Castle Creek Pharma has assembled a robust and well diversified portfolio of innovative and high potential late stage drug candidates in development for the treatment of a number of important diseases. Castle Creek Pharma’s products are advancing rapidly through development and have the potential to enter the market within 2-3 years.
Specialty Dermatology and ENT
Epidermolysis Bullosa Simplex
- Epidermolysis bullosa simplex (EBS) is the most common form of epidermolysis bullosa, a rare dermatologic condition where patients (many of them children) have a genetic defect that compromises the structural integrity of their skin, making it particularly fragile and prone to blistering throughout their bodies. The disease can be severely debilitating and there are no treatment options currently available.
- CCP-020 (diacerein 1% ointment) is a new drug in development for the treatment of EBS. It is a potentially disease modifying therapy that blocks an important inflammatory signaling pathway in EBS.
- The DELIVERS study is evaluating the safety and efficacy of CCP-020 (diacerein 1% ointment) for the treatment of EBS. For more information, visit http://deliversebs.com/ or see the study listing at ClinicalTrials.gov.
- Vertigo is a sensation caused by an imbalance in the signals from the body’s sensory balance organs, including the eyes and inner ears, or by the way such signals are interpreted by the brain. It is commonly perceived as instability, a feeling of rotation or the sensation of dizziness, and it is often associated with lack of balance, nausea and vomiting. Vertigo is a common condition, can be highly debilitating and may lead to significant injury from falls and other accidents.
- CCP-030 (Arlevert®) is a fixed-dose oral combination tablet containing 20 mg cinnarizine and 40 mg dimenhydrinate. It is approved in multiple European Union countries for the treatment of vertigo of various origins. The active ingredients work together both peripherally and centrally to reduce the symptoms of vertigo.
Premalignant Oral Lesions
- Oral cancer accounts for approximately 3% of all malignancies in the United States, and approximately 25,000-30,000 cases of oral cancer are diagnosed each year. In addition, oral cancer is one of the most common malignancies in Southeast Asia, accounting for up to 30-40% of all malignancies in India. Despite recent medical advances, the 5-year survival rate for oral cancer is only 50-60%. Many oral squamous cell carcinomas develop from premalignant oral lesions, which include leukoplakia, erythroplakia, and oral lichen planus. The rate of progression to malignancy has been reported to be as high as 17.5%.
- CCP-042 is in development for the treatment of premalignant oral lesions.
Other Areas of High Medical Need
- Lysosomal storage disease refers to a group of rare genetic disorders in which critical enzymes involved in a cell’s metabolism are defective or deficient, leading to the accumulation of toxic substances in a part of the cell called the lysosome. Lysosomal storage disease manifests itself in different ways, often affecting multiple organ systems, and varying levels of morbidity and mortality.
- CCP-010 is a molecular chaperone that is being developed as the first treatment option for patients with GM2 Gangliosidosis (Tay Sachs and Sandhoff disease), a lysosomal storage disorder associated with significant neurologic morbidity and mortality, and for which there are no treatment options available.
Urea Cycle Disorders
- Urea cycle disorders (UCDs) are a group of rare genetic metabolic disorders in which patients cannot properly metabolize waste nitrogen from nitrogen containing substances, and as a result experience elevated ammonia levels that rapidly rise to toxic levels.
- CCP-110 is a novel mechanism drug in development for the treatment of hyperammonemia in UCDs that acts by “trapping” ammonia ions in the gut and rapidly excreting them from the body.