Elocalcitol falls short in prostatitis trial but has potential in BPH/OAB

Italian drugmaker BioXell SpA says that a proof-of-concept trial of elocalcitol in patients with non-bacterial chronic prostatitis has failed to demonstrate its superiority to placebo in reducing pelvic pain, the study's primary endpoint. The firm reported that, in contrast, the drug produced promising results in several of the trial's secondary endpoints, particularly in terms of its anti-inflammatory effect on the lower urinary tract.

While comparable to placebo in reducing Chronic Pelvic Pain Score, the drug did bring about a clinically-significant reduction in the level of interleukin-8 in the semen, a marker for inflammation in the lower urinary tract. In addition, 55% of those treated with the product saw their micturition frequency reduced to less than 110 times per day, compared with only 14% of the placebo group who achieved such a reduction.

Franceso Sinigaglia, BioXell's chief executive, said that elocalcitol will no longer be developed for pain-related indications, but would, based on the promising trial data, continue to be assessed as a treatment for benign prostatic hyperplasia, overactive bladder and other LUT symptoms.