Q&A with Christopher J. Moreau CEO of Algernon Pharmaceuticals
04 Junio 2019 - 7:00AM
InvestorsHub NewsWire
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Q&A with Christopher J. Moreau CEO of
Algernon
Pharmaceuticals
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Since donning its new corporate identity earlier
this year, Algernon Pharmaceuticals Inc.(CSE:
AGN, OTCQB:
BTHCF, Forum) has been
busy advancing its research and its
business.
Much
like the classic novel the clinical stage Company derived its name
from, which built its theme around change, Algernon is shifting to
become a phase II clinical trial
Company.
Having changed its name to Algernon
in February 2019, the
corporate shift was intended to align its operation with its main
strategy to be a global leader in the treatment of liver disease,
non-alcoholic steatohepatitis (NASH), chronic kidney disease (CKD)
and inflammatory bowel disease
(IBD).
NASH
is a common liver disease associated with obesity and type-2
diabetes. It occurs when liver fat accumulates with inflammation
and cellular damage, often leading to scarring of the liver and
progress to cirrhosis, liver cancer and eventual liver failure.
There no approved treatments available and it affects roughly 5
per-cent of the U.S. population. As a looming epidemic-level
chronic disease, Algernon is likely on the cusp of a major product
soon to be under significant demand.
In
just under five years from now, it is estimated that the NASH
market will touch $20
billion,
according to recent data gathered by Market Research
Engine.
Meanwhile, the Global IBD Drug Market Forecast
2018-2028 Report shows that the global IBD drug market was
estimated at $6.7 billion in 2017 and will reach $7.6 billion by
2023. Biologic therapies held a 57 per-cent share of the IBD market
in 2017. The antibiotics segment of the IBD market is estimated to
grow at a CAGR of 6.3 per-cent from
2018-2023.
Company CEO Christopher J. Moreau stated in a news
release at the time that the corporate rebranding was - “Based on
the success of our pre-clinical drug development program, we
believe that this change will help to communicate to the market,
our excitement and confidence in our newly established drug
research program.”
We
caught up with CEO Moreau to find out more about each piece of
major news from the first half of the year and see where it is
headed.
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Thanks for taking the time. The Company started the year off with
the announcement that through pre-clinical NASH testing, positive
activity in a NASH animal study with NP-160 was confirmed,
what did this mean for your efforts and how did it guide your
research?
Validating the performance of NP-160, our first
lead compound for NASH, was an important step. It reduced fibrosis
by 42.per-cent in the first animal study we conducted and after
increasing its dose to the maximum, it decreased fibrosis by 59.9
per-cent in the secondary study. This was a very positive sign that
the data was real and
reproducible.
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The major developments continued with the news that its lead NASH
compound NP-135 showed an 84 per-cent reduction of fibrosis. Phase
II of clinical trials look to establish human efficacy. This was
its second pre-clinical study for non-alcoholic fatty liver
disease, what was established
here?
The
results of our pre-clinical NASH research study were very dramatic
with our second lead NASH compound NP-135 which reduced fibrosis by
84.4 per-cent in the animal model we used. To show just how
meaningful that result was, in the same study, Cenicriviroc, a drug
currently in a phase 3 NASH trial and a positive control in our
study, only reduced fibrosis by 59.9 per-cent. NP-135 is showing
very strong anti-fibrotic capabilities, which must be explored
further.
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Sticking with Algernon’s NASH studies, the Company announced in
April that deeper tests into NP-135 revealed a meaningful reduction
of liver hydroxyproline, a key secondary marker of fibrosis. Can
you explain this for
investors?
Liver hydroxyproline, is a biomarker associated
with fibrotic liver disease and its levels in the body can help to
indicate if the disease is progressing. In addition to dramatically
reducing fibrosis in our NASH study, NP-135 also reduced liver
hydroxyproline by 34.6%. In the same study Cenicriviroc reduced
liver hydroxyproline by 29.9%. Its always better if you are able to
show that a compound’s impact on a disease can be measured using
multiple
indicators.
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Two new lead compounds for the possible treatment of chronic kidney
disease CKD were also discovered (NP-160 and NP-251). How
significant were these discoveries to your overall work with this
disease?
There hasn’t been a new treatment approved for CKD
for many years and so to have discovered that we have multiple
compounds that are showing such promise in our animal models is
very exciting. Also, none of our lead compounds is believed at
present to be affecting blood pressure, which is a key target with
the current leading treatments for CKD. So, in addition to being
potential new stand-alone treatments for CKD, the potential is that
they might also be combined with the current standard of care
resulting in an accretive
effect.
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Looking at further research the Company conducted into NP-120 and
NP-251, positive preliminary data from its first idiopathic
pulmonary fibrosis (IPF) study, would mean that Algernon could
begin planning an additional phase II study for its fourth major
global disease, is there any update for investors on
this?
While we are doing additional research on NP-120
and NP-251 and IPF there is nothing to report at
present.
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Algernon has also been growing its Medical and Scientific Advisory
Board. In March Dr. Arun Sanyal, a leading global expert and
clinician in the area of chronic liver disease, was brought on
board. What does he bring to the
table?
In
addition to being a renowned clinician and an award winning
research scientist, Dr. Sanyal also has deep insights into all of
the major compounds that are currently going though clinical
trials. The Company looks forward to working with him on the key
areas of drug efficacy and product positioning as we advance our
lead compounds into human
trials.
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Joining Dr. Sanyal is Dr. Walter Reinish, an expert on the
inflammatory bowel disease (IBD) side and advocate for greater
communication with patients and more robust research, what will his
vision for clinical trials look like for the
Company?
Dr.
Reinisch has a significant depth of experience in clinical trials
and management. He has already had a positive impact on our planned
phase II trial study design, and we believe his approach with
patients will result in more positive enrolment rates in our
studies as well to improve the potential of a successful study
outcome.
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The drug development approach that Algernon is advancing seems
quite distinct from an investment perspective, how does the Company
compare to its peers in this
space?
95per-cent of new drugs fail before they reach
human trials at an average cost of >$30M per compound. Because
of our drug repurposing approach with known safe drugs, Algernon
has over 5 compounds that could be advanced directly into phase II
trials. This was achieved at a fraction of the cost compared with
new drug development. Because of the well-established safety
history of our compounds, the chances we will achieve a successful
phase II trial has increased significantly. A successful phase II
study means very significant value creation for the
company.
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What does the immediate future hold for the Company’s NASH
Trials?
The
immediate future is focussed around securing the resources required
to conduct a minimum of 2 phase II trials, and then focussing on
getting the compounds in the clinic and the trials started. The
announcement of “first patient enrolled” is always a key milestone
to work towards.
Credit: Stockhouse
Publishing
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Copyright © 2019 Algernon Pharmaceuticals, All rights
reserved.
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