Genkyotex Announces the Dosing of the First Subjects in Its Phase 1 Study With High-dose Setanaxib
30 Juin 2020 - 5:45PM
Business Wire
- The study aims to support the use of high-dose setanaxib in
future clinical trials, including the pivotal registration trial of
setanaxib in primary biliary cholangitis (PBC)
- This Phase 1 study will evaluate setanaxib administered at
doses up to 1,600 mg/day
- Genkyotex anticipates superior efficacy in PBC with a higher
dose
Regulatory News:
Genkyotex (Paris:GKTX) (Brussels:GKTX) (Euronext Paris &
Brussels: FR0013399474 – GKTX), a biopharmaceutical company and
the leader in NOX therapies, today announced the initiation of a
Phase 1 clinical study with high-dose setanaxib in healthy
subjects.
This new Phase 1 study aims to support the inclusion of doses of
up to 1,600 mg/day in future clinical trials, including the pivotal
trial which will support the registration of setanaxib in primary
biliary cholangitis (PBC). The study was approved by the French
Medicines Agency (ANSM) in May 2020.
To date, five Phase 1 and three Phase 2 clinical studies have
been conducted with setanaxib and no safety signal and no dose
limiting toxicity have been observed. In the successfully completed
PBC Phase 2 trial, 800 mg/day achieved consistently greater
efficacy than 400 mg/day across multiple endpoints including
improvements in markers of liver fibrosis, including a rapid
reduction in liver stiffness and markers of collagen turnover.
Superior efficacy was also achieved for fatigue, the main symptom
reported by PBC patients, as well as for the cholestatic markers
alkaline phosphatase (ALP) and gamma glutamyl transpeptidase
(GGT).
Genkyotex recently provided additional clinical data from the
PBC Phase 2 trial highlighting setanaxib’s anti-fibrotic mechanism.
Specifically, setanaxib improved markers of collagen turnover
indicating reduced collagen synthesis and enhanced collagen
degradation in patients with advanced liver fibrosis. These results
provide further mechanistic insights for setanaxib’s anti-fibrotic
activity and provide an explanation for the rapid reduction in
liver stiffness already reported in these high-risk patients.
Considering setanaxib’s excellent clinical safety profile, the
company has decided to explore higher doses and anticipates
superior efficacy based on the dose dependent effects observed in
the Phase 2 PBC trial.
The single ascending dose (SAD) part of the Phase 1 study will
provide pharmacokinetics information for doses up to 1,600 mg.
Subsequently, the multiple ascending dose (MAD) part of the study
will evaluate setanaxib doses of 1,200 and 1,600 mg/day over a
10-day dosing period. A total of up to 54 male and female healthy
subjects will be included in the study.
Upon successful completion of this new Phase 1 study, Genkyotex
plans to include higher doses in upcoming studies.
“We are excited to initiate this study in a timely fashion
despite the COVID-19 pandemics. This study is an important
component of our development plans for setanaxib in multiple
fibrotic indications. In particular, assessing these higher doses
can support our registration strategy for setanaxib in PBC. We plan
to provide further information about our pivotal program soon”,
said Philippe Wiesel, M.D., Executive Vice President and Chief
Medical Officer of Genkyotex.
Next financial press release:
Q2 2020 business update and cash position: July 23, 2020 (after
market)
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 2 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 with IPF scheduled to recruit patients in the
course of 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, 2020 under number 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