Advicenne reports Phase III data for renal tubular acidosis candidate

In September, Advicenne Pharma S.A. (Nimes, France) reported data from a Phase III trial showing that among 30 evaluable patients with distal renal tubular acidosis, twice-daily oral ADV7103 was superior to standard of care (SOC) alone (p<0.0047), as well as non-inferior to SOC, at correcting metabolic acidosis, a secondary endpoint. The company said normal blood bicarbonate levels were attained by "most" patients and kalemia was normal in both treatment groups. Data were presented at the European Society of Paediatric Nephrology meeting in Glasgow.

The open-label, European trial evaluated mean doses of 1.7, 2.3, 3.8 and 6.1 mEq/kg ADV7103 per day. The trial's primary endpoint is safety. Other secondary endpoints include hypocitraturia, hypercalciuria, crystalluria and compliance...