Anelleo, Inc. — Department of Health and Human Services STTR Phase I: NICHD

Description

Infertility is a global health problemand in the USmillion women are treated for infertility every yearThere is a strong need to promote patient friendly methods for progesterone supplementation in assisted reproductive technologyARTIntravaginal rings are well tolerated by womenare efficacious for contraception and hormone replacement therapyhave high patient complianceand are now in development for ARTHoweverdeveloping effective IVRs to deliver progesterone beyonddays is challenging due to limitations of current engineering processesand difficulty in controlling release ratesthus mandating drug specific customized IVR designsOur goal is to address these limitations by revolutionizing the engineering and manufacturing processes for intravaginal ringsusing a state of the artD printing process known as continuous liquid interface productionCLIPUsing the automated CLIP processwe can engineer and manufacture IVRs with surface geometries not achievable with traditional injection molding or extrusionwhich help control drug releaseCLIP enables us to precisely fine tune diffusion and release of drugsto achieve near complete releaseand also control IVR mechanical propertiesImportantlyusing CLIP we can manufacture IVRs that provide sustained release of progesterone to cover the entire ART treatment period in a rapid and cost effective single step processIn this Phase I STTR projectbuilding upon our existing datawe propose to use a state of the art engineering processCLIPto develop a highly effective IVRAnelleO PROto deliver progesterone fordays or longerWe will implement comprehensive rational IVR designusing the highly relevant preclinical sheep model to characterize the safety and pharmacokinetic profiles of AnelleO PROThis multidisciplinary cutting edge approach will develop a unique and highly innovativeD printed CLIP IVRdelivering progesterone in longacting single administration treatment of infertility The benefit of sustained release of progesterone to women who undergo infertility treatment is highly significantLong acting intravaginal formulations providing steady release of progesterone over several weeks can increase compliance to ART regimensproviding a patient friendly modality that could transform the ART landscapeThe overarching goal of this proposal is to develop and evaluate an innovative approach to creating and manufacturing intravaginal rings that can contribute to curbing infertilitya significant global medical need