Therapeutic Areas
COPD
Chronic Obstructive Pulmonary Disease (COPD) is a slow progressive disease comprised of chronic bronchitis and emphysema, and characterized by airflow limitation and decreased lung function.
Facts
According to the World Health Organization (WHO), COPD is currently the 4th leading cause of death worldwide and is projected to become the third one by 2030. In 2005, more than 3 million people died of COPD and in 2007, 210 million people were diagnosed with this disease.
Risk Factors
COPD is a preventable disease as its most important cause is tobacco smoking. Other significant risk factors for COPD are exposure to air pollutants, in particular burning of biomass fuels in developing countries, occupational dusts and chemicals, as well as respiratory infections.
Treatments
COPD is managed with inhaled bronchodilators (i.e., M3 muscarinic antagonist and β2 agonists) and corticosteroids. These different treatments help control the symptoms of the disease and increase the quality of life of the patients.
Unmet Needs
Compared to short-acting bronchodilators, the use of LAMAs is superior in improving health outcomes in COPD patients. For those whose symptoms are not adequately controlled by monotherapies, the use of a combination of more than one class of bronchodilator and an inhaled corticosteroid is recommended. Most COPD patients also have co-morbidities that require multiple therapies to be taken several times a day, some with delivery devices that are challenging to use, particularly for the elderly, leading to poor patient compliance and additional burden on quality of life.
Significant unmet needs exist for:
- A once-a-day dual therapy combining a LAMA with a long-acting β2 agonist (LAMA/LABA), and perhaps ultimately a triple therapy combining LAMA/LABA/IC in a single inhaler for the treatment of moderate to very severe COPD
- A once-a-day LAMA that can be nebulized for patients with severe COPD who are unable to actuate dry-powder inhalers (1.8 million patients in the US alone) and require the passive administration using a nebulizer
Due to this need, the goal of Theron's LAMA program is to develop a once-daily inhaled bronchodilator that possesses the adequate physicochemical properties for broad inhalation device flexibility (DPI, MDI & nebulizer) in addition to excellent co-formulation compatibility for use in multi-drug combination products (i.e., LAMA/LABA/IC or LAMA plus new drugs with novel mechanism of action). Theron believes that TRN-157 will have all of these critical attributes.
Uncontrolled asthma: a new opportunity for LAMAs
In patients with severe asthma who remain symptomatic despite treatment with low dose inhaled corticosteroids in accordance with guidelines, there is also strong support for adding LAMA (Peters et. al. NEJM, 2010) as a potential new therapeutic option to improve symptoms and lung functions. The pharmacological potency combined with the long duration of action of Theron's proprietary compounds together with their versatile device/drug compatibility could also provide the foundation for a broad range of combination products for severe asthma well into the future.