- IP Status: Patent application submitted
- Seeking: Licensing, Commercial partner
Inhaled corticosteroids (ICS) have been used as ﬁrst line treatment of asthma and COPD for many decades.
ICS can suppress the endogenous production of cortisol, a condition known as adrenal suppression. Stopping the drugs, decreasing the dose or changing the type of ICS may trigger features of adrenal insuﬃciency.
Adrenal insuﬃciency may cause a spectrum of presentations varying from vague symptoms of fatigue to potentially life threatening acute adrenal crises.
Researchers at the University of Liverpool have identiﬁed a Single Nuclear Polymorphism (SNP) in a gene that increases the risk of developing adrenal suppression in children and adults using inhaled corticosteroids (ICS). This is believed to be the ﬁrst predictive adverse eﬀect polymorphism identiﬁed in asthma and COPD.
This biomarker could form the basis of a point of care predictive test to help develop personalised treatment plans for all patients with asthma, a disease that has multiple alternative treatment options but at present no suitable guidelines for treatment decision-making.
This biomarker could align well with other biomarkers that are predictive of ICS eﬃcacy in asthma. More broadly it could be used to select patients at risk of adrenal suppression in a wide range of illnesses treated with ICS (e.g. Duchennes MD, rheumatology, oncology, IBD).
The invention was discovered from a genome-wide association study to assess genomic factors aﬀecting responses to a Low Dose Short Synacthen Test (LDSST) in populations using corticosteroids. This test is used to monitor adrenal suppression in ‘at risk’ patients. Three cohorts of patients were investigated (499, 81 and 78 patients) and the association was found to be signiﬁcant in all individual cohorts. A meta-analysis of the entire patient sample gave a P value of 3.5 x 10-9. The presence of this mutation was found to triple a patient’s risk of adrenal suppression.
In 2017, there were estimated to be approximately 146 million patients globally suﬀering from asthma, with about half as many again suﬀering from COPD.
The market opportunity is to provide a test to identify the subsection of the patients who are at higher risk from adrenal suppression. This will enable clinicians to improve treatment and higher levels of patient support if they know a patient is in a high risk category. Asthma is ideally situated to implement this test as there are steroid alternative drugs, and maintenance therapy with steroids is undertaken electively allowing me for a patients genomic status to be ascertained.
The University of Liverpool is currently seeking a licensing partner to provide expertise in the commercialisation of the technology.