Oral drug development company, Phoqus, has announced that it has completed Phase I of its clinical study on Chronocort, the first circadian endocrine treatment for adrenal insufficiency that current steroid therapies for this condition do not mimic.
The successful completion of this stage of clinical trials brings the drug a step closer to an eventual launch date that should see the company make significant impact in the annual worldwide market worth in excess of £75 million, (€63 million).
Phoqus now 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 with a 2008-2009 launch date expected.
Phoqus has a collaboration with Diurnal 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.
The Phase I trial involved 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.
Results from the study showed that Chronocort released drug and generated blood levels of hydrocortisone, which 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.
"These results confirm our belief that a delayed and sustained formulation of hydrocortisone can mimic the natural levels of this steroid in man," said Professor Richard Ross, managing director of Diurnal.
"As a clinician, I find it 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," he added.
Circadian rhythms with high levels in the morning and low levels at night, is lost in patients with adrenal insufficiency.
Treatment of adrenal insufficiency includes replacing missing or low levels of cortisol with synthetic steroids such as glucocorticoid, adrenal genital corticoids, and mineralocorticoid drugs.
Patients with adrenal insufficiency will need to take a steroid by mouth for the rest of their lives. Resulting dehydration and salt loss should be treated with an adequate fluid intake and a diet high in complex carbohydrate and protein.
Dangerously low blood pressure may require special medications to safely elevate it until the steroids take effect. Follow-up care includes frequent monitoring of blood sugar and urinary acetone levels and continued administration of the steroids.
Adrenal insufficiency occurs in about four in every 100,000 people. The condition can strike both men and women of all ages, but is more common in middle-aged women.