TheraVida, Inc., a clinical-stage biopharmaceutical company, develops and commercializes pharmaceutical products in the fields of urology and central nervous system disorders. The company focuses on programs for the improved treatment of overactive bladder (OAB) and urge urinary incontinence. Its product Tolenix (THVD-201) is a combination of tolterodine, a muscarinic antagonist used to treat OAB; and pilocarpine, a muscarinic agonist to treat dry mouth (xerostomia). The company’s Tolenix drug platform is applied to anti-muscarinic therapies, such as ditropan (oxybutynin) or detrol (tolterodine) to eliminate the dry mouth side effect associated with these agents. TheraVida, Inc. was founded ...
177 Bovet Road
San Mateo, CA 94402
Founded in 2005
TheraVida, Inc. and SK Chemicals Announce License Agreement for the Development and Commercialization of THVD-201 and THVD-202 for Overactive Bladder in South Korea
Apr 2 13
TheraVida, Inc. and SK Chemicals Co. Ltd. announced the execution of a license agreement for two of TheraVida's proprietary combination drug product candidates, THVD-201 and THVD-202. The agreement grants SK Chemicals exclusive rights to develop and commercialize THVD-201 and THVD-202 in South Korea for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI). THVD-201 is a proprietary twice-daily (BID) formulation of tolterodine and pilocarpine that is designed to treat OAB and UUI with reduced dry mouth side effects frequently associated with currently available treatments. THVD-201 has completed Phase 1 and Phase 2 development in international clinical trials. THVD-202 is a proprietary once-daily (QD) formulation of tolterodine and pilocarpine that is completing pre-clinical development. According to the agreement, SK Chemicals is responsible for costs associated with the manufacturing, Phase 3 clinical development, regulatory approval, and commercialization of THVD-201 in South Korea. SK Chemicals is also responsible for clinical development, approval, and commercialization of follow-on product THVD-202 in the territory. In return for the exclusive license to THVD-201 and THVD-202 in South Korea, TheraVida shall receive milestone payments and a royalty on net sales of the products by SK Chemicals.
TheraVida, Inc. Announces Phase II Results for Tolenix in Patients with Overactive Bladder and Urge Urinary Incontinence
Jan 3 13
TheraVida, Inc. announced positive results from a Phase 2 clinical trial of its lead product candidate Tolenix for the treatment of overactive bladder and urge urinary incontinence. Tolenix is a twice-daily proprietary combination of tolterodine, a muscarinic antagonist used to treat OAB, and pilocarpine, a muscarinic agonist approved to treat dry mouth. The objectives of the randomized, double-blinded, multiple-crossover Phase 2 trial were to assess the safety and efficacy of Tolenix in reducing the frequency of micturition and incontinence episodes per day, as compared to both placebo control and active control Detrol. In addition, common side effects of muscarinic antagonist therapies, such as dry mouth, were carefully assessed in the 138 patients enrolled in the trial. This international Phase 2 clinical trial was conducted in South Korea, Australia, and New Zealand. Patients receiving Tolenix experienced statistically significant improvements in their OAB and UUI symptoms over placebo control, as well as efficacy similar in magnitude to the maximum dose of active control Detrol. Patients receiving Tolenix exhibited no significant safety issues, and demonstrated statistically significant and clinically meaningful improvements in their saliva production and dry mouth side effects, as compared to active control Detrol . This Phase 2 study also demonstrated a favorable therapeutic index, which may enable higher dosing of Tolenix in some patients. A higher dose of Tolenix was studied in a 12-week open-label extension period, in a subset of patients in this Phase 2 trial. In this extension period, the higher dose of Tolenix exhibited the potential to provide greater bladder control, while minimizing dry mouth side effects. TheraVida intends to conduct additional international clinical trials of Tolenix in patients with OAB and UUI.