Vantia Therapeutics initiates Phase IIb trial of VA106483 for nocturia

Feb 2 2010

Vantia Therapeutics, an emerging pharmaceutical company developing novel, small molecule drugs targeting large, underserved medical markets, today announces it has begun its planned Phase IIb trial of its lead development compound VA106483 for nocturia. The study is a randomised, double-blind, placebo-controlled study and is expected to recruit approximately 120 male patients at 20 centres in the US. The study will primarily assess number of nocturnal voids per night. Secondary endpoints include quality of life and sleep duration measures.

Nocturia (defined as waking to urinate at night thereby significantly disturbing sleep) is a common condition, with prevalence increasing markedly with age. It is often the presenting symptom in men with benign prostatic hypertrophy (BPH) and affects at least 70% of BPH patients. There are currently significant limitations in the treatment for nocturia and it represents a potential market estimated at more than US$1 billion.

In June last year, Vantia Therapeutics announced positive results from its Phase IIa trial of VA106483. The trial showed that oral VA106483 produced a predictable antidiuretic effect in elderly subjects, as determined by increased osmolality and decreased urine output. The study also showed that VA106483 was generally well tolerated in an elderly patient population.

VA106483 is a novel small molecule drug candidate that exerts its effect directly in the kidney by binding to vasopressin (V2) receptors, which regulate water excretion. It was discovered by scientists at Vantia Therapeutics from its extensive drug candidate library.

Dr Hilary McElwaine-Johnn, CMO of Vantia Therapeutics, said "Nocturia is a common condition, the prevalence of which increases markedly in older people. It is disruptive to sleep and can have a significant impact on the quality of life of patients. Our research suggests that only a very small percentage of patients with this symptom receive any kind of treatment. We are very pleased therefore to be starting this larger clinical study with VA106483 based on the encouraging results seen in earlier clinical studies."