- Prometic moving immediately to formalize enrollment of
specialist clinical sites across the United States
- U.S. IND to be followed by clinical trial applications in
Canada, Europe, Australia and Japan throughout Q4 2017
- Prometic plans to supplement the IND with a protocol for a
study of PBI-4050 monotherapy in IPF patients in October 2017
LAVAL, QC, Sept. 25, 2017 /PRNewswire/ - Prometic Life
Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today
announced that its oral anti-fibrotic lead drug candidate,
PBI-4050, has received U.S. Food and Drug Administration
Investigational New Drug (IND) approval to commence its pivotal
Phase 2/3 clinical trial in patients suffering from idiopathic
pulmonary fibrosis (IPF).
The pivotal Phase 2/3 clinical trial is a two-stage adaptive,
randomized, double-blind, placebo-controlled study designed to
evaluate the efficacy and safety of PBI-4050 when combined with
nintedanib (OFEV™, Boehringer Ingelheim) in subjects with IPF. The
number of subjects required to be enrolled has been based on the
results seen in the recently-completed open label study of PBI-4050
in IPF. The Phase 2 stage will enroll 375 subjects with IPF, who
will be randomly assigned to one of three groups: 1) 125 subjects
who will receive placebo + nintedanib, 2) 125 subjects who will
receive PBI-4050 800 mg + nintedanib or 3) 125 subjects with
PBI-4050 1200 mg + nintedanib. An independent Data and Safety
Monitoring Board (DSMB) will conduct an interim 26-week analysis,
and based on the safety and efficacy results, will recommend
whether the study should continue into Phase 3 stage and which dose
of PBI-4050 should be continued. This Phase 3 stage
would randomize an additional up to 450 subjects to receive
nintedanib plus either placebo or the chosen PBI-4050 dose.
Prometic has already completed an open label Phase 2 study in
patients who received PBI-4050 for 12 weeks in addition to either
pirfenidone, nintedanib, or placebo. The study showed the Forced
Vital Capacity (FVC) remained stable in patients on PBI-4050 alone
(n=9, FVC -12 ml) and in patients on PBI-4050 in combination with
nintedanib (n=15, FVC +2 ml). In contrast, the FVC declined
significantly in patients receiving PBI-4050 in combination with
pirfenidone (n=16, FVC -105 ml). PBI-4050's plasma concentration
was sub-therapeutic at 50% of the expected level in patients
receiving PBI-4050 in combination with pirfenidone, suggesting a
drug-drug interaction.
"We are very encouraged by the results of our open-label trial
of PBI-4050 in combination with nintedanib, and are pleased to
advance the clinical development plan with this pivotal study",
said Dr. John Moran, Prometic's
Chief Medical Officer. "IPF is a very serious condition and we
believe that patients may benefit from this novel therapeutic
approach. We have multiple key opinion leaders who have expressed a
wish to participate in the study, and now that the IND has been
cleared we can begin a formal study startup".
Pierre Laurin, Prometic's
President and Chief Executive Officer, stated, "We are very excited
to be entering the pivotal stages of our IPF clinical program,
which is another important milestone towards bringing this therapy
to patients who suffer from IPF. We believe that PBI-4050 is
an important advancement in this indication and represents a
potential significant step forward for helping patients".
More about Idiopathic Pulmonary Fibrosis ("IPF")
Idiopathic pulmonary fibrosis (IPF) is a chronic, devastating,
and ultimately fatal disease characterized by a progressive decline
in lung function. It is a specific type of interstitial lung
disease in which the small air sacs of the lung, the "alveoli,"
gradually become replaced by fibrotic (scar) tissue and is the
cause of worsening dyspnea (shortness of breath). IPF is usually
associated with a poor prognosis. The term "idiopathic" is used
because the cause of pulmonary fibrosis is still unknown. IPF
usually occurs in adult individuals of between 50 and 70 years of
age, particularly those with a history of cigarette smoking, and
affects men more often than women. IPF affects about 130,000 people
in the United States, with about
48,000 new cases diagnosed annually. Approximately 40,000 people
with IPF die each year, a similar number of deaths to those due to
breast cancer. The 5-year mortality rate for patients with IPF is
estimated to range from 50% to 70%.
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 the anti-fibrotic
activity of PBI-4050 in several key organs including the kidneys,
the heart, the lungs and the liver. It is also effective in
improving glucose control in animal models of diabetes. Open label
Phase 2 studies in idiopathic pulmonary fibrosis and in Type 2
diabetes have provided preliminary evidence that the results seen
in preclinical models translate into the corresponding human
diseases.
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 is active in developing its own novel
small-molecule therapeutic products targeting unmet medical needs
in the field of fibrosis, cancer and autoimmune
diseases/inflammation. A number of plasma-derived and small
molecule products are under development for orphan drug
indications. Prometic also 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. 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 and Asia.
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.