Progressing the Pre-clinical development of P8 for Alzheimer's Disease

Progressing the Preclinical Development of Pfor Alzheimer s disease This SBIR competitive Phase IIB renewal application is to continue with the preclinical development of Cenna s lead peptide drug candidatePto treat Alzheimer s diseaseADThere is currently no cure for the diseaseThe pathological hallmarks of the disease include the formation and accumulation in the brain of Awidely recognized to be the major neurotoxic agent in ADEarlier therapeutic attempts at lowering total Aproduction were unsatisfactory as they directly targeted the catalytic activities oforsecretaseenzymes known to hydrolyze other substrates besides APPmany with critical cellular functionsNew therapeutic approaches that can inhibit total Aproduction without targeting the activities of theor thesecretase are therefore of great interestWe have a novel technology that does not target the secretaseswhich has yielded a potential peptide drug candidatePwith the ability to inhibit the production of Ain vitro and in a transgenic mouse model of ADPis being developed as a new peptide drug for the treatment of ADIn this application we propose to build upon the substantial progress made in the last two years of Phase II funding and to continue with the preclinical development of PSpecificallywe propose to further develop the formulation of Pas a subcutaneous injectable drug and carry out investigative non GLP studies that will provide a toxicological and toxicokinetic assessment of Pin formulation in order to facilitate its movement into GLP regulatory toxicological testingwhich provides a full assessment of the safety profileEfficacy of Pin formulation will be assessed in APP transgenic miceLarger quantities of non GLPGLP and GMP grades of Pwill also be synthesized and characterized for the current proposed work and future IND enabling toxicology and Phasestudies