- Novel, orally active immuno-metabolic agent
- Potential therapy for NAFLD/NASH, metabolic syndrome and other
liver diseases
- Fully owned and proprietary to Prometic
LAVAL, QC, ROCKVILLE, MD and CAMBRIDGE, United Kingdom, Sept. 9, 2019 /CNW Telbec/ - Prometic Life
Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic), a
biopharmaceutical company focused on developing novel therapeutics
to treat unmet needs in liver, respiratory, and kidney diseases,
announced today that the first subject has been dosed in a Phase I
clinical study of PBI-4547. PBI-4547 is a novel, orally active
immune-metabolic agent which displays antidiabetic,
antihyperlipidemic, anti-inflammatory and anti-fibrotic activity as
shown in multiple animal models.
"We are excited to progress our second small molecule
anti-fibrotic compound into clinical studies consistent with
our new strategy to focus the cash resources from our strengthened
financial position primarily on the development of a portfolio of
novel anti-fibrotic compounds in multiple therapeutic categories,"
said Kenneth Galbraith, Prometic's
Chief Executive Officer, who added, "We continue to make progress
on both our discussions with the FDA and EMA in order to commence
Phase 3 clinical studies of our lead small molecule compound,
PBI-4050, in patients with Alstrom Syndrome, and the filing of our
proposed BLA amendment with the FDA for RyplazimTM
(plasminogen)".
The current clinical study is designed to assess the safety,
tolerability and pharmacokinetics of single ascending doses of
PBI-4547 in healthy subjects (ClinicalTrials.gov Identifier:
NCT04068259). A total of 40 adult participants will sequentially
receive 1 of 5 doses of PBI-4547 or matching placebo, with each
cohort of 8 participants randomized in a 3:1 ratio to receive
PBI-4547 or matching placebo. The Phase 1 clinical study is being
conducted by the CRO, Syneos, at locations in Quebec City and Montreal, QC, Canada.
Nonalcoholic Steatohepatitis (NASH) is a multi-faceted disease
including metabolic dysregulation, chronic inflammation and
fibrosis. In relevant animal models, PBI-4547 displays activity
against each of these aspects of the disease.
More About PBI-4547
PBI-4547 is part of a novel class compounds discovered by
Prometic with primary activity against a group of GPCR's known as
free fatty acid receptors ("FFAR's"). The target family has a dual
mode of action on inflammation and fibrosis. We have observed
activity in various inflammatory preclinical models with compounds
targeting the class. Prometic is currently evaluating
multiple compounds in this class aimed at activity across several
fibrotic and inflammatory conditions in respiratory, liver and
kidney disease, with a primary focus on orphan conditions.
PBI-4547 is a novel, orally active small molecule that is a
GPR84 antagonist, GPR40 (FFAR1)/GPR120 (FFAR4) agonist, and a
partial activator of peroxisome proliferator-activated receptors
(PPAR). PBI-4547 treatment significantly improved metabolic
regulation of glucose and lipids, and reduced hepatic steatosis,
ballooning and overall NAFLD (non-alcoholic fatty liver disease)
score in high fat diet (HFD)-fed mice. Fatty acid oxidation and
expression of mitochondrial uncoupling proteins were increased by
PBI-4547 in the liver. Metabolomic profiling demonstrated that the
metabolic dysregulation induced by HFD was abolished by PBI-4547.
Preclinical studies suggest that PBI-4547 offers the potential as a
novel therapy for NAFLD/NASH, metabolic syndrome and other liver
diseases.
PBI-4547 is an investigational drug and its safety and efficacy
have not yet been established.
For information about the Phase 1 clinical study with PBI-4547:
please visit http://www.clinicaltrials.gov
About Prometic
Prometic (www.prometic.com) is an
innovative biopharmaceutical company with a broad pipeline of small
molecule therapeutics under development to treat unmet needs in
patients with liver, respiratory and kidney disease, with a focus
on rare or orphan diseases. Prometic's research involves the study
of several G-protein-coupled-receptors, GPR40, GPR120 and GPR84,
known as free fatty acid receptors (FFAR's). These drug candidates
have a novel mechanism of action as agonists ("stimulators") of
GPR40 and GPR 120, and antagonists ("inhibitors") of GPR84. Our
lead drug candidate, PBI-4050, is expected to enter Phase 3
clinical studies for the treatment of Alström Syndrome after
approval by the FDA and EMA. A second drug candidate, PBI-4547, is
in a Phase 1 clinical study.
Prometic also has leveraged its experience in bioseparation
technologies to isolate and purify biopharmaceuticals from human
plasma. The lead plasma-derived therapeutic product is RyplazimTM
(plasminogen) which the Company expects to file a BLA with the US
FDA the first half of 2020 seeking approval to treat patients with
congenital plasminogen deficiency. The Company also operates a
contract development and manufacturing operation in the
United Kingdom, deriving revenue
through sales of affinity chromatography media.
Prometic has active business operations in Canada, the United
States, Isle of Man and the
United Kingdom.
Forward Looking Statements
This presentation 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 the
Annual Information Form for the year ended December 31, 2018, under the heading "Risks 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.
For more information, please visit www.prometic.com.
SOURCE ProMetic Life Sciences Inc.