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ProMetic's PBI-4050 meets primary and secondary end points in metabolic syndrome and type 2 diabetes Phase 2 clinical trial

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  • Clinically and statistically significant reduction of glycated hemoglobin ("HbA1c") originally observed at 12 weeks is maintained at 24 weeks of treatment
  • Clinically and statistically significant reduction of waist circumference (a fundamental metabolic syndrome criterion)
  • Statistical improvement of new biomarkers related to kidney injury
  • Placebo-controlled clinical trial to commence this quarter

LAVAL, QC, Oct. 20, 2016 /CNW Telbec/ - ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") announced today that its Phase 2 clinical trial in patients with metabolic syndrome and type 2 diabetes has been completed and has met its primary and secondary endpoints. In addition to safety and tolerability, the study was designed to evaluate the effect of PBI-4050 on metabolic syndrome parameters as well as on pro-inflammatory/fibrotic and diabetic biomarkers in blood and urine.

In this open label Phase 2 clinical trial, PBI-4050 (800 mg) was administered once daily to 24 patients for a period of 12 weeks.  Ten of these patients were enrolled in an additional 12 weeks extension. PBI-4050 has been well tolerated with no serious drug related adverse events.

The fundamental physical criterion for the diagnosis of metabolic syndrome is waist circumference. The patients experienced a clinically and statistically significant reduction in waist circumference in 12 weeks, with a mean change of -1.5 cm (p = 0.009). A strong trend in weight and Body Mass Index ("BMI") reduction was also observed (p = 0.06 and 0.07, respectively).

The pharmacological activity of PBI-4050 was confirmed through the clinically significant reduction in HbA1c between screening and Week 12. For instance, the 15 patients with a screening HbA1c ≥ 7.5 experienced a mean decrease of - 0.75% (p = 0.0004) while the 9 patients with a screening HbA1c ≥ 8.0% experienced a mean decrease of - 0.9% (p = 0.007). The 10 patients who participated in the study's 12 week extension had a mean HbA1c of 7.7 at screening and experienced a reduction of - 0.8% at week 12: this reduction was maintained at week 24.

 

Diabetes & Metabolic biomarkers in blood

Changes from baseline

P-value

Fasting insulin

- 19%

0.017

Fasting C-Peptide

- 11%

0.028

Adiponectin

+ 18%

0.021

FGF-21

+ 29%

0.024

Vaspin

+40%

0.027

 

"It is clearly of interest that the improvement in HbA1c was associated with a decrease in fasting insulin and C-peptide, indicating that the improvement in HbA1c is, at least in part, explained by a reduction in insulin resistance", according to Dr John Moran, ProMetic's Chief Medical Officer. "This is supported by the fact that the patients with the greatest reductions in their HbA1c values had the highest increase in adiponectin levels. Higher plasma adiponectin levels are known to protect diabetic patients from vascular complications and to improve their insulin sensitivity", added Dr Moran.

Several biomarkers measured in blood or urine of patients and associated with a high incidence of cardiovascular complications and kidney injury when elevated in metabolic syndrome were significantly reduced by PBI-4050.

 

Biomarkers for kidney (urine)

Changes from baseline

P-value

IL-18

-31%

0.017

Calbindin

-31%

0.042

Cystatin C

-20%

0.011

KIM-1

-22%

0.035

TFF3

-15%

0.036

 

More data will be disclosed during the forthcoming annual meetings of the American Heart Association in New Orleans (Nov 14) and of the American Society of Nephrology in Chicago (Nov 18) and at the Corporation's analyst day scheduled for November 21 in NYC.

"We are pleased to see that PBI-4050 continues to deliver the same solid results in patients with metabolic syndrome and type 2 diabetes, but what is perhaps even more interesting is the meaningful reduction in biomarkers which when elevated are associated with cardiovascular and kidney complications", commented Mr. Pierre Laurin, CEO of ProMetic. "This provides us with very valuable confirmation of efficacy in important parameters ahead of our upcoming placebo controlled clinical trials", added Mr. Laurin.

More on Metabolic Syndrome

Metabolic syndrome is a major risk factor for cardiovascular disease and for Type 2 diabetes, and consists of the constellation of central (truncal) obesity, high blood triglycerides, low HDL ("good") cholesterol, elevated blood pressure, and elevated blood glucose. Obesity is believed to cause a chronic inflammatory state, which leads to insulin resistance and so may in turn result in cardiovascular disease and/or Type 2 diabetes. Given the global epidemic of obesity, both in the developed and developing world, the metabolic syndrome and its consequences present a devastating public health problem. It is difficult to grasp the numbers and the overwhelming public health issues presented by the global epidemic of obesity, the metabolic syndrome, and Type 2 diabetes. The International Diabetes Federation estimates that in 2013 there were 300 million diabetics world-wide, and that that number will increase to 600 million by the year 2035. The Centers for Disease Control estimates that 34% of US adults have the metabolic syndrome, and that 1 of 3 children born in the U.S. during the year 2000 will develop diabetes during their lifetime.

MORE ABOUT PBI-4050

PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in several in vivo experiments targeting fibrosis. Fibrosis is a very complex process by which continuing inflammation causes vital organs to lose their function as normal tissue is replaced by fibrotic scar tissue. The proof of concept data generated to date confirms our lead drug candidates' anti-fibrotic activity in several key organs including the kidneys, the heart, the lungs and the liver. Twenty six million patients in the U.S. alone are believed to suffer from chronic kidney diseases ("CKD"). Patients with severe CKD stages (3 and 4) suffer from a progressive loss of their renal function leading to end-stage renal disease and the need for dialysis or kidney transplant. Cardiovascular complications are the most common cause of death in dialysis patients.

About ProMetic Life Sciences Inc.        

ProMetic Life Sciences Inc. (www.prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and commercial activities in the U.S., Canada, Europe, Russia, Asia and Australia.

Forward Looking Statements

This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in ProMetic's Annual Information Form for the year ended December 31, 2015, under the heading "Risk and Uncertainties related to ProMetic's business". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.

 

SOURCE ProMetic Life Sciences Inc.

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