Genkyotex Announces Update for Near Term Clinical Development Plan for Setanaxib
22 Gennaio 2021 - 07:46AM
Business Wire
Regulatory News:
Genkyotex (Paris:GKTX) (Brussels:GKTX)
(Euronext Paris & Brussels: FR0013399474 – GKTX), a
biopharmaceutical company and the leader in NOX therapies, today
announced clinical and governance updates.
Clinical update
Following the positive results from the Phase 1 study announced
in January of 2021, which evaluated higher doses of setanaxib in
healthy subjects, Genkyotex is planning to initiate a pivotal Phase
2/3 study in primary biliary cholangitis (PBC), starting in the 2nd
half of 2021, with final design and protocol details subject to
feedback from the US Food and Drug Administration (FDA).
In addition, the Company plans to initiate this year a Phase 2
proof-of-concept study in patients with head and neck cancer. The
trial will evaluate administration of setanaxib, targeting cancer
associated fibroblasts (CAFs), in conjunction with
immunotherapy.
Governance
Dr. Philippe Wiesel, Executive Vice President and Chief Medical
Officer of Genkyotex, has left the Company to pursue new
professional projects. He will remain as a consultant by Calliditas
Therapeutics.
“I would like to thank Philippe for his significant contribution
to the development of Genkyotex over the past years. The Company
has been a pioneer in the development of NOX therapies which, in
combination with promising clinical data and regulatory progress as
well as recent positive Phase 1 data, has translated into
Calliditas Therapeutics showing strong commitment to the
continuation of our development projects. Given the sound clinical
data obtained to date with setanaxib, we are in a very strong
position to create further value through a pivotal trial in PBC
that is expected to start in the 2nd half of this year”, said
Elias Papatheodorou, CEO 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 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