Preclinical development of an intravaginal ring for the sustained release of Pritelivir for the treatment and prophylaxis of Genital Herpes in women

SUMMARY The broadlong term goal of this project is to develop a pritelivir intravaginal ringIVRfor the treatment and pre exposure prophylaxis of genital herpesa common problem that affects more thanmillion AmericansRecurrences are common and may be painfulInfection is life longPritelivir is a promisinghelicase inhibitor that proved superior to existing therapies in Phaseclinical trialsbut whose clinical development as a systemic therapy has been arrested because of toxicityLocal therapy is thereforeof special interestWe have developed a platform technology for the sustained release of antiviralsThis technology led to the FDA approval of a ganciclovir based intraocular implantVitrasertfor the treatment of AIDS related cytomegalovirus retinitisWe have adapted this platform to IVRs and have successfully delivered other antiviral agents at therapeutic levels in preclinical and clinical trialsWe propose to utilize this platform to develop sustained release vaginal ring formulations for pritelivirIn this Phase I proposalwe will formulate pritelivir IVRstest the formulations for in vitro release and perform safety and pharmacokinetic studies in an animal modelSuccessful completion of this work will lead to IND enabling studies in Phase IIand clinical trials in Phase IIB SBIR proposalsThe team of investigators is expert in drug developmentsynthetic chemistrypharmacokineticsand clinical infectious diseaseWe have experience in collaboration with large pharmaceutical companies leading to the approval of novel drug delivery systemsThis project could lead rapidly to the development of an improved treatment for genital herpes NARRATIVE The broadlong term goal of this project is to develop a pritelivir intravaginal ringIVRfor the treatment and pre exposure prophylaxis of genital herpesa common problem that affects more thanmillion AmericansOn averagerecurrences occurtimes a year and infection is life longPritelivir is a promisinghelicase inhibitor that proved superior to existing therapies in Phaseclinical testingbut whose clinical development as a systemic therapy has been arrested because of toxicityLocal therapy is thereforeof special interestWe have developed a platform IVR technology and have successfully delivered other antiviral agents at therapeutic levels in clinical trialsBased on this platformin this Phase I SBIR proposalwe will formulate pritelivir IVRstest the formulations for in vitro releaseand perform safety and pharmacokinetic studies in an animal modelSuccessful completion of this work will lead to IND enabling studies in Phase IIand clinical trials in Phase IIB SBIR proposals