Lodotra^™ – Polymyalgia Rheumatica

Polymyalgia rheumatica (PMR) is an acute-onset rheumatic disease of the large arteries and is characterized by stiffness, pain or aching in the large muscle groups, especially around the shoulders and hips, headache, bilateral pain, as well as signs of adynamia (weakness), depression, and strong systemic inflammation. Stiffness is worse in the morning and is associated with an increase in pro-inflammatory cytokines during the night. Approximately 16%-21% of PMR patients also suffer from giant-cell arthritis, an inflammatory disease of the arteries that supply blood to the head and eyes, which can be fatal if untreated. PMR follows a proven circadian rhythm, which leads to symptoms which are more prevalent in the morning hours and after other long periods of rest. PMR is typically confined to the elderly, with the median age of onset being 72. The exact cause of PMR is unknown.

Lodotra^™
PMR is primarily treated by glucocorticoids to control symptoms, to preserve mobility, independence and quality of life and to minimise complications that can arise through the disease. As the symptoms of PMR are usually more severe during the night and in the early morning hours, the administration of standard prednisone in the morning is 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 doses resulting in an improved side effects profile. Nitec believes that Lodotra^™ has the potential to treat PMR more efficiently than current treatments with a lower dose of prednisone and is designing a label extension trial to investigate the ability of Lodotra^™ to treat PMR.

Market size
In Western populations, the prevalence of PMR is estimated at approximately 739 per 100,000 persons aged 50 or over, which implies a sufferer population of over 700,000 in the US and over 700,000 in the five largest European pharmaceutical markets (France, Germany, Italy, Spain and the UK). Women are around two times more likely to be affected by PMR than men.