Asthma is a major chronic inflammatory disease of the airways affecting an estimated 300 million people worldwide. In OECD countries, prevalence is around 10% and increasing, with greater than average prevalence amongst women, children, and the elderly.
The main symptoms are wheezing, coughing, chest tightness, and shortness of breath.
Although many new insights into the disease have been garnered over recent years, the basic treatment paradigm remains largely unchanged: corticosteroids are used to reduce inflammation and bronchodilators relax smooth muscle contraction in the airways. For many patients, the current standard of treatment works reasonably well in controlling the disease, despite the well-documented side-effects of persistent corticosteroid use.
However, the actual causes of the disease are not addressed, leading to continual need for medication and therefore loss of quality of life. Additionally, a considerable number of patients do not respond well to conventional therapy. With SB010, sterna biologicals aims to provide a novel form of inhaled treatment directed against the underlying disease mechanisms.
Recently, asthma has been found to be a heterogeneous disease with different phenotypes. SB010 is intended for a distinct subset of asthmatic patients exhibiting moderate to severe Th2-driven asthma. This asthma phenotype is well-characterised by conventional diagnostic parameters as well as by our proprietary biomarker, which we are developing in parallel to our clinical programme.
Atopic Dermatitis is a chronic inflammatory disease of the skin characterised by an itchy rash. The skin reacts to normally harmless irritants such as allergens and develops an immune response, often compounded by bacterial surface infections as the skin becomes dry or damaged. Frequently, atopic dermatitis is accompanied by other allergic conditions such as asthma or hay fever.
In developed countries, approximately 1-3% of adults and 5-20% of children are affected by atopic dermatitis.
Standard treatment is usually via dermal application of corticosteroids or other anti-inflammatory dermal formulations. In more severe cases, systemic therapy is required through corticosteroids or cyclosporine A. Additionally, immunosuppressive drugs are available but have been required by the FDA to carry a black box warning regarding increased cancer risk. None of the available therapy options actually addresses underlying disease causes and requires constant medication.
Sterna biologicals is developing SB011 for atopic dermatitis, a dermal formulation of its GATA-3 DNAzyme
Psoriasis is a chronic immune-mediated disease of the skin. The immune system malfunctions and mistakenly targets the skin. T cells, in particular Th1 cells that usually protect the body against infections, migrate to the dermis, thereby initiating an inflammatory response. Excessive skin cell growth commences, leading to the disease's characteristic skin manifestations, which can in severe cases cover a patient's entire body.
The disease can be painful and accompanied by itching. Moreover, visible symptoms can lead to a significant reduction in quality of life, including depression, social isolation, and occupational limitations.
Approximately 2% of the population in developed countries is affected by psoriasis.
A variety of dermal formulations, including corticosteroids, are used to treat mild forms of psoriasis, in addition to phototherapy. In severe cases, systemic application of immunosuppressive drugs is required, for example monoclonal antibodies targeting key cytokines that cause inflammation, such as TNF-α. Since these drugs down regulate the part of the immune system designed to fight infections, the body becomes more susceptible to viruses. Recently, a monoclonal antibody for the treatment of psoriasis was withdrawn from the market due to a series of fatal brain infections.
SB020, sterna biologicals' drug candidate for the treatment of psoriasis, represents a novel therapeutic approach by directly inhibiting Th1 cell activation and subsequent inflammatory mechanisms.
Chronic obstructive pulmonary disease (COPD) is a disease of the lung comprising chronic bronchitis (inflammation) and emphysema. It is the fourth leading cause of death in the US and affects an estimated 4-10% of the population in developed countries.
The main characteristic of the disease is airflow limitation that is not fully reversible. Local inflammation in the airways leads to narrowing and destruction of lung tissue, impeding lung function. Over time, symptoms tend to worsen. COPD is primarily caused by long-term exposure to tobacco smoke or air pollution.
Similar to asthma, the main treatment options for COPD include inhaled corticosteroids to reduce inflammation and bronchodilators (such as β2 agonists or anticholinergics) to relax smooth muscle contraction in the airways. Oral PDE-4 inhibitors are also approved to reduce inflammation.
Sterna biologicals is currently developing SB021 for the treatment of COPD as a novel inhaled therapy option.^top