Phoqus' Phase I study heralds first Circadian drug
researching its experimental treatment, which could become the
first Circadian endocrine treatment for adrenal insufficiency.
The treatment aims to provide a viable alternative to current steroid therapies for conditions that 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 (€111 million) per year.
Phoqus said that a sustained-release tablet using its technologies would address this need effectively and provide an effective treatment.
Phoqus has established a collaboration with Diurnal to develop Chronocort, a once daily modified release hydrocortisone tablet for the treatment of adrenal insufficiency, a condition that causes Addison's disease, hypopituitarism and congenital adrenal hyperplasia.
The initial Phase I trial 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.
"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," commented Andy Jones, Chief Executive Officer of Phoqus.
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.
Circadian rhythms with high levels in the morning and low levels at night, is lost in patients with adrenal insufficiency.
Patients diagnosed with adrenal insufficiency typically experience fatigue and loss of energy, loss of appetite, nausea, vomiting, diarrhea, abdominal pain, weight loss, muscle weakness, dizziness when standing, dehydration, anxiety and depression.
Unfortunately, significant symptoms are usually not noticed until about 90 per cent of the adrenal cortex has been destroyed.
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.
