Inhibikase Therapeutics, Inc. — Department of Health and Human Services SBIR Phase II: 399

Description

Inhibikase Therapeutics is a clinical stagebio pharmaceutical company that has developed a novel prodrug formulation for the popular anticancer agent GleevecGleevectreatment is commonly accompanied by significantburdensome gastrointestinal side effectsfatigue and myalgias that erode therapy success due to poor patient complianceInhibikaseandapos s prodrug of GleevecIkTProProcompletely blunts these side effects in comparative toxicology testing in non human primatesAnalysis of the relative anti tumor activity ofPro in Kand in human patient derived liquid tumor models has revealed that the prodrug more efficiently delivers imatinib to the target tissueenabling up tooral dose reduction to achieve the same total drug exposure in the body and the same tumor controlThis unexpected finding portends an even greater safety benefit for patients because the Adeverse EventAEfrequency and severity varies linearly with oral dose for GleevecIf the observed oral dose reduction to achieve the same Area Under the CurveAUCis realized in human patientsthen significantly less imatinib will be administered to achieve the same therapeutic effect and will result in a substantial reduction in AE frequency and severityThis suggests that a Gleevecprodrug could substantially benefit patients undergoing treatment for stable phase Chronic Myelogenous LeukemiaGiven that Gleevecis now genericthere is little commercial motivation to introduce innovations into the treatment landscape for this devastating diseasewhich now afflicts more thanpatients in the U SThe prodrug could be approved inmonths from initiation of the single clinical trial agreed to between the FDA and Inhibikase Therapeutics under thebregulationThusa simple alteration to a well established generic anti cancer agent could bring urgently needed relief from adherence related side effects to these critically ill patients in a short period of timeCommercial success is likely given that the generic Gleevecmarket has experienced gross sales andgt$billion USD in the U Smarket Inhibikase Therapeutics is a clinical stage bio pharmaceutical company developing a novel strategy for treating cancer using new Gleevec like agents with substantially improved safety and efficacyUp topatients annually could benefit from these agents