Repurposing
Drugs
Reduces Investment Risk.
Algernon Pharma
Plans
Phase 2 Trials for NASH, CKD and IBD
Time to put down your
Cannabis and Crypto research, gentle investor. Let's talk biotech:
Biotech with outstanding potential.
May 23, 2019 -- InvestorsHub
NewsWire -- via Bob Beaty -- The market potential of the
Algernon Pharma (CSE: AGN, OTC: BTHCF XFRA:
AGW) story is that the
Company already has the ingredients - the people, procedures and
potential - to garner widespread and global investor interest. Most
biotech ventures, indeed, most small companies, tend to present
significant risk. For investors, Algernon management spends as much
time mitigating risk as realizing success.
Why Algernon?
-
A planned AGN Phase 2 drug
demonstrated better (84.4%) efficacy in the reduction of fibrosis
in a NASH (Non–alcoholic Steatohepatitis) study
than the market's leading Phase 3 candidate (59.9%) in early
research.
-
For chronic kidney disease (CKD) a
drug that showed in Algernons's key research study, a 57%
improvement over current therapy Telmisartan
-
For inflammatory bowel disease (IBD)
including Crohn's disease reducing severity as well as 50% more
effectively than 5-ASA for Colitis, a markedly reduced
severity.
The great news is that you won't
have to wait 10 plus years, which is the average timing of a drug
approval with no assurance of success. Tick-tock goes the
20-year patent clock which starts from the moment of FDA
filing.
NB: Phenotypic
screening is best described as testing a molecule in
cells, isolated tissues or organs, or animals, to see whether it
causes the desired effect. The drugs pathways, target and the
actual mechanism by which the drug produces its effect is often
determined at some future point as was the case with both aspirin
and metformin.
Profiting
from
Success,
And Failure.
AGN tests drugs already successful
as therapies for illnesses completely different than the initial
approval for another serious condition.
The preclinical phase, the longest,
most risky (95% fail) and most expensive part on the road to
approval is completed. Someone else paid for that.
As well, candidates can also come
from abandoned drugs initially developed for another therapeutic
use. These abandoned drugs can be available to other groups
(and the data) to test for other afflictions,
which profoundly reduces the approval time; it's called
repositioning.
A recent MIT study puts the
successful drug approval number at 14 percent. Approval rates
ranged from a high of 33.4 percent in vaccines for infectious
diseases to 3.4 percent for investigational cancer treatments.
Previous estimates placed overall success rates, from Phase I
through to FDA approval, between 9 and 11 percent. Marginally good
news. But it gets better.
Lowering the odds against and
shortening the time to approval benefits everyone. The sponsor
company, investors and most importantly, patients suffering from
some progressive diseases resulting in serious debilitation or
death. The process is called the Drug Repurposing
Strategy.
"Algernon is in the planning stages for
a minimum of 2 separate Phase II clinical trials; any of which
could rapidly change the perception and potential of these
drugs", states Christopher
J. Moreau, CEO. "While these diseases
may not have the public profile of
some well-known
Cancers, the potential for
NASH therapeutics is actually a far larger market.
Algernon has specifically
targeted billion-dollar global markets for 3 key diseases where
there is a dramatic and/or unmet need for new treatment
options."
NASH (Non–alcoholic
Steatohepatitis)
by The Numbers
AGN's lead drug NP-135 targets non–alcoholic
steatohepatitis (NASH), a
serious condition in which fat accumulates in liver tissue in
people who consume little or no alcohol. It is the most severe form
of non-alcoholic fatty liver disease ("NAFLD"), which in some
individuals can progress to fibrosis (scarring) and ultimately
hepatocellular carcinoma (liver cancer).
NASH differs from the simple accumulation
of fat in the liver, which can be a completely benign condition.
But up to 20% of adults with NASH develop cirrhosis and up to 11%
may experience liver-related deaths. Many individuals develop
chronic liver failure and require liver transplantation.
About 3 to 12 percent of
adults in the United States have NASH.
Currently, there are no US FDA approved treatments for NAFLD or
NASH.
Allied Market Research's article
"Global Opportunity Analysis and Industry Forecast,
2021-2025," values the global NASH market at $1.17
Billion in 2017 and is expected to reach $21.4 Billion by
2025.
That's a CAGR of 58.4% from 2021 to 2025.
Investment Potential
Even though these stocks don't get
much attention, consider this: Madrigal Pharma (MGDL) a clinical-stage biopharmaceutical
company has therapy candidate MGL 3196 for the treatment of NASH.
Targeting a
specific thyroid hormone receptor pathway in the liver, it has
conducted Phase 2 trial and is planning a Phase 3. While no
approvals yet, the shares were US$15 in late 2017, US$316.00 in
June 2018 and US$100 a share May 2019. Current market cap is
US$1.55 billion.
By comparison, Algernon
Pharma, which is
planning/approaching Phase 2 trials for therapies for several
diseases including NASH, is trading at a modest C$0.22 a share with
a market cap of C$12.5 million. Do the math. Madrigal's history
could well foreshadow Algernon's future growth and
advancement.
Investors have to understand that
moving to Phase 2 trials is analogous to moving from 6-9 on the
Richter scale. Every point on the earthquake index is not marginal,
but 33% greater than the previous number. So, it is with drug
trials.
Algernon's
Chief Science Officer, Dr. Mark Williams developed AGN's drug
pipeline through drug repurposing, the process of discovering new
therapeutic uses for existing drugs. Repurposing offers several
benefits over traditional drug development including a reduction in
investment and risk, shorter research periods and a longer active
patent life.
Dr. Williams
states; "The potential 8 to10 years saved in the approval process
of repurposed drugs, has several benefits. First, the process can
bring drugs to those suffering from diseases faster than those
currently having limited or no therapeutics, such as NASH. Second,
the extended patent life positively impacts the Company. I'm very
hopeful that the lead candidates for which we are planning the
Phase 2 trials, could result in therapies for all three diseases,
NASH, CKD and IBD."
He
continues, "All Algernon research studies and statistical review of
the data were conducted by 3rd party contract research
organizations. The studies were well designed with proper positive
controls, the gold standard for treatment in the disease being
screened."
Nash:
Potential
$35
Million
Market
Do not for a
moment dismiss the importance of these efforts. The growth profile
for NASH in the near future as noted is frightening; particularly
within a growing and aging population. To relieve suffering and
avoid deaths from cirrhosis is a critical and noble
pursuit.
NASH Phase 2 Candidates
Cenicriviroc
(40 mg/kg, QD) both a positive control and comparator arm in the
study showed a 1.5-point drop in the NAFLD/NAS score vs controls
(p<0.01) and 54.1% (p<0.0001) reduction in fibrosis area
compared to controls as measured by Sirius Red staining.
Algernon's compound NP-135 (200
mg/kg, QD) showed a 1.1-point drop in the NAFLD/NAS score vs
controls (p>0.05) and an 84.4% reduction (p<0.0001)
in fibrosis area.
NP-135 also showed significant
anti-fibrotic activity in a unilateral urinary obstruction (UUO)
model of chronic kidney disease (CKD), reducing fibrosis by 52.1%
(p<0.000001).
CKD (Chronic Kidney Disease) potential $17.5 billion
market
Once the
body's internal waste filter system fails, compromising the release
of waste from the body, a plethora of issues result in varying
stages of decline. Found early there are therapies but left
untreated options fall to dialysis and transplant at Stage 4-5. (5
being end stage which is never good).
Phase 2 Candidates
Telmisartan (3mg/kg), a positive
control, reduced fibrosis by 32.6% (p<0.001).
Cenicriviroc (40 mg/kg) a CCR2/5
chemokine receptor antagonist with reported anti-fibrotic activity,
reduced fibrosis by 31.9% (p=0.00032).
Algernon's NP-160 (40 mg/kg) reduced
fibrosis by 57.6% (p <0.000001). NP-160 was also previously
reported to be anti-fibrotic in a mouse model of non-alcoholic
steatohepatitis (NASH).
IBD (Inflammatory
Bowel Disease)
potential $9.5 billion market
Crohn's
Data from the latest pre-clinical
animal in vivo study demonstrated statistically
significant improvements in multiple measurements over multiple
time points relevant to CD including:
-
Body weight (p<0.001), occult
positivity (p<0.05), colon weight (p<0.05), colon length
(p<0.001) and the colon weight/length ratio
(p<0.001).
-
Algernon's NP-178 compared very
favourably to the control, 5-ASA, the current standard of care for
IBD.
-
No negative side effects were
observed.
Colitis:
Data from the latest pre-clinical
animal in vivo study demonstrated statistically
significant improvements in multiple measurements over multiple
time points relevant to ulcerative colitis including:
-
Body weight, stool consistency,
colon length and weight ratios and occult positivity (p
-
NP-178 compared very favourably to
the control, 5-ASA, the current standard of care for
IBD.
-
No negative side effects were
observed.
The Bottom Line for Investors (and Patients)
-
Repurposing approved drugs for other
disease applications cuts potential time to FDA approval/client
usage in half. Also, it is much more capital efficient; another
party has spent the initial development capital which can approach
half a billion dollars.
-
This jumpstart on safety, efficacy
and formulation lowers investment risk and time to market
significantly.
-
Results in human beings can be known
well ahead of the traditional 'ground up' approval
process.
-
Profitability is improved as there
will be, on approved drugs, roughly 6 years of extra patentable
sales.
Examples of repurposed drugs and
impressive investor development activity:
-
Originally a psoriasis drug,
Biogen's Tecfidera has become a blockbuster in Multiple Sclerosis
therapy.
-
Lupus is benefiting from a new
indication of CellCept, originally an organ transplant drug. It was
sold for $1 billion.
-
Once notorious morning sickness drug
Thalidomide has emerged as a potential blockbuster for Cancer
treatment.
Needless to say, Top tier scientific
and medical
expertise is key.
Currently Algernon's Scientific
Advisory Board includes Dr. Walter Reinisch,
a leading global
scientific expert and clinician in the area of IBD as well
as a founding
member of the European Crohn's & Colitis Organization and was
assigned as an honorary member after having contributed in various
positions. He was active in the Scientific and Public Affairs
Committee of the United European Gastroenterology and headed the
Austrian IBD Study Group.
As well, Dr. Arun Sanyal,
MD, a
leading global expert and clinician in the area of chronic liver
disease. His medical career has spanned
the spectrum of translational science in liver cirrhosis, NASH and
non-alcoholic fatty liver disease (NAFLD), with a particular focus
on obesity and cardiovascular effects related to liver
disease. In 2018
Dr. Sanyal was awarded the prestigious Distinguished Achievement
Award from the American Association for the Study of Liver
Diseases: The award signifies 30 years of exemplary international
research.
Conclusion
Investors, of course, need to make up their own
minds. That said, the provenance of the technology, the management,
research and medical expertise all conspire to bring these
therapies forward. Given the aging demographics over the next ten
to twenty years, the timing is likely right on a number of fronts,
not the least of which may well be as an investor.
Author: Bob Beaty
Utilizing the power of the Internet for more than 20 years to
vastly improve all aspects of financial communications, Bob has
consistently pioneered new methods such as content marketing and
social media to augment or replace traditional media.
Investor Contact: Christopher J.
Moreau CEO
Algernon
Pharmaceuticals
https://algernonpharmaceuticals.com
SOURCE: Bob Beaty
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