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.
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.
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.
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.
Two new lead compoundsfor 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.
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.
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.
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.
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.
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.
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FULL DISCLOSURE: This is a paid article produced by Stockhouse Publishing.