MANY PHARMACEUTICAL TECHNOLOGIES ARE SOLUTIONS IN SEARCH OF A NEED. AT TARIS®, THE NEED INSPIRED OUR SOLUTION.
Several complex parameters (e.g. ease of use, tolerability, avoidance of expulsion, drug payload) need to be carefully balanced in designing a system that is capable of continuously delivering drugs to the bladder. The TARIS® system achieves these objectives using a brilliantly simple and elegant design:
- Deployment and retrieval using minimally invasive in-office procedures (catheter, cystoscopy)
- Small, flexible footprint, designed to move freely in the bladder
- The ability to change from to a linear form for insertion and return to “pretzel” shape once in the bladder
- Contains a solid drug core
The TARIS® system is a controlled release dosage form for use in the bladder. It is composed of materials with a long history of clinical use in the bladder. The current design uses a dual-lumen silicone tube, which contains a solid drug core in one lumen and a superelastic wireform in the other to impart shape. The system uses passive delivery principles to continuously release drug in the bladder over weeks to months. This technology allows drug release to be tailored to match the needs of specific treatment regimen.
The TARIS® approach begins with a deep evaluation of the unmet needs in difficult-to-treat urologic diseases. Utilizing drugs with known pharmacology and our expertise in bladder biology and bladder pharmacokinetics, we are able to rationally design products aimed at addressing these unmet needs. We believe that our technology has the potential to yield products with significantly improved efficacy, minimal systemic side effects, and guaranteed compliance.
We leverage the bladder’s natural design and function to redefine how bladder diseases should be treated:
- The bladder lining contains a rich supply of drug targets for a variety of bladder diseases, which can be effectively targeted using our approach.
- The bladder is designed as a storage organ, and is generally impermeable to chemicals in the urine. This feature also limits systemic exposure of drugs after local delivery, thus potentially minimizing side effects compared to systemic administration.
TARIS® is pioneering the understanding of bladder biopharmaceutics (absorption, distribution, metabolism, excretion and toxicology) in the context of continuous local delivery. Much of the available knowledge about the behavior of molecules delivered systemically is not relevant to the bladder. TARIS® has established multiple proprietary tools and models to rapidly screen and select drug candidates. In addition, we have the ability to translate this understanding into development programs, which can be rapidly advanced into the clinic.
The safety and tolerability of our device was initially demonstrated in a normal healthy volunteer study1. The TARIS® system has subsequently been administered to over 140 subjects in the clinic, including patients with diseased bladders. Our current programs use molecules with known pharmacology relevant to the disease indication. Combining known agents with a better delivery system is expected to yield products with substantially better efficacy and reduced side effects.