- IPF and Alström Syndrome; Top priorities for PBI-4050
clinical development
- Unique anti-fibrotic mechanism of action supporting
rationale for the development of first-in-class drug
candidates
- Plasminogen to target acute acquired deficiencies and wound
healing
LAVAL, QC, Feb. 20, 2018 /CNW Telbec/ - Prometic
Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
("Prometic") today provided an update regarding its clinical
development programs and confirmation of its priorities regarding
its lead drug candidates.
PBI-4050 and follow-on analogs, PBI-4547 &
PBI-4425
"Idiopathic pulmonary fibrosis (IPF) is now priority No.1 for
PBI-4050" stated Pierre Laurin,
President and CEO of Prometic. "IPF remains to this day a
significant unmet medical need affecting hundreds of thousands of
patients with an established market value measured in $billions.
The clinical efficacy demonstrated so far in multiple phase 2
clinical trials combined with an impressive safety and tolerability
profile gives us great confidence in PBI-4050's ability to
efficiently address fibrotic diseases."
Following the outcome of the successful clinical development
Type C meeting held with the FDA in early January 2018, the top clinical development
program priority is now the phase 3 pivotal clinical trial for
PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF). The
all comers study will enroll patients with mild-to-moderate IPF,
regardless of whether they are on background standard of care with
nintedanib (OFEV®) or not and will provide efficacy data
on both PBI-4050 as a stand-alone agent, and as an add-on to
nintedanib, and will be part of the dataset to support a simple,
all-inclusive indication for the treatment of IPF. This
multinational study, involving multiple sites across the United States, Canada, Australia, the UK and Europe is expected to begin patient enrollment
around the 2018 mid-year mark.
Following last year's confirmation that beneficial clinical
effects are sustained during prolonged treatment in subjects
suffering from Alström Syndrome in the United Kingdom, further extensions of duration
of treatment were announced to Prometic's on-going phase 2 open
label clinical trial. Prometic now announces that it is formally
seeking meetings with both the European and the US regulatory
authorities to determine the clinical-regulatory pathway for this
condition as a stand-alone indication.
Pierre Laurin stated: "We will
soon be disclosing further clinical data from the on-going Alström
Syndrome clinical trial in the UK which also gives us great
confidence to pursue this devastating condition as a stand-alone
fibrosis indication to be treated with PBI-4050. Safety and
efficacy data collected and demonstrated to date in such a
challenging patient population will also contribute to the clinical
design and potential treatment for future clinical development
initiatives of the Corporation with respect to indications such as
heart, kidney & liver fibrosis".
As part of this realignment, the Corporation has terminated
PBI-4050 clinical trial in Cystic Fibrosis Related Diabetes
("CFRD") and is evaluating the need to continue other on-going
clinical programs with PBI-4050. Prometic is evaluating its
clinical development strategy regarding follow-on compounds (i.e.
analogs of PBI-4050) which share the same unique mechanism of
action with PBI-4050, have demonstrated similar performance in
multiple preclinical studies and some of which have outperformed
PBI-4050 in specific animal models. Clinical development of
those analogs would enable Prometic to target other
fibrotic-related indications and create further therapeutic
products optionality for our on-going partnering discussions.
These realignments therefore include: The commencing of
PBI-4547's clinical program includes the initiation of the phase 1
clinical trial in Q2 2018 followed by a phase 2 in patients with
liver fibrosis and metabolic diseases. It further includes
the initiation of PBI-4425's clinical program which is scheduled to
commence in H2 2018 with specific targeted indications to be
communicated in H2 2018.
Ryplazim™ for plasminogen deficiencies
Ryplazim™ (plasminogen) is the first biopharmaceutical expected
to be launched commercially pending the review of its BLA (Biologic
License Application) submitted to the FDA initially for the
treatment of congenital plasminogen deficiency.
The Company will prioritize the expansion of clinical
indications for Ryplazim™ and leverage the positive clinical
experience gained by supplementing plasminogen levels in deficient
patients. There are several medical conditions, some of which
potentially lethal, associated with "acquired plasminogen
deficiencies" and Prometic is designing clinical trials to
establish optimal dosing protocols for the potential use of
Ryplazim™ for the treatment of such conditions, including
thrombotic events as well as acute exacerbations in patients with
acute respiratory distress syndrome (ARDS) and/or IPF.
Clinical trials with sub-cutaneous Plasminogen in patients with
diabetic foot ulcers and in patients with Tympanic perforations are
also currently being conducted in Sweden with expected interim clinical data
readouts later this year.
The expenses related to the IVIG non-inferiority phase 3
clinical trial will decrease in 2018 with the completion in H1 2018
of the adults' cohort required for the FDA BLA filing to be
followed by the completion of the pediatric cohort in H1
2019.
Commenting on the financing strategy required to execute on
these plans, Bruce Pritchard,
Prometic's CFO noted, "At this stage in its development, the
Corporation requires a financing strategy that allows it to
maintain adequate capitalization as it continues to build
enterprise value with its strong pipeline of therapeutics, but that
also recognizes the need for a combination of: generating revenue
through product sales; generating revenue from leveraging the asset
base, such as licensing technologies for non-core indications or
geographies and monetizing priority review vouchers; effective use
of debt and synthetic royalty structures and by accessing capital
from long-term institutional investors under the best possible
conditions". He added, "Each element of this plan is
critical, and is being actively pursued by management.
Investors should be assured that no single component of the
strategy is been seen as mutually exclusive to another. Most
importantly, all components need to be readily deployable as
required, as we continue to plan to execute a timely secondary
listing on NASDAQ".
To maintain its flexibility for strategic fund-raising, Prometic
has filed a preliminary short form base shelf prospectus (the
"Preliminary Shelf Prospectus") with the securities
commissions in each of the provinces of Canada.
Mr. Pritchard went on to explain, "The establishment of a shelf
prospectus is common practice among our Canadian and US
Peers. Prometic is somewhat unusual for not having one in
place. Today's filing of such a shelf prospectus adds to our
armory of financing choices".
The Preliminary Shelf Prospectus, when made final or effective,
will allow Prometic to offer up to $250,000,000 of common shares over the 25-month
period that the Shelf Prospectus is effective. The Shelf Prospectus
will enable Prometic to potentially access new capital as and when
needed. The amount and timing of any future offerings will be based
on the Company's financial requirements and market conditions at
the time. The specific terms of any future offering under the Shelf
Prospectus will be established at the time of such offering. At the
time any of the securities covered by the Shelf Prospectus are
offered for sale, a prospectus supplement containing specific
information about the terms of such offering will be filed with
applicable Canadian securities regulatory authorities. The
Preliminary Shelf Prospectus filed today with the Canadian
securities regulatory authorities has not yet become effective. No
securities may be sold, nor may offers to buy be accepted, prior to
the time the Preliminary Shelf Prospectus becomes effective. This
news release shall not constitute an offer to sell or a
solicitation of an offer to buy, nor shall there be any sale of
these securities in any jurisdiction in which an offer,
solicitation or sale would be unlawful prior to registration or
qualifications under the securities laws of any such
jurisdiction. A copy of the Preliminary Shelf Prospectus can
be found on SEDAR at www.sedar.com or may be obtained upon request
to Prometic's Investor Relations Department using the contact
information set out below.
About Prometic Life Sciences Inc.
Prometic Life Sciences Inc. (www.prometic.com) is a
biopharmaceutical corporation with two drug discovery platforms
focusing on unmet medical needs in the field of fibrosis and orphan
diseases. The first platform, small molecule therapeutics, stems
from the discovery of two receptors GPR40/GPR84 acting as dual
master-switches which are at the core of the healing process as
opposed to fibrosis. The second platform, plasma-derived
therapeutics, leverages Prometic's vast experience in bioseparation
technologies to address unmet medical needs with therapeutic
proteins not currently commercially available, such as Ryplazim™
(plasminogen human). Prometic is also leveraging the second
platform higher recovery yield advantage to develop some more
established plasma-derived therapeutics with significant growth in
demand such as Intravenous Immunoglobulin (IVIG) and provides
access to its proprietary bioseparation technologies to enable
pharmaceutical companies in their production of non-competing
biopharmaceuticals. Globally 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. 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.