JT Pharmaceuticals, Inc. — Department of Health and Human Services SBIR Phase II: 101

Description

DESCRIPTION provided by applicant Neuropathic pain management is a major unmet clinical need Classically used medications opioids and non opioids NSAIDs have major side effects associated with their use and many individuals do not respond to any medications Neuropathic pain drugs with novel mechanisms of action are being sought as alternatives however the only novel FDA approved drugs which target calcium channels have serious limitations to their general use Neurotensin NT and its fully active fragment NT possess dramatic activity against neuropathic pain when dosed centrally however activity is not seen with systemic administration JT Pharmaceuticals has engineered NT derivatives that exhibit potent analgesic activity when dosed IV and at high concentrations orally The compounds are NT receptor agonists thus operating by a novel mechanism so they are expected not to have the limitations of current analgesics In previous work in this program the NT derivative HPI was selected as the lead for advancement and a wide variety of IND enabling activities were performed This constituted the andquot Phase Iandquot portion of this program In this andquot Direct Phase II SBIRandquot application to advance the program we hypothesize that completion of three Specific Aims will enable HPI to be advanced to clinical trials In Specific Aim the pharmacokinetic pharmacodynamics properties of HPI will be fully characterized The PK PD data are crucial for developing the study designs for preclinical toxicity and safety evaluations in animals prediction of effective human dose and ultimately design of clinical trials In Specific Aim activities necessary for preparation and submission of an IND most notably day toxicity studies in rats and dogs will be completed The goals of Specific Aim will be preparation and submission of the IND to enable initiation of clinical trials Completion o Specific Aim will be performed at JT Pharma in collaboration with the PIandapos s long term collaborator Dr Craig Beeson at the Medical University of South Carolina Specific Aim will be outsourced to a highly reputable contract lab and Specific Aim will be performed at JT Pharma with the aid of consultants as necessary PUBLIC HEALTH RELEVANCE Neuropathic pain management remains a major unmet medical need A derivative of the brain peptide neurotensin having potent analgesic activity has been identified In this investigation preclinical studies supporting submission of an IND for the compound will be completed which will enable its advancement into human clinical trials as a novel analgesic for neuropathic pain