Repurposing Established Drugs to Create New Treatments
This Algernon Pharmaceuticals Inc. profile is part of a paid investor education campaign.*
Algernon Pharmaceuticals Inc. (CSE:AGN | OTCQB:AGNPF | XFRA:AGW) is a clinical-stage pharmaceutical development company focused on the areas of non–alcoholic steatohepatitis (NASH), chronic kidney disease (CKD), inflammatory bowel disease (IBD), idiopathic pulmonary fibrosis (IPF) and chronic cough. The company is working to advance known, safe and already approved drugs for new disease indications.
Drug development is an extremely long and financially risky process. Developing a newly discovered drug typically takes five to six years before the drug can be deemed safe enough for human testing, and most experimental drugs are never approved for human trials. Algernon Pharmaceuticals’ strategy to find new and groundbreaking uses for drugs that have already been proven safe provides an attractive alternative to the typical new drug development model, With this strategy, Algernon can advance a drug into a phase II study quickly and cost-effectively and with reduced risk of failure due to drug safety issues.
While drug re-purposing has been attempted before, the key value proposition for Algernon is that it has eliminated the risk of generic competition by screening drugs that have never before been approved in the US or Europe. Once a drug is identified, the company investigates it in a globally accepted animal-testing model to identify if it shows promise to treat a new disease completely unrelated to its original purpose. Algernon then files new intellectual property rights and fast-tracks the drug into a phase II trial in the country where it was originally approved. The next step is to move the drug into a USFDA registration. This strategy has the potential to dramatically reduce the time needed to advance through the early phases of drug development.
Algernon has identified four compounds with significant potential for a successful repurposing program. In repeated animal studies, these four drugs have matched or outperformed leading global treatments for the diseases being studied. Algernon is ready to advance all four of its drugs into phase II clinical trials.
Algernon Pharmaceuticals’ Company Highlights
- Planning its first phase II trial for idiopathic pulmonary fibrosis and chronic cough in Q2 2020.
- Has a drug development program based on drug repurposing, which has a much lower risk of fail in human trials as a result of safety issues
- Reduced time and cost to move compounds into a phase II trial due to advancing safe, approved well established small molecules
- Company is advancing compounds that have matched or outperformed leading global treatments in animal studies
- Multi-billion dollar global markets for disease treatments
- Experienced management team and globally recognized medical advisory board
- Capital-efficient business model
NP-120 (Ifenprodil) for Idiopathic Pulmonary Fibrosis & Chronic Cough
Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung condition involving progressive tissue scarring that causes an irreversible decline in lung function. There is currently no treatment that can reduce this fibrosis. IPF has an estimated prevalence of 13 to 20 per 100,000 people worldwide. According to GlobalData, the market for IPF treatments is projected to be worth US$3.2 billion by 2025.
Ifenprodil (NP-120) was developed by French pharmaceutical company Sanofi (EPA:SAN) in the 1990s to treat peripheral circulatory disorders. The drug is no longer available in France but its generic versions remain commercially available in Japan.
Algernon has conducted two independent studies on Ifenprodil, finding that the drug is capable of reducing fibrosis by 56 percent with statistical significance.
A chronic (persistent) cough is one lasting longer than eight weeks in adults, or four weeks in children. Chronic cough can interrupt sleep, cause exhaustion and, in severe cases, can cause serious vomiting, light-headedness and rib fractures. According to IndustryARC™, the cough remedies market size is estimated to be USD$1.40 billion in 2018, growing at a CAGR of 6.64 percent now until 2024.
Ifenprodil showed dramatic superiority over Gefapixant, Merck’s lead phase III trial drug, in a well-accepted, acute cough in-vivo animal study reducing cough frequency by 110 percent over Gefapixant.
NP-178 (Emoxypine) for Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is an umbrella term used to describe conditions that cause chronic inflammation of the digestive tract, including Crohn’s disease and Colitis. These considerations cause ulcers and inflammation in the colon and rectum. Crohn’s and Colitis affect approximately 319 out of every 100,000 people and 249 out of every 100,000 people respectively in North America. The global market for IBD treatments is projected to reach US$14.8 billion by the end of 2025, according to Transparency Market Research.
Emoxypine (NP-178) is currently commonly used in Russia for the treatment of several neurological conditions. As one of the top-selling drugs in the country, Emoxypine is widely available in Russia and Ukraine.
Algernon’s studies on the drug in IBD models highlighted statistically significant activity for both Chrohn’s disease and ulcerative colitis. The drug matched or surpassed the current standard of care treatment, 5 amino salicylic (5-ASA), in these models with no negative side effects. 5-ASA can be highly effective as an IBD treatment, but it has a 50 percent failure rate and alternative steroid-based treatments can have serious side-effects.
NP-160 (Bromantine) for Chronic Kidney Disease
Chronic kidney disease (CKD) is a condition wherein damage inhibits the kidneys’ ability to filter blood, allowing excess fluid and waste to remain in the body which can lead to a range of other health problems. CKD is often a result of fibrosis (scarring of internal tissue). The overall prevalence of CKD in the general population is approximately 14 percent. According to Research and Markets, the global market for CKD-treating drugs is projected to reach US$17.4 billion by 2025.
Bromantine (NP-160) was developed in the Soviet Union as an actoprotector, a drug that increases body stability while working under extreme physical conditions. The Soviets initially used the drug as a performance enhancer for soldiers, cosmonauts and athletes under extreme physical conditions. Bromantine is still commercially available in Russia under the name Ladasten as a treatment for neurasthenia.
In Algernon’s in vivo tests, Bromantine reduced fibrosis in mice by 57.6 percent.
NP-135 (Bemethyl) for Non–alcoholic Steatohepatitis
Steatohepatitis, commonly known simply as liver disease, is a serious condition in which fat accumulates in liver tissue. Steatohepatitis is commonly associated with excessive alcohol consumption, but non–alcoholic steatohepatitis (NASH) affects people who consume little or no alcohol. NASH is the most severe form of non-alcoholic fatty liver disease (NAFLD) and can lead to fibrosis and ultimately liver cancer. NAFLD affects between 80 and 100 million people in the United States alone and 25 percent of NAFLD cases progress to NASH. According to Allied Market Research, the market for NASH treatments is projected to be worth US$21.4 billion by 2025.
Bemethyl (NP-135), like bromantine, was developed in the Soviet Union as a performance-enhancing drug for use by cosmonauts and soldiers in extreme conditions as well as internationally competing athletes. The drug remains commercially available in Ukraine, the Republic of Moldova, and Georgia.
Algernon’s study of bemethyl on lab mice indicated a 1.5 point drop in the NAFLD/NASH score compared to the control group as well as an 84.4 reduction in fibrosis.
Algernon Pharmaceuticals’ Management Team
Christopher J. Moreau—Chief Executive Officer
Christopher J. Moreau is a seasoned business professional in the life sciences sector with a strong background in biotechnology research, business development and a deep expertise in the capital markets. Mr. Moreau was previously President and CEO and Director of a publicly-traded company, and has raised in excess of $13 million to fund research & development for screening tests for prostate cancer, skin cholesterol and type 2 diabetes. He also has over 25 years of senior management experience in private & publicly-traded company environments.
Mark Williams, PhD, MBA—Chief Science Officer
Mark Williams has 15 years of experience in drug and medical device development having repurposed 3 drugs from preclinical studies directly to positive phase II data. He was also the inventor of a recombinant protein and helped oversee its development from manufacturing into phase II trials for his previously NASDAQ traded company.
Medical and Scientific Advisory Board Members
Dr. Arun Sanyal
Dr. Arun Sanyal, MD, is a leading global expert and clinician in the area of chronic liver disease. Dr. Sanyal has developed, mediated and encouraged global liver research as a physician-scientist for 25 years. Currently, Dr. Sanyal is the Vlahcevic Chair of Medicine in the department of Internal Medicine at Virginia Commonwealth University (VCU) and Director of the KL2 program in the Center for Clinical and Translational Research at VCU. Dr. Sanyal’s medical career has spanned the spectrum of translational science in liver cirrhosis, NASH and non-alcoholic fatty liver disease (NAFLD).
Dr. Walter Reinisch
Dr. Walter Reinisch, MD, is a leading global scientific expert and clinician in the area of IBD has joined the Algernon Medical and Scientific Advisory Board. Dr. Reinisch is 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. Dr. Reinisch is a member of the International Organization For the Study of Inflammatory Bowel Disease.
Dr. Martin Kolb
Dr. Kolb is the Moran Campbell Chair and Professor in Respiratory Medicine and Director of the Division of Respirology, McMaster University, Hamilton, Ontario, Canada. He is lead of the interstitial lung disease program, located at St. Joseph’s Healthcare Hamilton, where more than 1,500 patients with different types of fibrotic interstitial lung disorders are seen annually. His major research interests are the mechanisms of lung fibrosis, with a particular interest in the role of growth factors, matrix abnormalities and pulmonary vessel remodeling in disease progression.
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