LAT™ Prodrug Platform
KemPharm's strategy is to employ its LAT™ (Ligand Activated Therapy) platform technology to discover and develop NME prodrugs that improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety. KemPharm’s intent is to develop prodrugs that have improved properties over approved drugs and address unmet medical needs in large, established markets.
We use our LAT™ platform technology to create NME prodrugs by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. When combined with the parent drug, our ligands create prodrugs designed to have improved drug attributes while maintaining efficacy equivalent to the parent drug. Once administered, targeted human metabolic processes, such as those in the GI tract, separate the ligand from the prodrug and release the parent drug, which can then exert its therapeutic effect.
The ligands that we typically use have been demonstrated to be safe in toxicological studies or have been granted Generally Recognized as Safe (GRAS) status by the FDA. Further, since our prodrugs are chemical successors of the parent drugs, they are considered to be NMEs and thus may be eligible for protection by composition-of-matter patents.KemPharm has employed its LAT™ prodrug platform to create a portfolio of product candidates that we believe will offer significant improvements over FDA-approved and widely prescribed drugs.
Selected KemPharm NME Prodrug Product Candidates
|Product Candidate||Parent Drug||Development Status||Next Milestone||Potential NDA Submission|
|KP415||Methylphenidate (ER)||Clinical||PK + Efficacy Data||2018|
|KP484||Methylphenidate (ER)||Clinical||PK + Efficacy Data||2019|
|Apadaz™||Hydrocodone/APAP||NDA Resubmitted||PDUFA (Feb. 23, 2018)||Completed|
|KP201/IR||Hydrocodone||Clinical||IN HAL Data||2018 with Priority Review|
|KP511/ER||Hydromorphone||Clinical||POC in ER Formulation||2019 with Priority Review|
|KP511/IR||Hydromorphone||Clinical||HAL + BE Data||2019 with Priority Review|
Multiple CNS Disorders