Date: 2016-05-18
Type of
information: Clinical trial authorization
phase: 2
Announcement: clinical trial authorization
Company: ProMetic Life Sciences (Canada)
Product: PBI-4050
Action
mechanism:
- antifibrotic agent. PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in several in vivo experiments targeting fibrosis.
Disease: cystic fibrosis-related diabetes
Therapeutic
area: Fibrotic diseases - Metabolic diseases
Country:
Trial
details:
Latest
news:
- • On May 18, 2016, ProMetic Life Sciences reported that it had been approved to commence the clinical trial of its orally active anti-fibrotic lead drug candidate, PBI-4050, in patients suffering from cystic fibrosis, following the CTA clearance by Health Canada. The objectives of this 24 week randomized, double-blind, and placebo-controlled Phase 2 study includes the evaluation of the effects of PBI-4050 on pancreatic and lung function in 90 CF patients. ProMetic has recently reported a statistically and clinically significant decrease in HbA1C levels that compares very favorably to drugs already approved and marketed for the treatment of diabetes as well as additional evidence of PBI-4050’s pharmacological and clinical activity in humans based on the analysis of new pro-inflammatory biomarkers in blood and urine samples from these patients.
- • On December 14, 2015, ProMetic Life Sciences announced its plans to initiate a double-blind placebo controlled phase II clinical trial in patients suffering from cystic fibrosis and related diabetes and liver steatosis.
As a result of significantly improved standards of care over the past years, the average life expectancy for cystic fibrosis 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 cystic fibrosis patients will have an abnormal glucose tolerance and, 35-40% of adult cystic fibrosis 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.
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”.
Is
general: Yes
