Repurposing Drugs Reduces Investment Risk. Algernon Pharma Plans Phase 2 Trials for NASH, CKD and IBD

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:

1. Originally a psoriasis drug, Biogen's Tecfidera has become a blockbuster in Multiple Sclerosis therapy.
2. Lupus is benefiting from a new indication of CellCept, originally an organ transplant drug. It was sold for $1 billion.
3. 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