex (Paris:GKTX) (Brussels:GKTX) (Euronext Paris &
Brussels: FR0013399474 – GKTX), a biopharmaceutical company and
leader in NOX therapies, today announced positive Phase 1 data
demonstrating a favorable safety and pharmacokinetic profile of
high-dose setanaxib in healthy subjects.
The study showed that setanaxib was well tolerated at doses up
to 1,600 mg/day, and displayed generally dose-proportional
exposure. No safety signal and no dose limiting toxicity were
identified across the doses tested, in a total of 46 healthy adult
male and female subjects.
These results support the evaluation of substantially high
doses, up to 1,600 mg/day, and provide an opportunity to pursue a
pivotal clinical trial in patients with primary biliary cholangitis
(PBC).
Previously, doses up to 800 mg/day were evaluated in a 24-week
Phase 2 trial in PBC patients. In that trial, setanaxib dosed at
800 mg/day achieved reductions in markers of cholestasis including
alkaline phosphatase, and in multiple non-invasive markers of liver
fibrogenesis including liver stiffness and PRO-C3 and C3M.
Significant improvement in fatigue was also achieved. At the same
time, all doses tested were safe and very well tolerated with no
safety signal compared to placebo.
“The results of this new phase 1 study confirm the excellent
safety profile of setanaxib over a broad dose range. Moreover, the
dose dependent effect observed in the previous Phase 2 study,
together with the increased exposure achieved in this study, and
give us the potential to launch a pivotal trial in PBC,” said
Elias Papatheodorou, CEO of Genkyotex.
As a reminder, following a friendly takeover bid initiated by
Calliditas Therapeutics AB (publ) on Genkyotex, the results of
which were announced on December 17, 2020, Calliditas Therapeutics
AB now holds 86.24% of the share capital and theoretical voting
rights of Genkyotex.
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 to
www.genkyotex.com
Disclaimer
This announcement does not constitute an invitation to
participate in the on-going tender offer on Genkyotex shares or to
tender Genkyotex’ shares in or from any jurisdiction in or from
which, or to or from any person to or from whom, it is unlawful to
make such invitation under applicable securities laws. The
distribution of this announcement in certain jurisdictions may be
restricted by law. Persons into whose possession this announcement
comes are required to inform themselves about, and to observe, any
such restrictions.
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.
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GENKYOTEX Alexandre Grassin CFO Tel.: +33 (0)5 61 28 70
60 investors@genkyotex.com NewCap Dušan Orešanský Tel.: +33
1 44 71 94 92 genkyotex@newcap.eu