Preclinical development of an intravaginal ring for the sustained release of octreotide for the treatment of acromegaly

PROJECT SUMMARY The broad long term goal of this research program is to develop a novel treatment for women with acromegaly a sustained release intravaginal ring IVR formulation for octreotide Intramuscular sustained release octreotide has been extensively studied and validated in the treatment of acromegaly IVR delivery is a novel and theoretically feasible platform that can deliver peptides at clinically relevant levels We believe that the potential of sustained release IVR formulation is very underappreciated More women use rings for contraception than implants or patches American women prefer rings to birth control pills We have formulated intravaginal rings delivering a wide variety of small molecules peptides and proteins using our pod technology In preliminary work we have formulated a pilot IVR which releases octreotide in vitro over a day period For this Phase SBIR application we intend to further develop this ring to release an unprecedented days sustained release of octreotide in sheep an FDA preferred pre clinical animal model for intravaginal delivery The specific aims of this Phase proposal are to manufacture pre clinical batches of octreotide IVRs and to conduct a dose escalation preclinical pharmacokinetics and toxicity study The hypothesis of this study this project is that we can demonstrate clinically relevant plasma octreotide levels over a sustained period in the in vivo model We propose a straightforward development plan to test this hypothesis that has readily measurable milestones This proposal builds on Auritec Pharmaceuticalsandapos successful technology platform and has a high probability of success Subsequent clinical trials will establish the value of these IVRs as treatments for women with acromegaly PROJECT NARRATIVE The broad long term goal of this research program is to develop a novel treatment for women with acromegaly a sustained release intravaginal ring IVR formulation for octreotide In preliminary work we have formulated a pilot ring which releases octreotide over a day period The specific aims of this Phase proposal are to manufacture pre clinical batches of octreotide IVRs and to conduct preclinical pharmacokinetics and toxicity studies Subsequent clinical trials will establish the value of these rings as treatments for women with acromegaly