KME Model.
AGI Therapeutics applies its KME (Known Molecular Entities) approach to identify existing drugs or “known molecular entities” with established safety profiles which can be developed and clinically differentiated for new or improved gastrointestinal indications. KME–based products offer distinct advantages in terms of the risk, cost and time associated with the development and regulatory process as compared to new molecular entities.

The key characteristics of KME approach to drug re-profiling are:

	Target drug established and accepted
	Reference existing safety & toxicology
	Re-profiling challenge is to establish: (a) efficacy in new indication (Therapeutic Switch), or (b) differentiated profile within same indication (Improved Therapy)
	Development/Regulatory pathway simplified and shortened
	Reduced development time/cost

Following identification and selection of candidates, AGI develops strategies to emphasize and differentiate the new or improved gastrointestinal ('GI') use. Once we select a known drug for further development as a GI product candidate, we employ a variety of enabling and differentiation strategies to achieve the desired therapeutic profile. In the case of three of our current product candidates (AGI-001, AGI-003 and AGI-006), this involves the development of single stereo-isomers of the parent or racemic drug, while three other product candidates (AGI-004, AGI-010 and AGI-022) employ drug delivery and controlled release approaches.

AGI's intellectual property strategy is based on developing proprietary patent positions on new and/or improved uses and presentations of KME drugs. We seek to establish method of use patent claims where the new or improved therapeutic use is based on:

	chemical forms (e.g. single isomers)
	drug delivery (e.g. release rates or blood levels of drug)
	pharmaceutical forms (e.g. controlled release formulations)