SOUTHAMPTON, England, February 2 /PRNewswire/ -- 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.
Notes to Editors:
About Vantia Therapeutics
Vantia Therapeutics is an emerging pharmaceutical company developing novel, small molecule drugs targeting large, underserved medical markets. Formed in 2008 as a spin-out of Ferring Research Ltd's small molecule RD, it has two clinical phase products, VA106483 for the treatment of nocturia and VA111913 for the treatment of dysmenorrhoea, as well as preclinical and discovery programmes based on protease inhibition with potential in the areas of oncology and inflammation. The company's investors include MVM Life Science Partners, SV Life Sciences and Novo A/S. Vantia Therapeutics Ltd is situated on Southampton Science Park, UK, where it occupies 10,000 sq ft of chemistry and biology facilities. For further information, please go to http://www.vantia.com.
About nocturia
Nocturia (defined as waking to void at night) is a common condition, with prevalence increasing markedly with age. It is often the presenting symptom of benign prostatic hypertrophy (BPH) with at least 70% of BPH patients complaining of nocturia. Whilst some symptoms of BPH are successfully addressed by the standard BPH therapies of alpha blockers and 5-alpha reductase inhibitors, nocturia remains inadequately treated. With estimates putting the number of BPH/nocturia sufferers at 55 million in the seven largest markets world wide, and only 10% of these believed to be receiving any kind of treatment, it is a clear area of unmet medical need estimated to be worth in excess of $500m. The hormone vasopressin is involved in the regulation of the body's water content and as a vasopressin agonist VA106483 has been shown to act as an anti-diuretic.
Contact details: Vantia Therapeutics Andy Crockett, VP Business Development +44(0)238-076-3456, +44(0)787-255-9676 info@vantia.com Citigate Dewe Rogerson Chris Gardner, Mark Swallow, Helena Galilee +44(0)207-638-9571 vantia@citigatedr.co.uk
SOURCE: Vantia Therapeutics
CONTACT: Contact details: Vantia Therapeutics, Andy Crockett, VP BusinessDevelopment +44(0)238-076-3456, +44(0)787-255-9676 info@vantia.com;Citigate Dewe Rogerson, Chris Gardner, Mark Swallow, Helena Galilee+44(0)207-638-9571, vantia@citigatedr.co.uk
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