Vision
To shape the future of patient care through accelerated development of safe drugs targeted at ion channels.
Business Model
CyThera Pharmaceuticals is committed to the development of the highest quality products through repositioning of FDA-approved drugs for new disease indications in cancer, stroke and immune disease. The company’s core competency centers on compounds screened against ion channel proteins. Based on patented technology, we are developing a topical cream that is predicted to resolve psoriatic skin lesions. The same technology is being developed as a pill to fight Multiple Sclerosis and Rheumatoid Arthritis.
Classic Drug Discovery vs Drug Repurposing
CyThera accelerates the development of autoimmune therapeutics by repurposing existing FDA-approved drugs. Medical product development through drug repurposing is both rapid and cost effective and can generate return on investment (ROI) within 4-6 years. CyThera leverages the 505(b)(2) New Drug Application pathway for FDA approval, a fast and cost-effective strategy to bring repurposed drugs to market
For its first product, Cythera Pharmaceuticals is developing a topical cream against the skin disease psoriasis ($4.7 billion global market by 2016). This will serve as proof-of-concept (POC) to expand the technology’s use for other autoimmune diseases, including a cream for Vitiligo ($2 billion) and systemic administration for Multiple Sclerosis ($11 billion).
Autoimmune Diseases
Autoimmune diseases occur when the body’s immune system attacks and destroys healthy body tissue by mistake. The white blood cells (T and B lymphocytes) in the body’s immune system normally help protect against harmful intrusions, including bacteria, viruses, toxins, cancer cells, and blood and tissue from outside the body. These substances contain antigens and the immune system produces antibodies against these antigens that enable it to destroy these harmful substances.
In patients suffering from an autoimmune disorder, the immune system is misguided and does not distinguish between healthy tissue and foreign antigens. As a result, the body sets off reactions that can change the organ's function, lead to abnormal growth of an organ (e.g., Psoriasis), or even destroy its own normal tissues (e.g., Multiple Sclerosis, Diabetes Type 1).
The exact cause of autoimmune disorders is unknown. One theory is that some microorganisms (such as bacteria or viruses) or drugs may trigger changes that confuse the immune system. This may happen more often in people who have genes that make them more prone to autoimmune disorders. There are more than 100 types of autoimmune disorders affecting 50 million people in the U.S. alone.
In patients suffering from an autoimmune disorder, the immune system is misguided and does not distinguish between healthy tissue and foreign antigens. As a result, the body sets off reactions that can change the organ's function, lead to abnormal growth of an organ (e.g., Psoriasis), or even destroy its own normal tissues (e.g., Multiple Sclerosis, Diabetes Type 1).
The exact cause of autoimmune disorders is unknown. One theory is that some microorganisms (such as bacteria or viruses) or drugs may trigger changes that confuse the immune system. This may happen more often in people who have genes that make them more prone to autoimmune disorders. There are more than 100 types of autoimmune disorders affecting 50 million people in the U.S. alone.
Repurposing Drugs to Treat Autoimmune Diseases
Psoriasis is a serious, noncontagious and chronic skin autoimmune disease that carries severe physical, mental and socioeconomic burdens on 3% of the world’s population, or approximately 125 million people. People with psoriasis are also at increased risk for other disorders connected to the immune system, including heart conditions, diabetes and lupus. According to the National Institutes of Health (NIH), 2-3% of Americans have psoriasis. It is estimated that this patient pool loses about 56 million hours of work and spends about $$2-$3 billion to treat the disease every year.
There are numerous treatments for psoriasis, ranging from over-the-counter to prescription drugs, including topical creams and systemic therapeutics taken as a pill or injectable biologicals, some of which suppress the patient’s entire immune defense system. These treatments are often ineffective or can have severe side effects or, as in the case of biologicals, are poorly or not at all reimbursed by insurers. Topical applications remain the first line of treatment in 50-80% of all psoriasis patients, regardless of disease severity, but have poor efficacy efficacy. CyThera is developing a topical cream containing a drug that selectively inhibits the activity of so-called memory T lymphocytes, which are known to play a major role in psoriasis. Delivering an easy to use, safe, and highly effective cream to patients suffering from psoriasis would satisfy an unmet need and potentially capture a significant portion of the psoriasis drug market.
There are numerous treatments for psoriasis, ranging from over-the-counter to prescription drugs, including topical creams and systemic therapeutics taken as a pill or injectable biologicals, some of which suppress the patient’s entire immune defense system. These treatments are often ineffective or can have severe side effects or, as in the case of biologicals, are poorly or not at all reimbursed by insurers. Topical applications remain the first line of treatment in 50-80% of all psoriasis patients, regardless of disease severity, but have poor efficacy efficacy. CyThera is developing a topical cream containing a drug that selectively inhibits the activity of so-called memory T lymphocytes, which are known to play a major role in psoriasis. Delivering an easy to use, safe, and highly effective cream to patients suffering from psoriasis would satisfy an unmet need and potentially capture a significant portion of the psoriasis drug market.
If successful in treating psoriasis, the same cream could prove beneficial in treating other skin diseases in which memory T cells participate, including atopic dermatitis, vitiligo, or cutaneous lupus erythematosus. The cream's main ingredient, or pharmaceutically enhanced analogs of it, could further be used in pill form to treat systemic autoimmune diseases such as psoriatic or rheumatoid arthritis, multiple sclerosis, or juvenile diabetes.
