- New data suggest PBI-4547 offers potential as novel therapy for
liver fibrosis, nonalcoholic steatohepatitis (NASH), nonalcoholic
fatty liver disease (NAFLD), diabetes and obesity
- New data to be presented at the 2018 American Diabetes
Association conference
LAVAL, QC, June 22, 2018 /CNW Telbec/ - Prometic
Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(Prometic) today announced the presentation of four posters at
the American Diabetes Association's 78th Scientific
Sessions taking place in Orlando,
Florida, June 22 – 26, 2018.
The posters and data to be presented at the conference
suggest that PBI-4547 offers the potential to successfully address
significant unmet medical needs in liver fibrosis, nonalcoholic
steatohepatitis (NASH), nonalcoholic fatty liver disease (NAFLD),
obesity and diabetes.
"We have seen that our late stage candidate PBI-4050's reduction
of fibrosis in the heart and liver in preclinical models has
translated to clinical activity in patients with Alström Syndrome
("AS")," commented Dr. John Moran,
Chief Medical Officer of Prometic. "PBI-4547's performance on
the liver in preclinical models is more impressive, especially in
the context of concomitant diabetes, elevated cholesterol and
triglycerides. As we progress PBI-4547 into the clinic in the
second half of 2018, we anticipate demonstrating the same
translation to clinical activity not only in NASH but also in other
selected orphan diseases."
Pierre Laurin, CEO of Prometic,
commented: "With PBI-4050's demonstrated clinical activity in
humans in three phase 2 clinical trials, including the AS patients
with established severe liver fibrosis and cirrhosis, advancing
PBI-4547 into the clinic provides us with even more optionality in
the positioning of our drug candidates and partnering
discussions."
Key data presented at the conference in four poster
presentations entitled:
"PBI-4547 Improves Glucose Metabolism and Insulin Resistance,
and Reduces Liver Damage in a High-Fat Diet Mouse Model of Obesity
and Metabolic Syndrome"
"PBI-4547 Prevents Progression of Prediabetic Condition to
Type 1 Diabetes in NOD Mice"
"PBI-4547 Reverses Diabetes and Metabolic Syndrome through
Regulation of Lipid/Glucose Metabolism, β-Oxidation and Fibrosis in
Liver and White Adipose Tissue in ob/ob Mice"
"PBI-4050 Improves Metabolic Regulation and Diabetic
Nephropathy through Reduction of ER Stress,
Pro-Inflammatory/Fibrotic Markers, Galectin-3 Expression and
Inflammatory Cell Infiltration in ob/ob Mouse Model"
Key observations from these presentations included:
- In a mouse model of high-fat-diet induced obesity and metabolic
syndrome, PBI-4547: 1) improved glucose metabolism by reducing
insulin resistance and preserving β-cell function. 2) reduced
hepatic steatosis and ballooning., 3) reduced serum triglycerides
and increased adiponectin level and 4) regulated pro-inflammatory /
fibrotic gene expression in liver and adipose tissues.
- In an ob/ob mouse model, PBI-4547 reduced blood glucose,
cholesterol and triglyceride levels, as well as
pro-inflammatory/pro-fibrotic markers in liver and adipocyte size
and fibrosis in white adipose tissue. PBI-4547 increased serum
adiponectin and modulated biomarkers associated with glucose and
lipid metabolism, fibrosis, mitochondrial metabolism and browning
of adipose tissue.
- In a prediabetic type 1 NOD mouse model, PBI-4547 significantly
prevented the evolution to severe diabetes, resulting in increased
survival.
- In an ob/ob mouse model, PBI-4050 improved triglycerides and
glucose metabolism, reduced collagen and galectin-3 deposition in
white adipose tissue and kidney and reduced ER stress and
pro-inflammatory/fibrotic markers in kidney.
About NASH
"NASH", or nonalcoholic steatohepatitis, is a liver disease
characterized by an accumulation of fat (lipid droplets), along
with inflammation and degeneration of hepatocytes. Once installed,
the disease is accompanied with a high risk of cirrhosis, a state
where the liver functions are altered and can progress to liver
insufficiency. Thereafter, the NASH often progresses to liver
cancer.
About PBI-4547
PBI-4547 is an orally active drug candidate and analogue to
PBI-4050. Prometic has observed that the "up-regulation" of
receptor GPR40 concomitant to the "down-regulation" of receptor
GPR84 promotes the normal healing process as opposed to promoting
the fibrotic process. PBI-4547 like PBI-4050 are agonists
("stimulators") of GPR40 and antagonists ("inhibitors") of GPR84.
GPR40 and GPR84 are known to be involved in diverse physiological
processes related to metabolic regulation and to inflammation, but
the fundamental importance of these receptors in the fibrosis
pathways had not been recognized until now. Prometic uncovered a
novel antifibrotic pathway involving these receptors, showing that
GPR40 is protective and GPR84 is deleterious in fibrotic diseases.
Through its binding to these receptors, PBI-4050 and PBI-4547 can
attenuate fibrosis in many injury contexts, as evidenced by the
global antifibrotic activity observed in the kidney, liver, heart,
lung, pancreas, or skin.
About Prometic
Prometic (www.prometic.com) is a biopharmaceutical corporation
with two drug discovery platforms focusing on unmet medical needs.
The first platform (small molecule therapeutics) stems from the
discovery of two receptors which we believe are at the core of how
the body heals: namely, promoting tissue regeneration and scar
resolution as opposed to fibrosis. One of the lead drug candidates
emerging from this platform, PBI-4050, is expected to enter pivotal
phase 3 clinical trials for the treatment of Idiopathic Pulmonary
Fibrosis (IPF). The second drug discovery and development platform
(plasma-derived therapeutics) leverages Prometic's experience in
bioseparation technologies used to isolate and purify
biopharmaceuticals from human plasma. The Corporation's primary
goal with respect to this second platform is to address unmet
medical needs with therapeutic proteins not currently commercially
available, such as Ryplazim™ (plasminogen). We are also leveraging
this platform's higher recovery yield potential to advance
established plasma-derived therapeutics such as Intravenous
Immunoglobulin (IVIG). Furthermore, the Corporation is continuing
to secure its plasma supply through the execution of third party
contracts and expansion of its own collection activities for its
plasma processing needs. The Corporation also provides access to
its proprietary bioseparation technologies to enable pharmaceutical
companies in their production of non-competing biopharmaceuticals.
Recognized as a bioseparations expert, the Corporation derives
revenue from this activity through sales of affinity chromatography
media which contributes to offset the costs of its own R&D
investments.
We are headquartered in Laval, Quebec
(Canada) and have R&D facilities in Canada, the United
Kingdom ("UK") and the United
States ("USA"), manufacturing facilities in Canada and the Isle
of Man and corporate and business development activities in
Canada, the USA, and Europe.
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, 2017, 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.
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SOURCE ProMetic Life Sciences Inc.