Dignify Therapeutics LLC — Department of Health and Human Services SBIR Phase I: 105

Description

PROJECT SUMMARYABSTRACTSpinal cord injurySCIaffects an estimatedAmericansDamage to nerves in the spinal cord can result in a loss of voluntary control over bladder and bowel function that often produces both incontinence and retention of urine and stools in the same patientThe standard of care for urine retention is bladder catheterization to void urinewhich may produce urinary tract infectionsUTIsand hospitalizationRetention of feces requires manual extraction bowel programswhich are extremely time consumingcan contribute to UTIsand are stigmatizing for patients and caregiversBecause bladder and bowel dysfunction are among the top concerns of people with SCIa convenient and safeon demandrapid onsetshort durationdrug inducedvoiding therapywould be a life changing paradigm shift in treating bladder and bowel dysfunction for those who currently rely on life long multiple daily catheterizations and daily digital bowel programsDignify Therapeutics is developing next generation potent and selective neurokininreceptorNK Ragonists to produceon demandvoiding in people with SCIIn a series of proof of concept studiesthe prototype NK R agonistDTIrapidly induced bladder and bowel voiding in multiple animal modelsA nextgeneration NK R agonistDTIhas been identified that has optimized selectivity andpotentiallyan improved pharmacokineticPKprofile for subcutaneous administrationLike DTIDTIexhibits properties that support a target product profile of rapid onsetshort durationdrug induced voidingIn additiondue to its greater target selectivityDTIpotentially has a greater therapeutic index than DTIDignify is now advancing DTIthrough preclinical development as its lead NK R agonistThis Fast Track CREATE Bio Optimization Track Uapplication is focused on extensive preclinical characterization of DTIfor subsequent IND enabling studies and future support from the CREATE Bio Development programPhase I activities will establish successful synthesisstabilityand bioanalytical measurement of DTIand determine the therapeutic indexTIfor DTIin dogPhase II activities will complete preclinical characterization of DTIand provide additional toxicity and safety assessments prior to the initiation of INDenabling studiesThe proposed project will allow Dignify Therapeutics to develop an optimizedon demandrapid onsetshortdurationdrug inducedvoiding therapyto treat bladder and bowel dysfunction in people with SCIThis therapy would greatly improve quality of life for people with SCIreduce UTIs and associated health risksand decrease overall healthcare costs PROJECT NARRATIVE The ultimate aim of this project is to provide a novel pharmaceutical treatment that will produce convenientefficientand safe on demand voiding of bladder and bowel in people with spinal cord injurySCIMany people with SCI currently rely on life longmultiple daily catheterizations and life longdailydigital bowel programs to void urine and fecesrespectivelyThis grant will enable the advancement of an optimized therapy with reduced risk of side effectsSuccess of our project will restore individual dignityimprove daily quality of life and healthand reduce associated health care costs for individuals who have diminished voluntary bladder and bowel control