We are developing the following indications for initial development, and the capsulation technology opens the possibility for other therapeutic areas: Atherosclerosis (reduction of plaque formation) and lipid-lowering (statin replacement) Diabetes, Metabolic Disease. The capsulation technology platform will also enable additional application development in therapeutic areas such as Alzheimer’s plaque reduction, Renal and Colorectal Cancer treatment, Wound Healing and Hair Growth.

In preclinical experiments using transgenic mice and rabbits fed a high fat diet, the drug candidate exhibited a superior profile to statins in cholesterol and triglyceride modulation. The drug seemed to prevent and reversed development of atherosclerosis in amanner superior to statins or other drugs (See figure below). There is also evidence that the drug can control blood sugar and regulate related metabolic disorders.

D-PDMP

D-PDMP is a synthetic molecule; analog of ceramide and inhibitor of glycosphingolipid synthesis. We have encapsulated D-PDMP within a biodegradable polymer using our patented protocol. This substantially increased in-vivo longevity and resulted in an order of magnitude gain in efficacy for interfering with multiple diseases including Atherosclerosis, Type II Diabetes and Alzheimer’s.

Agile Life Sciences (ALS) plans to successfully develop new drugs using this drug platform for Atherosclerosis, Type II Diabetes, Alzheimer’s, Renal and CRC patients in addition to use in Wound Care and Hair Loss indications, based on early pre-clinical and research data. Development of these indications would potentially lead to estimated annual sales to be in the multi-billion-dollar range.

This molecule is well tolerated when given up to 10-times the effective dose for several months in experimental animals. In the transgenic mouse model of diabetes, treatment with BPD decreased LDL cholesterol, triglyceride and raised HDL cholesterol. In addition, it decreased glucose level to within the normal range. BDP also increased B-amyloid level in brain tissue in a mice model of Alzheimer’s disease. The existing drugs in the market are unable to achieve these targets.

Atherosclerosis/Coronary Artery Disease

The analysts forecast the global coronary artery disease therapeutics market to grow at a CAGR of 5.17% during the period 2017-2021. The cardiovascular disease therapeutics market, which includes hypertension, dyslipidaemia and thrombotic events, is set to grow from $129.60 billion in 2017 to $141.40 billion in 2021 at a compound annual growth rate (CAGR) of 2.2%.

Diabetes/Metabolic Disease

According to the International Diabetes Federation and other major professional bodies, the global adult population of individuals with diabetes (types 1 and 2) was around 415 million in 2015, and is predicted to rise to 642 million by 2040. The global prevalence of diabetes among adults over 18 years of age has risen from 4.7% (108 million) in 1980 to 8.5% in 2014. The global diabetes market should reach $155 billion by 2021 from $125 billion in 2016 at a compound annual growth rate (CAGR) of 4.4%, from 2016 to 2021. Non-insulin medications represent a majority, $67 billion of that $125 billion total in 2016.

Lipid Lowering/Statins

The global market for lipid lowering agents was estimated at $28.7 billion in 2017, and forecasted to grow to $31.8 billion and with a CAGR of 2.1% to reach $29.25 billion by 2022. The global statin market 2019-2023 is expected to have an incremental growth of around $1.65 billion from 2019-2023, accelerating at a CAGR of more than 2%.

Alzheimer’s Disease

The global Alzheimer’s Disease (AD) market worth $2.9 billion in 2016 is set to reach $14.8 billion, rising at an compound annual growth rate (CAGR) of 17.5%, across the *7Bn mark by 2026.

Intellectual Property

Agile Life-Sciences has obtained a license and associated patents for exclusive right to D-PDMP from John Hopkins University. We will take the compound from its present pre-clinical status through IND submission into a Phase 1A/B clinical studies,. We have created a patent strategy in addition to plans for filing for multiple method of use patents.