The Company is engaged in advancing a number of repurposed genericized drugs into phase II clinical trials for the global disease areas of NASH, CKD and IBD.
The compounds being advanced by the Company have all performed equal to or better than the positive controls used in the Company’s widely accepted pre-clinical in vivo animal research studies.
Algernon’s business strategy is to fast track a number of its lead compounds into phase II clinical trials as quickly and as inexpensively as possible by leveraging the currently existing regulatory approval and finished product supply in the country of origin where the drugs were originally approved. Conducting off label phase II trials in the drugs’ currently approved market would save the company from having to synthesize the compounds and conduct all of the preclinical toxicology work. This additional work would in comparison, add significant time and costs to the Company’s development timeline and budget.
Based on the results of some of the feasibility studies in progress, the Company believes that conditions exist that could allow the Company to conduct up to four off label phase II trials without having to do any compound manufacturing or additional pre-clinical work. This would include conducting multiple trials for different diseases with the same lead compound. A final decision will be made on which compounds, which diseases and the locations of the phase II trials once all of the feasibility studies are completed.
The Company is planning to conduct a minimum of two phase II clinical trials simultaneously in order to dramatically improve the Company’s potential of success. Since historically up to 50% of phase II trials achieve positive results and up to 33% of successful phase II drugs end up being approved, ensuring the Company is not conducting and relying on a single phase II clinical trial is key part of the current strategy.
Based on the success of the phase II trials, the Company plans to engage in licensing, partnership and or acquisition discussions (as the target) with a number of large pharmaceutical partners. If for whatever reason, a partnership, license or other does not materialize, the Company will explore moving all successful phase II compounds forward into phase III clinical trials.
At present, the Company does not plan to develop a sales team to advance the marketing sales and distribution of any of its lead compounds if such compounds achieve regulatory approval in any given market. The Company’s strategy is to look for moments of inflection where the potential exists to be able to consummate the best possible licensing or partnering deal or acquisition transaction.
The Company is also advancing the development of a POC breathalyzer device that could ultimately be instrumental in the research and development of regulatory approved test(s) that can screen or diagnose various human diseases using breath. The Company is not currently planning to advance this technology beyond the development of a working prototype but will look to license or pattern with a third party to advance the technology to the next development stage.
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