ProMetic to investigate PBI-4050 for cystic fibrosis, steatosis

ProMetic Life Sciences Inc. announced its plan to initiate a phase 2 clinical trial investigating its drug candidate, PBI-4050, for the treatment of cystic fibrosis and related diabetes and liver steatosis.

“This double-blind placebo controlled phase 2 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 [cystic fibrosis] patients,” John Moran, chief medical officer of ProMetic, said in a press release. “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 is an oral drug candidate that has been investigated in vivo for targeting fibrosis, according to the ProMetic website. In the release, ProMetic states that CF leads to serious pancreatic and hepatic complications. More specifically, 70% of patients with CF will have an abnormal glucose tolerance and between 35% and 40% of adult patients will have developed cystic fibrosis-related diabetes.

Preclinical models have shown evidence of PBI-4050 reducing fibrosis in the lungs, pancreas and liver. In addition, it has reduced glycated hemoglobin in type 2 diabetes patients, according to the release.

“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,” Lyne Gagnon, vice president of research and development preclinical at ProMetic, said in the release. “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.”

Disclosure: Moran and Gagnon are employed by ProMetic.