Prometic Life Sciences Inc. 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).
- 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
LAVAL, QC, April 30, 2018 /PRNewswire/ -- 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 safety issues.
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.
Summary of Serious Bacterial Infections (SBI) -------------------------------------------- Parameter Total Episodes Annualized Rate --------- -------------- --------------- Commercial Prometic Commercial Prometic Product IGIV 10% Product IGIV 10% --- ------- SBI 0 0 0 0 --- --- --- --- ---
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.
Summary of Secondary Efficacy Endpoints --------------------------------------- Parameter Commercial Prometic Product IGIV 10% --- ------- ------- Number of episodes of fever (>= 100.4°F) --------------------------------------- Annualized rate with 95% CI 0.44 (-0.15, 1.03) 0.56 (-0.31, 1.43) --------------------------- ----------------- ----------------- Number of missed days from school/work -------------------------------------- Annualized rate with 95% CI 13.45 (4.85, 22.06) 4.94 (1.80, 8.09) --------------------------- ------------------ ---------------- Number of days of hospitalization due to infection -------------------------------------------------- Annualized rate with 95% CI 0.09 (-0.09, 0.27) 0 (NA, NA) --------------------------- ----------------- --------- Number of days of antibiotic use (prophylaxis and treatment) ----------------------------------------------------------- Annualized rate with 95% CI 17.03 (9.72, 24.33) 16.73 (10.25, 23.21) --------------------------- ------------------ ------------------- Number of infections other than SBI ----------------------------------- Annualized rate with 95% CI 2.80 (1.94, 3.66) 2.49 (1.71, 3.26) --------------------------- ---------------- ---------------- Trough IgG level (mg/dL) ------------------------ Mean (SD) 1119.293 (257.5755) 1078.192 (217.0420) -------- ------------------ ------------------
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 post-infusion. Overall Prometic IGIV 10% appeared to be well tolerated and was not associated with any SBIs.
“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 (click here).
About IVIG
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%).
About Prometic
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, 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.
