Jan 17 · Estimated primary completion date of PIII Infacort004 (NCT02733367) is Aug 17 .
Oct 16 · Diurnal announce pivotal PIII trial (Infacort003) met its primary endpoint, demonstrating a statistically significant (p<0.0001) increase in cortisol values following administration of Infacort compared to pre-dose values. The median 60‑minute cortisol level achieved after Infacort treatment was 535 nmol/L, which is comparable to the mean peak morning cortisol of healthy children .
Oct 15 · Diurnal initiates the long-term follow-up PIII Infacort004 trial to assess safety and biochemical disease control of hydrocortisone granules in neonates, infants and children with CAH and adrenal insufficiency previously enrolled in the Infacort003 study (EudraCT2015-000458-40). The open-label trial is recruiting 24 patients in Germany .
Feb 15 · Diurnal initiates the open-label PIII Infacort003 study to evaluate safety, efficacy, pharmacokinetics and pharmacodynamics of Infacort® in congenital adrenal hyperplasia patients, aged 0-11 years (P01-2012; EudraCT2014-002265-30). Serum cortisol concentration after 240 minutes of administration will be evaluated as primary endpoint for the study. The study intends to enrol approximately 24 patients in Germany .
Dec 13 · Diurnal announces Infacort001 trial met its primary objective of demonstrating bioequivalence of Infacort® 10mg and marketed hydrocortisone tablets. The agent was safe, well-tolerated and was shown to be of neutral taste .
Nov 13 · A second PI trial of the paediatric hydrocortisone formulation was completed in the UK (Infacort002; NCT01960530). The trial investigated pharmacokinetics and oral bioavailability of immediate-release hydrocortisone tablets, and the relationship between drug concentrations and metabolic effect, in 14 healthy adult male volunteers .
Sep 13 · Diurnal completes a first-in-human PI trial in the UK, which compared pharmacokinetics of its immediate-release hydrocortisone formulation, Infacort® 10mg, and a marketed immediate-release formulation 10mg, in 16 healthy adult male volunteers (Infacort001; P031-2013; EudraCT 2013-000260-28). The randomised, crossover open-label trial also evaluated the dose-proportionality of Infacort® over the dose range 0.5, 2, 5 and 10mg. This trial is part of the Paediatric Investigation Plan .