Strong Ph II data for Plethora's IC/PBS drug

UK-based Plethora Solutions Holdings has reported further encouraging results from a Phase II study of PSD597 in the treatment of interstitial cystitis and painful bladder syndrome (IC/PBS). According to the firm, the full analysis confirms and extends the initial positive outcomes announced last month (Marketletter September 17).

The randomized, 102-patient, double-blind, placebo controlled trial found clear and substantial improvements in Global Response Assessment (GRA), a patient-rated scale of improvement in bladder symptoms which is now an international standard in IC/PBS trials and formed the primary endpoint.

At day eight, 15 patients (30%) in the intent-to-treat population reported moderate or marked improvement after PSD597 treatment compared with only five (10%) randomized to placebo (p=0.012); improvements in the two groups at day 15 were 24% and 12% respectively (p=0.102). Analyzing the response across all GRA categories, the difference with PSD597 treatment at day 15 was highly significantly different from placebo (p=0.005). These positive results were replicated across all secondary endpoints with improvements reported in bladder pain, urinary frequency and urgency, whether assessed as individual symptoms or combined into widely-accepted symptom and problem indices, Plethora noted.