Clinical data presented at the Clinical Immunology Society Annual Meeting in Toronto, Canada on April 27-28, 2018
Pivotal clinical trial meets primary and secondary endpoints
Clinical data demonstrates comparable efficacy to commercially-approved drugs
Prometic IVIG’s safety and tolerability profiles maintained without any significant drug related issues
Positive Results from IVG Phase 3 Trial
LAVAL, QUEBEC, CANADA – April 30, 2018 – Prometic Life Sciences Inc. (TSX: PLI)
(OTCQX: PFSCF) (Prometic) today announced positive clinical data from its pivotal IVIG phase
3 clinical trial, meeting its clinical primary and secondary endpoints in adult patients suffering from
primary immunodeficiencies (PID). The clinical data presented at the Clinical immunology Society
Annual Meeting in Toronto on April 27-28 2018 on Prometic’s IVIG demonstrated comparable
safety and efficacy data to existing commercial IVIG products without any significant drug related
Primary End Point
The primary end point is the rate of clinically documented serious bacterial infections (SBIs),
defined as bacterial pneumonia, bacteremia and septicemia, osteomyelitis/septic arthritis,
bacterial meningitis or visceral abscess. The FDA Guidance for Industry on studies required to
support marketing of IGIV states: “…a statistical demonstration of a serious infection rate per
person-year less than 1.0 is adequate to provide substantial evidence of efficacy”. Since there
were no SBIs observed during the study, Prometic IGIV 10% clearly meets this requirement.
Secondary endpoints including episodes of fever (≥100.4°F), number of missed days, number of
days of hospitalization due to infection, number of days on antibiotics, number of infections other
than SBI, and trough IgG level were comparable between Prometic’s IGIV and commercial drugs.
Only 4.94 days/subject/year were lost from work with Prometic IGIV 10%, which was significantly
less than the rate observed while on commercial product.
The proportion of infusions for which at least one treatment-emergent adverse events (TAAE) that
was reported was well within FDA guidance threshold across all time points within 72-hours postinfusion. Overall Prometic IGIV 10% appeared to be well tolerated and was not associated with
“The results with Prometic IGIV 10% met the FDA Guideline requirements for both safety and
efficacy. This is the second plasma derived therapeutic clinical program to generate positive
pivotal phase 3 results” said Pierre Laurin, President and CEO of Prometic. “This demonstrates
the ability of our PPPSTM platform to generate positive data from both rare proteins targeting rare
diseases as well as more commodity like proteins”.
The poster presented at the Clinical Immunology Society Annual Meeting in Toronto is available
on Prometic’s corporate website.
What is Intravenous Immunoglobulin?
Intravenous immunoglobulin is a preparation of antibodies purified from plasma donations from
healthy individuals. It is indicated for the maintenance treatment of patients with primary
immunodeficiencies (PID), including common variable immunodeficiency, X-linked
agammaglobulinemia and severe combined immunodeficiency. It is also indicated for the
treatment of immune thrombocytopenic purpura (ITP) and for many other autoimmune diseases,
including Guillain-Barré syndrome, Kawasaki disease.
According to recent market data, Canada is ranked as the second country in the world after the
United States for the average consumption of IVIG (measured in kilograms per million people),
with sales exceeding $600 million in 2016. The global IVIG market CAGR is expected to reach
5-6% between 2016 and 2025 with Canada having one of the lowest IVIG self-sufficiency ratios
(i.e. less than 20%).
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.
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.
For further information please contact:
President and CEO
Prometic Life Sciences Inc.
Senior Director, Communications & Investor Relations
Prometic Life Sciences Inc.
Matt Middleman, M.D.
LifeSci Public Relations