Juniper’s intravaginal ring (IVR) technology is unlike predecessor rings, with powerful capabilities that may revolutionize delivery of single- and multiple-drug therapeutics in women.
This novel IVR was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School.
The drug is extruded in a solid ethylene vinyl acetate (EVA) polymer matrix; no membrane or reservoir is required to contain the drug, or control its release. Through this inherent design, our IVR has the potential to deliver:
Juniper’s IVR technology allows sustained delivery over time—from weeks to months. In addition, our vaginal ring can hold one to two orders of magnitude more drug than transdermal patches, greatly expanding the number and types of drugs that can be delivered, and extends the duration of use from a single dose. In addition, drug delivery using our IVR technology has the potential to provide an improved side effect profile as administered drugs bypass first pass, hepatic metabolism issues and could thus improve patient compliance and convenience of use versus other routes of administration.
In pre-clinical and clinical studies, our IVR technology has demonstrated sustained release of drugs such as progesterone and leuprolide1. We are currently developing three IVR product candidates:
Proof-of-Concept: Successful Delivery of Leuprolide
Its ability to successfully deliver leuprolide was demonstrated in a Phase 1 study published in the Journal of Controlled Release1. This proof-of-concept study explored the ability of this IVR to deliver the nine amino acid peptide leuprolide, a Gonadotropin Releasing Hormone agonist (GnRHa). Leuprolide is sold commercially as an injectable under the brand names Eligard and Lupron for the treatment of precocious puberty, prostate cancer, infertility, fibroids, and endometriosis.
In this clinical trial, six normal healthy female volunteers underwent administration of 18 or 36mg of leuprolide via our novel IVR. Consistent with the biologic activity representative of the leuprolide entering the circulation, serum levels rose within eight hours following insertion and was dose dependent. GnRHa biological activity was validated by secretion of gonadotropins and sex steroids.
These results demonstrate that the non-keratinized vaginal epithelium permits a rapid absorption of a biologically active peptide, and that there is significant potential for a novel transvaginal drug delivery system to deliver peptides and possibly other macromolecules, such as proteins, CRISPR therapeutics, siRNA, mRNA, and monoclonal antibodies, therapeutically in women.