Gluten is a protein present in wheat and other cereal grains. In people with celiac disease, gluten triggers an immune reaction. It is estimated that celiac disease affects 1 in 100 people worldwide. Celiac disease causes significant health problems, including acute gastrointestinal symptoms, malnutrition, weakness, and failure to thrive. Celiac disease can develop at any age and, if left untreated, can lead to additional serious health problems.
Currently, the only treatment available for celiac disease patients is a strict gluten-free diet, which is challenging to maintain. For celiac patients attempting to maintain a gluten-free diet but who may accidentally ingest gluten, KumaMax has the potential to degrade the immune-reactive parts of gluten before they exit the stomach to decrease an immune response and reduce the symptoms and intestinal damage associated with celiac disease.
Before it is available commercially to patients, KumaMax will need to go through clinical trials as part of the FDA regulatory approval process. Clinical trials are designed to determine if a medicine is safe and effective for patients.
PvP Biologics has initiated two Phase 1 clinical trials. The Phase 1 clinical trials will study safety, tolerability, and pharmacodynamics and have begun enrolling approximately 80 adults at two sites. The first site at Michigan Medicine, the academic medical center at the University of Michigan, is enrolling normal volunteers. The second site in Anaheim is enrolling normal volunteers as well as patients with biopsy-confirmed celiac disease and who are maintaining a strict gluten-free diet.
In addition, you can visit ClinicalTrials.gov for a database of clinical trials around the world. ClinicalTrials.gov provides patients, their family members, and the public with easy and free access to information on clinical studies for a wide range of diseases and conditions.