KemPharm, Inc. today announced the nomination of its second pipeline candidate, KP201, based on its proprietary ligand activated therapy (LAT) platform. KP201 is a new chemical entity (NCE) for the treatment of pain with the possibility of reduced abuse potential. KP201 joins lead candidate KP106, which is a novel prodrug candidate in development for ADHD. KemPharm also today announced the closing of a $3.8 million Series B financing round, the proceeds of which will be used to advance both of these candidates through Phase 1 proof of concept studies.
“KemPharm plans to submit an IND to the FDA for our lead candidate, KP106 for the treatment of ADHD, by year end with clinical trials initiating shortly thereafter. This achievement would represent a timeline of less than two years from concept to clinical studies, and we project that the new drug application (NDA) will be filed in the second half of 2012,” said Robert W. Karr, M.D., Chief Executive Officer of KemPharm. “We are therefore very pleased to complete this financing round which will support KemPharm’s strategy to rapidly move our LAT prodrug candidates through Phase 1 clinical trials.”
KemPharm’s LAT platform generates modified versions of FDA-approved drugs by chemically attaching a removable substituent, called a ligand, to the approved drug, resulting in a prodrug that is an NCE with potentially improved therapeutic characteristics based on enhanced pharmacokinetic profiles and other characteristics. The LAT platform also confers significant potential advantages including the creation of new, composition-based intellectual property and the ability to reduce development timelines and costs.