Biofusion plc (AIM: BFN), the university IP commercialisation company that turns world class research into business, is today pleased to note that Phoqus Group plc (“Phoqus”), the oral drug delivery and development company that is working in collaboration with Biofusion’s subsidiary company Diurnal Limited (“Diurnal”), has today announced the successful completion of study #003, the third phase I clinical study of Chronocort™ in healthy human volunteers, confirming the safety and tolerability of Chronocort™.
Chronocort™ is a modified release tablet containing hydrocortisone that is under development by Phoqus for both adrenal insufficiency and congenital adrenal hyperplasia.
The key objectives for this study were to evaluate formally the dose proportionality for Chronocort™ and the effect of food on the pharmacokinetic ("PK") performance of Chronocort™, in accordance with regulatory guidance. The study was conducted in the UK, in 28 healthy volunteers in a three-way cross-over design, in compliance with Good Clinical Practice. The results show that Chronocort™ provides an excellent PK performance and the PK data are reproducible and consistent with those generated in study #002. The data show that Chronocort™ has a low susceptibility to the effects of food, with only the expected slight increase in the time taken for maximal absorption and the extent of exposure for hydrocortisone. There was no evidence of rapid release or "dose dumping", emphasising Chronocort's robust in vivo performance. Data have now been collected over three phase I studies, involving a total of 58 healthy subjects, demonstrating a reproducible, dose-dependent PK profile.
The successful completion of study #003 marks a substantial milestone for Phoqus with the formal completion of evaluation of Chronocort™ in healthy subjects. The study underpins the progression to patient studies scheduled to start during August 2007.
Chronocort™ is under development by Phoqus for both adrenal insufficiency ("AI"), the failure of the adrenal glands to produce sufficient steroid hormones, and congenital adrenal hyperplasia ("CAH"), a serious genetic disorder caused by the deficiency of an enzyme responsible for cortisol production. Both conditions require patients to take life-long corticosteroid hormone replacement therapy. However, current therapy does not provide steroid in a natural physiological manner and as a result often only poorly controls disease symptoms and can lead to the unwanted side effects of steroid therapy. Chronocort™ is designed to provide a new form of corticosteroid hormone replacement therapy by releasing hydrocortisone in a manner that will enable doctors to achieve a daily cycle (circadian rhythm) of cortisol levels in patients that closely matches that of the normal population. This should improve disease symptom control and may also increase the accuracy of the disease treatment and monitoring regimen, potentially reducing the incidence of over or under exposure to steroids.
Chronocort™ has already successfully completed two other Phase I clinical studies which demonstrated that Chronocort™ is capable of achieving the target pharmacokinetic profile. Planning is underway for the remaining clinical development programme which includes pivotal Phase III pre-registration studies in both CAH and in AI.
Later this month, Phoqus is planning to undertake a short Phase II PK/PD study in patients with CAH at the US National Institute of Health ("NIH") as a prelude to the pivotal Phase III study in CAH, expected to commence during the first quarter of 2008. Phoqus expects the CAH Phase III study to complete at the end of 2008, with filing for regulatory approval in the first quarter of 2009. The Company anticipates that Chronocort™ will be available for launch in the CAH indication during the fourth quarter of 2009, assuming an accelerated review period of six months due to the unmet medical need in these patients.
The Phase III study for patients with AI is also expected to commence during the first quarter of 2008 and to complete during the first quarter of 2009, with filing during the second quarter of 2009. EMEA feedback and the pre-IND meeting with the FDA for the AI pivotal development programme are expected during August / September this year.
Phoqus' CEO, Dr. Richard Mason, commented: "Chronocort has successfully concluded its studies in healthy volunteers and we now look forward to commencing clinical trials in patients in order to demonstrate the clinical benefit of Chronocort over the current standard of care in both congenital adrenal hyperplasia and adrenal insufficiency."