Optimising Health Through Physiological Hormone Replacement
The following product information was taken from the Diurnal website.
Diurnal has created its pipeline of enhanced product opportunities by evaluating therapeutic indications within the endocrine area where current therapies are considered to be sub-optimal and could be superseded with more effective physiological hormonal replacement products.
Chronocort – first-in-class physiological cortisol replacement product for the life-long treatment of adrenal insufficiency and congenital adrenal hyperplasia.
Rheumacort– anti-inflammatory treatment to alleviate the symptoms of rheumatoid arthritis.
Native Oral Testosterone – first-in-class physiological native oral testosterone replacement treatment for hypogonadism.
Tri4Combi – goal to be the best-in-class thyroid hormone replacement treatment for patients with
Chronocortis the first-in-class physiological cortisol replacement product for the life-long treatment of adrenal insufficiency and congenital adrenal hyperplasia.
The body’s inability to produce the important metabolic hormone cortisol comes in two forms: adrenal insufficiency (acquired) and congenital adrenal hyperplasia (genetic). There are over 250,000 patients worldwide who are unable to produce the healthy required amounts of cortisol.
Cortisol has a distinctive daily rhythm and, currently, there are no effective products for the treatment of cortisol deficiency. Chronocort is specifically designed to provide physiological cortisol replacement over the whole day. Chronocort is administered at bedtime and provides overnight coverage of cortisol as well as sustained replacement during the following day.
Diurnal has successfully completed human volunteers studies of Chronocort and has initiated a Phase 2 trial in patients, the results of which are expected during 2013. It is expected that submission of a market authorisation for Chronocort will occur by the end of the 2017.
This work is supported by the European Commission through its 7th Framework Programme under the TAIN project. TAIN stands for Treatment of Adrenal Insufficiency in Neonates and Infants.
The aim of TAIN is to develop a new formulation of hydrocortisone – Infacort – that can be used from birth and specifically in the age range 0 – 2 years (neonates & infants). Hydrocortisone is an essential glucocorticoid hormone used as a replacement therapy for the treatment of the rare disease Adrenal Insufficiency – where the body cannot produce sufficient cortisol. The problem of effective hydrocortisone replacement is especially acute in this young patient range where no licensed therapy exists.
TAIN involves European partners who along with Diurnal are leaders in drug development, neonatology and paediatric pharmacology. A Paediatric Investigation Plan has been developed that will enable clinical trials to be carried out to provide sufficient evidence of safety and efficacy for Infacort to allow submission of a Paediatric Use Medicines Authorisation (PUMA) to the European Medicines Agency by the end of 2015.
TAIN also aims to raise awareness of Adrenal Insufficiency by working closely with parents, patient groups and clinicians. This will allow the work being conducted through TAIN to benefit the widest possible amount of children, their families and health professionals.
Further information and project updates can be found at: www.tain-project.org
Rheumacort is a novel anti-inflammatory treatment aimed at alleviating the symptoms of rheumatoid arthritis.
Rheumatoid arthritis is a disease that affects over 1% of western populations and there are more than 2.5M sufferers in the US alone.
Alleviating the symptoms of rheumatoid arthritis, such as morning stiffness, is a key goal in this area.
Rheumacort is currently undergoing pre-clinical evaluation by Diurnal and our partners.
Native Oral Testosterone
Diurnal is developing a first-in-class physiological native oral testosterone replacement treatment for patients suffering from hypogonadism.
Hypogonadism (testosterone deficiency) is estimated to affect 1% of men and has an estimated market size of at least 800M (USD $1.25B; Euro 900M) per annum worldwide. Often hypogonadism is under-diagnosed and recent studies show that the patient and market size could be significantly higher.
Currently, there is no oral formulation of native testosterone available because testosterone is quickly removed by the liver. The only currently available oral forms are either alkylated or esterified and are sub-standard therapies that present well documented significant pharmacokinetic variability and long-term safety issues.
Diurnal has successfully completed in vivo pre-clinical studies of its novel formulation and expects to initiate Phase 1 studies in humans during 2012.
Tri4Combi will be the first physiological combination therapy of the thyroid hormones T3 (triiodothyronine) and T4 (thyroxine) for patients suffering from hypothyroidism.
Hypothyroidism is common affecting up to 5% of people over 60 years and has an estimated market size of 800M (USD $1.25B; Euro 900M) per annum worldwide.
Despite conventional thyroxine replacement being widely available, more than 25% of patients with hypothyroidism report significantly impaired quality of life with medical and social economic consequences. Commercially available combination products of T3 and T4 do not provide physiological replacement and at best are titrated empirically (by the physician) based on symptomatic responses.
Diurnal has completed an initial formulation development programme to enable the selection of a suitable drug delivery technology to underpin its clinical development programme in this area. Diurnal is actively seeking partners to progress the Tri4Combi programme.