Biofusion plc (“Biofusion” or the “Company”) (AIM:BFN), announces that its subsidiary Diurnal Limited (“Diurnal”), in collaboration with Phoqus Group plc (“Phoqus), has begun its Phase I clinical trials programme on Chronocort – the first Circadian Endocrine treatment for adrenal insufficiency.
Diurnal has a collaboration programme with Phoqus 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 native steroid hormone, creating an unmet need in the worldwide market valued at in excess of £75 million per year. Biofusion believes that a sustained-release tablet using Diurnal’s technologies would address this need effectively and provide a much needed treatment.
The initial Phase I trial, which will involve healthy volunteers dosed with the modified release hydrocortisone tablet formulation, is expected to be completed in early 2006. The objective is to evaluate the correlation between in-vitro hydrocortisone releases with the in-vivo blood levels observed following oral administration.
Under the terms of the agreement, Phoqus is supplying Diurnal with the tablets for the drug, which has already obtained orphan medicinal product designation in the EU.
David Baynes, Chief Executive Officer of Biofusion, said:
“We are pleased to see Chronocort entering Phase 1 clinical trials as planned. We value Diurrnal’s partnership with Phoqus, and look forward to progressing this product to the market with them.”
Andy Jones, Chief Executive Officer of Phoqus, commented:
“We are delighted that Chronocort has entered Phase I. Our technology allows the modified release of the drug into the patient which we believe is crucial for effective treatment, and should greatly benefit patients with simplified dosing and reduced side effects. ”