TheraVida to conduct more studies of Tolenix after reporting positive Phase II data
This article was originally published in Scrip
TheraVida said it intends to conduct additional international clinical trials of its lead product candidate, Tolenix (THVD-201), for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI) having reported positive Phase II data for the drug.
The Mountain View, California-based firm believes that the Phase II trial results "clearly demonstrate that Tolenix has the ability to provide patients with bladder control, while reducing dry mouth side-effects typically associated with OAB medications such as Detrol [Pfizer's tolterodine]".
Tolenix is a twice-daily (BID) proprietary combination of tolterodine (a muscarinic antagonist used to treat OAB) and pilocarpine (a muscarinic agonist approved to treat dry mouth).
TheraVida, a clinical-stage biopharmaceutical company focusing on novel combination drug products, noted that dry mouth side-effects are a primary reason for poor compliance in this patient population. "We believe there is a significant opportunity for a new OAB treatment option for currently diagnosed patients and the aging population. Tolenix has the potential to improve the overall tolerability, compliance, and satisfaction for patients with OAB and UUI," it stated.
Phase II study details
The randomised, double-blinded, multiple-crossover Phase II trial evaluated the safety and efficacy of Tolenix in reducing the frequency of micturition (urination) and incontinence episodes per day, as compared to both placebo control and active control Detrol. Common side-effects of muscarinic antagonist therapies, such as dry mouth, were also assessed in the 138 patients enrolled in this international trial conducted in South Korea, Australia, and New Zealand.
Patients receiving Tolenix (2mg tolterodine plus 9mg pilocarpine, administered BID) 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 (2mg tolterodine, administered BID), TheraVida said.
It added that those 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.
The company additionally highlighted that the study demonstrated a favourable therapeutic index, which could permit higher dosing of Tolenix in some patients, adding that a higher dose of Tolenix (3mg tolterodine plus 13.5mg pilocarpine, administered BID) was studied in a 12-week open-label extension period, in a subset of patients in this trial. In this extension period, the higher dose of Tolenix exhibited the potential to provide greater bladder control, while minimising dry mouth side-effects, it claimed.
TheraVida added that it intends to present detailed efficacy and tolerability results from the study at an upcoming scientific meeting.