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PROMETIC’S PBI-4050 TO TARGET CYSTIC FIBROSIS AS ITS NEXT ORPHAN INDICATION
Majority of cystic fibrosis (“CF”) patients develop diabetes and liver steatosis
PBI-4050 shown to reduce fibrosis in the lungs, pancreas and liver in preclinical models
PBI-4050 confirmed to reduce glycated hemoglobin in type 2 diabetes patients
Double-blind placebo-controlled phase II clinical trial to focus on pancreatic fibrosis, glucose intolerance and diabetes in CF patients
LAVAL, QUEBEC, CANADA – December 14, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced its plans today to initiate a double-blind placebo controlled phase II clinical trial in patients suffering from cystic fibrosis (CF) and related diabetes and liver steatosis. CF is a condition which affects approximately 70,000 individuals in North America and compromises their pulmonary, pancreatic and hepatic functions.
As a result of significantly improved standards of care over the past years, the average life expectancy for CF patients now surpasses 40 years. However, with a longer life expectancy, the genetic condition also generates serious pancreatic and hepatic complications. In particular, 70% of CF patients will have an abnormal glucose tolerance and, 35-40% of adult CF patients will have developed a unique type diabetes, a condition known as cystic fibrosis-related diabetes (CFRD). CFRD is associated with all the complications typical of diabetes, leading to progressive eye, kidney, peripheral nerve, and gastrointestinal tract damage.
Dr John Moran, Chief Medical Officer of ProMetic commented: “CFRD is a devastating complication of CF which adds to the already heavy burden of treatment and leads to a more rapid decline in lung function and a higher mortality. This double blind placebo controlled phase II clinical trial will investigate whether PBI-4050 can reverse fibrosis in the pancreas and help manage the glucose intolerance and related diabetic complications experienced by the CF patients. The clinical trial will also allow us to monitor the effects of PBI-4050 on other important parameters in CF patients, especially lung and liver function”.
“PBI-4050 has been shown to significantly reduce fibrosis in several key organs in preclinical models and this, irrespective of how the injuries were induced or whether they were acute or chronic in nature”, stated Dr Lyne Gagnon, VP of R&D preclinical at ProMetic. “For this reason and because of the positive effects recently observed in type 2 diabetic patients, we believe that PBI-4050 could provide significant clinical benefits to patients affected by this medical condition”.
According to Ms. Norma Beauchamp, Chief Executive Officer of Cystic Fibrosis Canada: “Much progress has been accomplished in recent years in treating cystic fibrosis, yet, cystic fibrosis remains a devastating medical condition seriously affecting various key organs and quality of life for those who suffer from it. Innovative therapies such as the one put forward by ProMetic and its lead anti-fibrotic compound could play a key role in alleviating some of the associated medical complications while further improving quality of life of people living with cystic fibrosis in Canada and around the world”.
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