News Out! PROMETIC’S PBI-4050: EFFICACY FURTHER EVIDENCED IN TYPE 2 DIABETIC
AND METABOLIC SYNDROME CLINICAL TRIAL
New results from additional patients increase statistical and clinical
evidence of efficacy.
Reduction of glycated hemoglobin (HbA1c) reaches -0.9% (p=0.0004) in
patients with HbA1c ≥ 8% at baseline
PBI-4050 continues to improve other physical parameters related to
metabolic syndrome (waist circumference, body weight and body mass
index)
LAVAL, QUEBEC, CANADA, – April 26, 2016 – ProMetic Life Sciences Inc. (TSX:
PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced today that new data
including an additional nine patients enrolled in its PBI-4050 phase 2 open label study in
patients suffering from type 2 diabetes and metabolic syndrome confirms the efficacy
initially reported in the first 11 patients that had completed the treatment period in
December, 2015. In these additional nine patients, administration of PBI-4050 resulted
in similar pharmacological activity on the diabetic and metabolic parameters, including
the decrease in HbA1c as was shown in the original 11 patients.
Dr. Moran, ProMetic’s Chief Medical Officer explained: “This ongoing clinical study
enabled us to confirm that PBI-4050 can be safely added to a cocktail of
antihyperglycemic drugs in diabetic patients with elevated HbA1c. With results now
available from twenty patients, we are also able to see the effect in a larger number of
patients with elevated HbA1c levels of > 7.5% or even ≥ 8%, which is the typical inclusion
criterion of other diabetic drug clinical trials. In the thirteen patients enrolled with an
HbA1c > 7.5%, we observed an average decrease of -0.75% (p=0.0004). This average
decrease was -0.9% in seven patients with HbA1c levels of ≥ 8% (p=0.0004).These
results compare very favorably with commercially available antidiabetic drugs. We have
clear evidence that PBI-4050 provides significant benefit when added to routine therapy
with oral antidiabetic agents”, concluded Dr. Moran.
A recent and comprehensive review of randomized controlled clinical trials involving
24,163 patients that studied the effect of commercially approved antihyperglycemic drugs,
DPP-4 inhibitors, on HbA1c reported an average reduction of -0.77%, with a mean
baseline HbA1c value of 8%.
Dr. Peter Senior, Professor of Medicine and Director of the Department of Endocrinology
at the University of Alberta, the principal investigator for the clinical trial, commented:
“This drug continues to demonstrate a consistent efficacy and safety profile in patients
with Type 2 diabetes. We also noticed that the level of HbA1c rose in most patients within
one month after completing the study’s course and ceasing to receive PBI-4050. This
rise of HbA1c after “washout” is strong evidence of a true benefit of PBI-4050”.
“PBI-4050’s reduction of HbA1c in our open label trial is a very strong efficacy signal that
provides us with very valuable insight for the placebo controlled clinical trial design in
patients with Chronic Kidney Disease with diabetes and in patients with metabolic
syndrome and diabetes”, commented Pierre Laurin, CEO of ProMetic. “We are very
confident about the prospect of PBI-4050’s clinical performance in the other on-going
clinical trials and the placebo controlled studies we are initiating”, added Mr. Laurin.
The Corporation previously disclosed the clinical programs of PBI-4050 to include
placebo controlled studies in patients with cystic fibrosis and related diabetes, patients
with chronic kidney disease and diabetes, patients with scleroderma and patients with
idiopathic pulmonary fibrosis. Further updates on the various PBI-4050 clinical programs
will be provided during the forthcoming Annual Meeting of Shareholders to be held on
May 11, 2016.