Lodotra^™ – Asthma

Asthma is a chronic inflammatory disease of the airways that typically affects the bronchi, a system of airways that convey air into and out of the lungs. Inflammation can be triggered by multiple factors including allergens, cold air, exercise, airborne irritants and respiratory infections. The resulting inflammation can lead to reversible airway obstruction, airway inflammation and hyper-responsiveness. Together, these components of the disease cause the symptoms of asthma, such as wheezing, shortness of breath, cough and excess mucus production.

Severe asthma is life-threatening and visits to the emergency room are not uncommon. Sufferers of severe asthma frequently experience nocturnal symptoms, such as cough and dyspnoea (shortness of breath) accompanied by a nocturnal drop in lung function The nocturnal symptoms are caused by circadian variations in airway inflammation, specifically an increase in pro-inflammatory cytokines. In addition, nocturnal symptoms also appear to be associated with mortality from asthma with the majority of respiratory arrests and sudden deaths in subjects with asthma occurring between midnight and 8am.

Lodotra^™ As asthma symptoms are usually more severe during the night, the administration of standard prednisone in the morning appears to be suboptimal as inflammatory cytokine levels have already peaked and receded by the time of need. By delivering prednisone at the time of need, Nitec believes that Lodotra^™ will offer significant advantages over standard therapy including efficacy at low dose resulting in an improved side effects profile. This may reduce the severe side effects associated with current standard treatments, which rely on high doses of prednisone. Nitec is conducting a phase 2 trial to investigate the ability of Lodotra^™ to treat severe asthma.

Market size The prevalence of asthma across the seven major pharmaceutical markets (the US, Japan, France, Germany, Spain, Italy and the UK) was estimated at 53 million people, a rate of 7.7 %. In the US alone, the annual direct health care cost of asthma is approximately US$ 14.7bn with indirect costs (e.g., lost productivity) of another US$ 5bn. Nitec believes that about 5 % of these have severe asthma and take oral glucocorticoids on a regular basis. Severe asthma is a life-long disorder and requires treatment with pharmaceuticals for the duration of a patient’s life.