LEXINGTON,MA– TARIS, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced positive preliminary safety and efficacy data from its clinical study of TAR-302 for the treatment of patients with idiopathic overactive bladder (OAB) refractory to oral therapy.
Subjects in the Phase 1b study received a single TAR-302 system, which provides continuous local dosing of the approved antimuscarinic agent trospium into the bladder. Subjects who were experiencing an average of more than five daily urge incontinence episodes demonstrated a reduction in mean daily episodes of 75% following dosing for 42 days (p=0.0049). Based on the unmet need in this disease state and the efficacy demonstrated in this study on established endpoints, TARIS plans to rapidly advance this program into later stage trials.
“The results of this study suggest TAR-302 may come to represent an innovative new approach to treating overactive bladder,” said Michael J. Kennelly, M.D., FACS, Professor of Urology at Carolinas Medical Center, Medical Director of the Charlotte Continence Center and Women’s Center of Pelvic Heath, and Principal Investigator of the TAR-302 clinical studies. “There is a substantial need for alternative options in the management of OAB when patients fail oral therapies. The compelling efficacy observed to date with TAR-302, in the absence of side-effects, represents a potentially significant advance in the development of improved therapies for these patients.”
In the multi-center study, TAR-302 was deployed into the bladder on day zero and continuously released drug for 42 days. Preliminary data in 11 subjects with a moderate to severe burden of disease who had failed multiple oral agents demonstrated:
- A reduction in mean daily incontinence episodes of 75%
- Substantial, clinically meaningful reductions in patient-reported symptom bother, and commensurate increases in health-related quality of life measures
- Negligible systemic drug exposure throughout the study
- TAR-302 was well tolerated
“TAR-302 is a validation of our commitment to develop transformational therapies to treat people with serious urological disorders,” said Purnanand Sarma,President & CEO, TARIS. “Current approaches to treating these diseases, including overactive bladder, are inadequate and often result in poor quality of life. These study data continue to support TARIS’ ability to access disease targets through continuous local therapy. By unlocking novel epithelial biology at the site of the disease, we may be able to fundamentally redefine the management of OAB, a debilitating condition for millions of patients.”
TARIS plans to present full results of this study at an upcoming scientific meeting.