The phase II proof-of-concept study demonstrated clinically meaningful and statistically significant improvement in the primary endpoint, the international prostate symptom score (IPSS), a seven-item questionnaire that assesses the severity of symptoms of benign prostatic hyperplasia (BPH) and the response to therapy.
The IPSS is the standard scale used for the evaluation of medications that treat the symptoms of BPH. In addition, tadalafil, the active ingredient in Cialis, demonstrated statistically significant improvement relative to placebo on most of the secondary endpoints included in the study.
Patients taking 5mg tadalafil once-a-day, over a period of six weeks, experienced a mean 2.8 point improvement from baseline in the IPSS, compared to patients on placebo with a mean 1.2 point improvement.
After stepping up to 20mg tadalafil and continuing therapy once-a-day for another six weeks, patients experienced a mean 3.8 point improvement from baseline in the IPSS, compared to a mean 1.7 point improvement for patients on placebo.
Both dosages showed clinically meaningful and statistically significant improvement in the primary endpoint. Additional results from the study of 250 patients will be presented at an upcoming medical congress.
“We are delighted with the outcome of this study,” said Paul Clark, Icos chairman, president and CEO. “BPH is a large market with room for new therapies that have a different mechanism of action. Investment in this indication makes a great deal of sense for Lilly Icos, since many physicians treating patients for the current approved use of tadalafil also treat patients with BPH. We look forward to beginning the phase III studies and confirming these results.”