Biofusion plc (“Biofusion” or the “Company”) (AIM:BFN) announces that its subsidiary Diurnal Limited (“Diurnal”), in collaboration with Phoqus Group plc (“Phoqus”) has successfully completed the Phase I clinical trials programme on Chronocort - the first Circadian endocrine treatment for adrenal insufficiency.
In line with the collaboration’s current strategy, Phoqus plans to license the product, later in 2006, to a marketing partner to complete the development and launch the product. Chronocort already has orphan medicinal product designation in the EU and Phoqus directors believe a product could be launched on the market in the period 2008-2009.
Results from the study showed that Chronocort released drug and generated blood levels of hydrocortisone which closely mirrored natural levels of hormone seen in healthy individuals. This indicates that Chronocort may be a valuable therapeutic tool for the treatment of adrenal insufficiency where cortisol levels are abnormally low. Additionally, Chronocort showed a correlation between in-vitro hydrocortisone release and in-vivo blood levels observed in the subjects following oral administration. The study also showed that Chronocort was well tolerated, with no treatment-related adverse events being reported.
The Phase I trial involved healthy volunteers who had their natural cortisol hormone production suppressed and were then dosed with Chronocort. The objectives of the study were firstly to evaluate the ability of Chronocort to release hydrocortisone in the blood in a way that mimics natural circadian hormone release and secondly to demonstrate a correlation between in-vitro hydrocortisone release and in-vivo blood levels observed following oral administration.
The Diurnal collaboration with Phoqus was set up to develop Chronocort, a once-daily modified release hydrocortisone tablet for the treatment of adrenal insufficiency, a condition which causes Addison’s disease, hypopituitarism and congenital adrenal hyperplasia. Current steroid therapies for these conditions do not mimic the natural circadian rhythm of the endogenous steroid hormone, creating an unmet need in the annual worldwide market worth in excess of £75 million. Phoqus believes that the Chronocort tablet would address this need effectively and provide a much needed treatment.
Under the terms of the Diurnal agreement, Phoqus is supplying the tablets for the drug, which has already obtained orphan medicinal product designation in the EU.
David Baynes, CEO of Biofusion, said:
“This is excellent news for Diurnal. The company continues to meet its milestones for the development of this product and we look forward to working with Diurnal and Phoqus in progressing this product to the market as quickly as possible.”
Andy Jones, Chief Executive Officer of Phoqus, commented:
“We are delighted that Chronocort has successfully completed this Phase I trial. The study has clearly demonstrated that our technology allows the modified release of the drug into the patient in a way that mimics natural hormone release. These results will form the basis of the next phase of development and allow us to seek a marketing partner for the product.”
Professor Richard Ross, Managing Director of Diurnal, said:
“I am delighted with the results which confirm our belief that a delayed and sustained formulation of hydrocortisone can mimic the natural levels of this steroid in man. As a clinician, I find it very satisfying that patients who suffer from a lack of cortisol could have the potential to be treated more effectively for this rare but serious condition.”