LEXINGTON, Mass., May 1, 2019 /PRNewswire/ -- TARIS Bio™, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced today the initiation of a new clinical investigation of TAR-302 for the treatment of overactive bladder (OAB). As a new follow-on arm of the company's previously concluded Phase 1b trial, the study is designed to investigate the safety, tolerability, and preliminary efficacy of a single 12-week dose of the system, doubling the previous treatment experience and representing a duration that better meets the real-world needs of patients with this serious and chronic disease.
In the previous trial arm, 11 patient participants who had failed multiple oral agents and were experiencing an average of more than five urge incontinence episodes daily, received a single dose of TAR-302 in their bladders for 42 days. The continuous targeted delivery of trospium to the bladder provided by TAR-302 was safe, well-tolerated, and resulted in a mean reduction in daily incontinence episodes of 75% (p=0.0049). Patient participants also enjoyed substantial improvements in health-related quality of life measures.
"The first clinical investigation of TAR-302 offered striking proof-of-concept evidence of this drug's ability to improve OAB symptoms. This more robust study with an extended duration of treatment will inform the design of our Phase 2 program," said Christopher J. Cutie, M.D., Chief Medical Officer of TARIS Bio. "By directly engaging the epithelial biology of the bladder, we may be able to restore this organ's sensory system and potentially offer a disease-modifying therapy to address the needs of the 750,000 patients in the U.S. with OAB who fail oral medications, often due to systemic side effects."
This open label study will enroll and dose approximately 30 patient participants with OAB across multiple sites in the U.S. To be eligible to participate in the study, patients must suffer from at least four incontinence events over a three day period; these symptoms must be refractory to oral antimuscarinics, or patients must experience limiting side effects with these medications. Study subjects will have a single dose of TAR-302 administered intravesically via catheter at the start of the study. Subjects receiving TAR-302 will be evaluated for safety, tolerability, and preliminary efficacy, as well as subjects' perceived symptom bother and health-related quality of life. (NCT03109379)
"This new study arm builds on our early TAR-302 data, seeking to translate this promise into direct evidence of product value. Data supporting the benefit at 12 weeks would position TAR-302 to potentially offer continuous, highly efficacious, year-round symptom control for OAB patients with convenient dosing of just four times per year," said Tony Kingsley, President and CEO of TARIS Bio.
About Overactive Bladder
One out of every six American adults suffers from symptoms of overactive bladder (OAB).i OAB is characterized by urinary urgency, frequency and incontinence; these symptoms have a profound negative impact on patients' daily activities and quality of life. OAB can result from an underlying neurologic injury (neurogenic detrusor overactivity, or NDO) or from unclear etiology (idiopathic overactive bladder, or iOAB). Antimuscarinic agents are available in oral and transdermal dosage forms, but their utility is limited by systemic side effects.
TAR-302 is TARIS' lead investigational program in overactive bladder, and is designed to continuously release the antimuscarinic agent trospium in the bladder for multiple months, at local concentrations several times higher than achievable with oral treatment. TARIS believes that TAR-302 has the potential to improve efficacy, reduce side-effects, and unlock powerful new pharmacology compared with oral therapy. TARIS is evaluating TAR-302 to address unmet needs in both idiopathic and neurogenic OAB.
About TARIS Bio™
TARIS Bio is developing transformational therapies to treat people with debilitating urological disorders. The company is unlocking novel epithelial biology through continuous disease engagement with its unique platform. TARIS' lead programs in bladder cancer and overactive bladder position the company to improve patient health and redefine urologic care. www.tarisbio.com
i Stewart WF, World J Urol (2003) May;20(6):327-36
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