ACUTE PANCREATITIS


  • Acute pancreatitis is characterized by the sudden inflammation of the pancreas, a gland located behind the stomach, caused by the activation of the digestive enzymes within the pancreas itself.
  • Symptoms of acute pancreatitis include severe abdominal pain, nausea, vomiting, fever, and a rapid pulse. Severe cases can lead to complications such as pancreatic necrosis, infection, and organ failure.
  • The most common causes of acute pancreatitis include gallstones, excessive alcohol consumption, certain medications, infections, trauma, and high levels of triglycerides in the blood.
  • Treatment for acute pancreatitis usually involves hospitalization, intravenous fluids, pain management, and supportive care. If the underlying cause is identified, specific treatments may be implemented, such as gallstone removal.

LARGE UNMET MEDICAL NEED


  • 2nd most common acute surgical pathology.
  • Annual incidence: 15-100/100,000.
  • Global incidence estimated as ~2.6M cases per year.
  • +30% growth of incidence in 2009 - 2015.
  • ~20% of patients develop moderate/severe forms of the disease with in-hospital mortality of up to 35%.
  • Standard therapy treats symptoms and consequences (e.g. complications) of acute pancreatitis and is often ineffective.
  • No medicines have been approved specifically for the treatment of acute pancreatitis.

NO NEW TREATMENTS OF ACTUTE PANCREATITIS HAVE BEEN INTRODUCED SINCE 1970s


Complex Pathophysiology of Acute Pancreatitis

Standard therapy does not tackle root causes and key drivers of acute pancreatitis and is often ineffective
OUR SOLUTION

PandiCath®

  • Implement a novel multimodal method of treatment of acute pancreatitis.
  • Simultaneously tackles multiple pathological processes that underpin progression of the disease and development of its deadly complications.
Duodenal Installation of PandiCath®
Multiple treatment modalities of PandiCath®
include both commonly used and novel approaches
Multiple treatment modalities simultaneously conferred by PandiCath® aim to reduce the incidence of progression of acute pancreatitis to severe forms and to prevent development of its deadly complications. This will result in better outcomes for patients suffering from this dangerous disease.

Clinical Research with PandiCath®

  • A randomized, controlled, stratified, prospective, open-label, multicenter clinical study has been performed in order to evaluate effectiveness and safety of PandiCath® in combination with Standard of Care vs. Standard of Care alone in treating patients with moderate and severe acute pancreatitis.
  • The study has completed enrollment of patients in June 2023. Currently the data produced by the study is being reviewed and analyzed with preliminary results suggesting significant improvement of clinical outcomes for patients treated with PandiCath®.
  • For more details of the study design, conduct and preliminary results please contact us at info@pandica.com.

Preliminary results of the Proof-of-Concept study in treating acute pancreatitis with PandiCath®

Results for the modified Intention-To-Treat (mITT) population as randomized

Results for the modified Intention-To-Treat (mITT) population "as treated" ***

* Primary Composite Clinical EndPoint - Infectious or Non-Infectious complications or De-Novo MODS@≥96hrs or AP-related Mortality

** Number Needed to Treat - number of patients one needs to treat to prevent one bad outcome – measure of clinical effectiveness

*** For the purposes of the analysis, patients were assigned to the experimental Group 1 (PandiCath® + SoC) if they received “correct experimental treatment”. Otherwise patients were assigned to SoC Group 2.