Background

The inability of the adrenal glands to produce adequate levels of the vital stress hormone cortisol is described as adrenal insufficiency. This condition is associated with considerable mortality and morbidity. Most causes of adrenal insufficiency are permanent, but some causes are transient, in particular tertiary adrenal insufficiency (as a result of taking steroids for a condition such as arthritis or asthma and the commonest cause in children). In tertiary adrenal periodic diagnostic testing is required.

The Short Synacthen Test is the first line diagnostic test for adrenal insufficiency worldwide. Requests for this test have risen in line with increased steroid usage in children and the heightened awareness by healthcare professionals of the adrenal insufficiency steroids can cause. The current test requires invasive administration (intravenous or intramuscular) of Synacthen and blood sampling. The invasive nature of the test leads to a high threshold for investigation, especially in babies and children. A non-invasive test, requiring neither highly trained staff nor a day-care admission, is therefore highly desirable.

Technology Overview

Clinicians and researchers from the University of Sheffield and the Sheffield Children’s NHS Foundation Trust have developed a non-invasive test for the diagnosis of adrenal insufficiency. This test is based on a novel liquid formulation of tetracosactide and chitosan, which is supplied in a single-use delivery system. The formulation is delivered nasally and the test utilises saliva to measure the glucocorticoid response, negating the use of needles completely.

Stage of Development

Clinical trials performed to date have demonstrated that the nasal formulation, ‘Nasacthin’, is reliably absorbed and well tolerated. Pharmacokinetic analysis have shown that the novel formulation elicits maximal adrenal stimulation and an equivalent response to the standard Short Synacthen Test at 60 minutes, with an indistinguishable glucocorticoid response in adults and children.

Benefits

Timely diagnosis in increased numbers of patients at risk
Reduced inadvertent harm of long-term steroid use where not required
Non-invasive
Less resource intensive
Reduced costs for the healthcare provider
Utility in the inpatient, outpatient and community settings
Improved overall patient experience

Opportunity

Seeking co-development partner for pivotal clinical trial in adults and paediatric subjects
Available for exclusive and non-exclusive licensing

A Needle-free Adrenal Failure Diagnostic Test

Patents

IP Status

Seeking