- PBI-4050 significantly reduced microparticles shedding from
the kidney and key renal biomarkers in diabetic and obese
patients
- PBI-4050 prevents diabetic nephropathy and damage to
pancreatic cells producing insulin in preclinical diabetic
model
- PBI-4050 reduces liver damage and insulin resistance in a
high fat diet preclinical model
- New data presented at the American Diabetes Association's
77th Scientific Sessions in San
Diego
LAVAL, QC, June 12, 2017 /PRNewswire/ - Prometic Life
Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) presented new data at
the 2017 American Diabetes Association (ADA)'s 77th Scientific
Sessions in San Diego. The data
presented included results from a Phase 2 clinical trial evaluating
PBI-4050 in 24 patients with metabolic syndrome and type 2 diabetes
(MST2D), as well as from preclinical studies demonstrating the
protective effect of PBI-4050 on the kidney, pancreas and liver in
diabetic animals.
New data from the completed Phase 2 trial, discussed in an
oral presentation, showed that, after 12 weeks of treatment with
PBI-4050, a statistically significant reduction of microparticles
shedding from the kidney in the patients' urine was observed.
Furthermore, a statistically significant reduction in key renal
biomarkers was also demonstrated in the same patients. "Taken
together, these data provide strong evidence that PBI-4050 protects
the kidney from the injury commonly observed in diabetic patients,"
explained John Moran, M.D., Chief
Medical Officer at Prometic. "This is supportive of our Phase 2/3
placebo-controlled clinical trial we intend to initiate in the
second half of 2017 in patients with late stage chronic kidney
disease and diabetes".
Lyne Gagnon, Ph.D., Vice President of Research and
Development at Prometic presented data providing further evidence
that the beneficial clinical effect of PBI-4050 is through a novel
mechanism regulating inflammation and fibrosis. "It is quite
compelling to see how PBI-4050 reduces damages in the liver, kidney
and pancreas in two new preclinical models which again translates
perfectly to what we have observed in the patients in our clinical
trial," stated Dr. Gagnon.
Oral presentation and posters at ADA:
PBI-4050 Reduces Key Cardiorenal Biomarkers and Urinary
Microparticles in Type 2 Diabetes Patients with Metabolic
Syndrome
PBI‐4050 Prevents Destruction of
β‐Cells and Islets, and Diabetic
Nephropathy in NOD Mice, a Model of Type 1
Diabetes
PBI-4050 Protects Against Renal Fibrosis and Improves
Pancreatic Function in High-Fat-Diet db/db Mouse
Model
PBI-4050 Improves Glucose Metabolism and Insulin
Resistance, and Reduces Liver Damage in a High-Fat Diet Mouse Model
of Obesity and Metabolic Syndrome
Oral Treatment with PBI-4547, a Novel Anti-Diabetic and
Anti-Fibrotic Compound: A Potential Therapy for Diabetes, Diabetic
Nephropathy, and Obesity
About PBI-4050 & PBI-4547
PBI-4050 and PBI-4547 are Prometic's orally active lead
drug candidates targeting fibrosis. PBI-4050 will be entering Phase
2/3 clinical trials after demonstrating efficacy and excellent
safety profiles in three Phase 2 open label clinical trials.
Prometic plans to initiate the next phase of clinical trials for
PBI-4547 in the fourth quarter of 2017. Fibrosis is a 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 with PBI-4050
confirms its anti-fibrotic activity in several key organs including
the kidneys, the heart, the lungs and the liver. PBI-4050 has
on-going clinical trials in patients with metabolic syndrome and
type 2 diabetes, cystic fibrosis with related diabetes and Alström
Syndrome. The planned Phase 2/3 clinical trials scheduled to
commence this year target patients with idiopathic pulmonary
fibrosis (IPF) and chronic kidney disease (CKD). Twenty-six million
patients in the U.S. alone are believed to suffer from 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 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 number of industry leaders.
The company uses its own affinity technology, which provides for
highly efficient extraction and purification of therapeutic
proteins from human plasma, 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 fields 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 U.K., the U.S. and Canada,
manufacturing facilities in the U.K. 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, 2016, 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.