Redx Pharma plc New in vivo data on ROCK2 (6903P)
February 12 2019 - 2:00AM
UK Regulatory
TIDMREDX
RNS Number : 6903P
Redx Pharma plc
12 February 2019
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REDX PHARMA PLC
("Redx" or "the Company")
New in vivo data suggests ROCK2 has broad potential in
fibrosis
First-in-man studies, targeting NASH, planned for 2020
Alderley Park, 12 February 2019 Redx (AIM: REDX), the drug
discovery and development company focused on cancer and fibrosis,
announces promising preclinical efficacy data for its lead
selective ROCK2 compound.
Redx reports new data from three independent preclinical animal
models of lung, kidney and liver fibrosis, which show that the
Company's lead ROCK2 compound, dosed therapeutically once fibrosis
is initiated, was able to suppress collagen deposition and pathways
associated with fibrosis, indicating that selective ROCK2
inhibition can have an impact on established fibrosis. The data
from separate studies suggest that Redx's compound possesses a
suitable pharmacokinetic profile for an orally bioavailable drug
and has a low propensity to inhibit key drug metabolising
Cytochrome P450 enzymes, making it less likely to interact with
other drugs. The data from these studies will be presented later in
2019 at a scientific meeting.
Following final safety evaluations, the Company plans to
nominate a drug candidate for the ROCK2 programme by mid 2019. If
nominated for development, the novel selective ROCK2 inhibitor will
be developed as an orally administered, first-in-class treatment
for the non-alcoholic steatohepatitis (NASH) with first-in-man
studies commencing in 2020. NASH is a progressive disease of the
liver caused by a build-up of fatty deposits leading to
inflammation, tissue damage, tissue remodelling and fibrosis,
reducing the metabolic function of the liver. There are currently
no approved treatments for NASH and there is a clear need for new
therapies.
Dr Richard Armer, Chief Scientific Officer, Redx Pharma plc
commented: "ROCK2 plays a central role in metabolic and fibrotic
disease. Generating highly selective ROCK2 inhibitors, without the
significantly limiting hypotension observed with systemic use of
existing non-selective ROCK1/2 inhibitors, has been a key research
challenge. We are very encouraged to generate a highly selective
ROCK2 inhibitor series where the lead compound has demonstrated
anti-fibrotic effects pre-clinically in a broad range of organ
models without any observed toxicity."
Lisa Anson, Chief Executive Officer, Redx Pharma plc added: "We
are encouraged by the pre-clinical data announced today by Redx.
Liver fibrosis associated with NASH remains a condition with a
clear unmet medical need and we hope that Redx's research into
ROCK2 inhibition progresses into the clinic, potentially producing
further data which could lead to a new treatment option for liver
fibrosis patients."
For further information, please contact:
Redx Pharma Plc T: +44 1625 469
920
Lisa Anson, Chief Executive Officer
Richard Armer, Chief Scientific Officer
Cantor Fitzgerald Europe (Nominated Advisor & T: +44 20 7894
Joint Broker) 7000
Phil Davies
WG Partners LLP (Joint Broker) T: +44 20 3705
9330
Claes Spång/ Chris Lee/ David Wilson
FTI Consulting T: +44 20 3727
1000
Simon Conway/Stephanie Cuthbert
About Redx Pharma Plc
Redx is a UK based biotechnology company whose shares are traded
on AIM (AIM:REDX). Redx's vision is to become a leading biotech
focused on the development of novel precision medicines that have
the potential to transform treatment in oncology and fibrotic
diseases.
If you would like to sign up to regular alerts from Redx Pharma,
please follow this link
https://www.redxpharma.com/investors/email-alerts/
About NASH (Non-alcoholic Steatohepatitis)
NASH is an inflammatory and fibrotic disease of the liver that
develops following non-alcoholic fatty liver disease (NAFLD) - a
condition where fatty deposits build-up in liver tissue. It is
estimated around 25-30% of adults in the developed world have
NAFLD, with fatty liver often caused by diabetes, obesity, poor
diet and lack of exercise. Whilst lifestyle changes can reverse
NAFLD in the early stages, this goal is unachievable for most
patients, and the progressive inflammation leads to tissue
remodelling and fibrosis to the extent where the disease is no
longer reversible with changes in patient lifestyle. Fibrotic
tissue build-up results in loss of metabolic function in the liver
and reduced blood flow, known as NASH. NASH progresses through
different stages, each with increasing severity. In 2016, the
prevalence of NASH F1-F3 worldwide was approximately 44 million
with numbers expected to rise to 67 million by 2030(1) . In the
final stages (F4), patients have a condition known as cirrhosis, a
severely debilitating disease caused by a heavily scarred liver
with minimal function remaining. The worldwide prevalence of F4
cirrhosis was 3.6 million in 2016 and is set to more than double to
8.2 million by 2030(1) . These cirrhosis patients are also at high
risk of developing hepatocellular carcinoma (HCC), the third
leading cause of cancer deaths worldwide. There are currently no
approved treatments for NAFLD or NASH and there is a need for new
therapies to address these diseases and specifically the treatment
of fibrosis that causes loss of liver function.
About ROCK2 (Rho-associated protein kinase 2) inhibitors
ROCK2 is an intracellular kinase with multiple cellular
functions. ROCK2 signalling plays a key role in both the
inflammatory component and the tissue re-modelling that drives
disease progression in many fibrotic conditions. ROCK2 has been
shown to be up-regulated in acute inflammatory injury and in
chronic diseases such as diabetes and metabolic syndrome.
Furthermore, ROCK2 is upregulated in models of liver fibrosis and
been shown to modulate activation of the hepatic stellate cells,
the central drivers of fibrosis in the liver. Targeting ROCK2 in
fibrosis is a clinically validated approach with Kadmon's KD025, a
ROCK2 inhibitor in clinical development for IPF and cGVHD. However,
this compound is potentially limited by its interaction with
Cytochrome P450 enzymes which have led Kadmon to undertake clinical
drug-drug interaction studies. The Redx ROCK2 selective inhibitor
compound has a good ADME profile with a low propensity to inhibit
key drug metabolising cytochrome P450 enzymes which is encouraging
for clinical use in co-administration with concomitant medications
in conditions such as NASH.
1. Estes et al, Journal of Hepatology, 2018;(69),896-904.
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