To rapidly advance from laboratory experiments to clinical trials of the selected drug and chosen indications based on "shortcut" regulatory routes, that enable a shorter time from the lab to treating patients.
Our initial focus is on a both rare diseases and on major unmet clinical needs - leveraging FDA Orphan & 505(b)(2) designations and Expedited Pathway programs.
Based on our extensive investigation of pathologies, across multiple animal models, where the metabolism had become dysregulated (i.e. inflamed, iron overloaded and/or infected with bacteria), our PLATFORM has proven successful and effective in treating each of the shortlisted diseases chosen.
The shortlisted diseases were chosen based on technical and commercial criteria and market feedback, including Modes of Action Fit; Need – Orphan (mid-high range); Existing Drugs; Market – Size; Cost of Alternatives (if any); Pipeline of New Drugs in Clinical Trials; Physician – Initial Feedback from “field"; Payers willingness to pay for Treatment, Pharmacoeconomics; Duration of Clinical Study; Patient Availability; Study Design; and Regulatory Consultants Input.
After successfully working with the regulator and other market players and bringing a drug to market, we will pursue the "common" regulatory approval routes for other wide spread indications (such as Psoriasis) with blockbuster drugs.
Type 2 Diabetes – Global Epidemic costing $850 Billion/Year. In many countries - 1 out of 3 people is either Diabetic or Pre-Diabetic! Over 450 Million people worldwide currently have diabetes; 12% of Global health expenditure is spent on diabetes. In the USA - >30 Million have diabetes and additional 89 Million have Pre-Diabetes, over 4,100 new patients are diagnosed DAILY; $322 Billion per year is spent on diabetes, 20% of healthcare costs go to caring for people with diabetes! In China (WHO data), over 10% of all adults – about 110 million people – currently live with diabetes; rates of Type 2 diabetes in China have exploded in the last couple of decades; almost half of all adults in China – close to 500 million people – have prediabetes.
IBD – affects up to 0.5% of the general population. About 1.5 Million people in the USA suffer from IBD, with approximately 30,000 new cases diagnosed each year (mostly Crohn's and Ulcerative Colitis). More than $7 Billion is spent on IBD annually in the USA (direct costs) and in Canada with over 200,000 patients over C$1.2 Billion is spent annually on direct costs. In Europe 2.5-3 Million are estimated to have IBD and direct health-care cost is estimated to be euro ~5 billion annually. IBD has emerged in newly industrialized countries in Asia, South America and Middle East and has evolved into a global disease with rising prevalence in every continent.
Psoriasis – is the most common autoimmune disease in the United States, affecting >7.5 million (~3% of population) with annual costs reaching >$11 Billion. Globally 125 Million people suffer from Psoriasis, which affects both sexes equally. The worldwide prevalence of psoriasis varies considerably; a high prevalence of approximately 11% has been reported in Norway, compared with lower prevalences of 1.3% and 0.1–2% in the U.K. and China, respectively. People with psoriasis are at increased risk for other health conditions: heart disease, diabetes, heart attack, Crohn’s disease, obesity, high blood pressure and depression.