SCARLESS LABORATORIES INC — Department of Health and Human Services SBIR Phase II: NIDCR

Description

PROJECT SUMMARY ABSTRACT Normal skin scarring and pathological hypertrophic scarringHSare common complications of surgeryHS is more prevalent in non Caucasian patientsup tomay require multiple surgical revisionsand can cause severe functionalaestheticand psychological difficultiesHS is a common postsurgical outcome for cleft lip and palateCLPthe most common craniofacial congenital anomaly present at birthOur goal is to develop our fibromodulinFMODbased peptideFCto promote healing and reduce scar formation in mechanically approximated dermisOur proposed broad indication in cutaneous scar reduction will address an unmet need in a large population of patientsthus making it very commercially attractive to potential partners and investorsThisin turn will enable us to meet the needs of patients in less commercially viable areas such as CLP which reflects the mission of the National Institute of Craniofacial and Dental Research InstituteNIDCRThis PARCommercialization Readiness PilotCRPSBproposal directly continues the FastTrack SBIR Phase II award RDE`Anti scar peptide for cleft repairandaposand is intended to accelerate the Investigational New DrugINDsubmission for first in human FCtrialsBased on FDA guidanceScarless LaboratoriesSLhas designed the phaseclinical study and plans to submit the IND application and begin phasestudies before the end ofyearTo expedite and derisk critical technicalregulatory clinicaland business milestone activities that could impact or delay FCcommercializationwe proposed the following CRP SBAIMsAIMwill support CMC technical development and minimize technical risks by ensuring a robust ensuring a robust process development optimization program for FCDS production and an analytical development and validation plan for FCDPAIMwill expedite clinical development and minimize regulatory risks by incorporating quantifiable drug development tools to ensure efficient development with optimal clinical study design and develop clinical methods to assess safetyefficacy and related pharmacokinetics in our clinical program to meet FDA requirementsAIMwill support the conduct of extended toxicology studies including animal pharmacokinetics to support longer dosing of patients in clinical studiesa greater breadth of indications and populations at risk with unmet needsand AIMis intended to fully integrate SLandapos s intellectual propertymarket focusand business strategies to maximize valuationIf fundedwe have also secured commitments for $M non SBIR Phase III `matchingandaposfunds from investors to finish phaseclinical studiesOur long term goal is to improve outcomes for all patients with skin wounds due to surgeryburnsor other trauma PUBLIC HEALTH RELEVANCE Excessive scar formation is a common complication of surgeryIt is a significantly greater problem in minorities with darker skinThe esthetic and functional concerns can be severe in children with cleft lip and palateCLPCLP is the most common birth defect of the headoccurring at a rate ofperlive births in the USCleft lips are typically repaired during infancy and may result in excessive scarringThis scarring often tethers or retards the growth of bone and soft tissues in the upper jaw lip and leads to the need for extensive surgeries to correct both the bone and soft tissue deformitiesThis project seeks to develop a safe and effectivenovel peptide based treatment to reduce scarring and improve the quality of life of patients including those with cleft lip and palate suffering from excessive scar formationMost importantlythe peptide has promising application to all scars due to surgery or other trauma