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news.Ardana has announced positive preliminary results from a Phase II study of its key compound, the GnRH antagonist Teverelix long acting, which shows that patients may only need to have two maintenance doses per year to treat the symptoms of benign prostatic hyperplasia, a significant potential improvement over current treatments.
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The effects of Teverelix long acting (LA) in this benign prostatic hyperplasia (BPH) study were marked and sustained as well as being both clinically and statistically significant. Following study drug injection, the mean international prostate symptom score (IPSS) was reduced in all three groups (placebo, low dose Teverelix, high dose Teverelix). At two weeks following the second injection, the mean changes were -0.9, -2.4 and -2.0 respectively.
The maximal effect on IPSS was observed in all groups 28 weeks after dosing. The mean reductions were -2.6, -4.5 and -5.4, respectively, where a reduction in the score by greater than four is deemed to be a highly clinically significant improvement. These changes were statistically significant in both the active groups.
BPH is a common benign disease occurring in men over the age of 50 and increases in prevalence with age. BPH is characterized by an enlargement of the prostate gland, which results in urinary flow problems such as hesitancy, weak or interrupted stream, urgency and more frequent urination, especially at night.
Huw Jones, CEO of Ardana, said: “This repeat dose study shows a clinically relevant improvement in symptoms as measured by the IPSS results. It also indicates that BPH sufferers may only need two maintenance doses a year to keep their benign prostate disease under control and improve their symptoms.”