LAVAL, QC, CANADA, ROCKVILLE, MD, USA and CAMBRIDGE, UK – June 14, 2019 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic), a biopharmaceutical company focused on developing novel therapeutics to treat unmet needs in patients with liver, respiratory and kidney disease, today announced that four abstracts highlighting Prometic’s progress in developing PBI-4050 as a potential treatment for both acute kidney injury (AKI) and chronic kidney disease (CKD) will be presented at the 56th Congress of the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA). The Congress will take place on June 13 - 16, 2019 in Budapest, Hungary.
“These pre-clinical results provide additional evidence demonstrating the anti-fibrotic activity of PBI-4050 and therefore its potential as a novel therapy for the treatment of AKI and CKD,” stated Kenneth Galbraith, Chief Executive Officer of Prometic. “We are encouraged by these results, which provide additional support for our decision to expand our development plans for PBI-4050 in fibrosis-related renal indications in 2020.”
An oral presentation will discuss the mechanism of action of PBI-4050 onto GPR40 and GPR84, two promising biological targets in the treatment of kidney fibrosis. Results from cellular and animal models of acute and chronic kidney injuries, including data demonstrating that PBI-4050 reduced biomarkers associated with kidney injury from a previously-completed Phase 2 clinical study in patients with Type 2 diabetes and metabolic syndrome, will be presented by Dr. Lyne Gagnon, Prometic’s Vice-President R&D, Preclinical, on June 14, 2019 at 8:00 a.m. CEST.
Three poster presentations will highlight the role of the two G protein-coupled receptors, GPR40 and GPR84, in various models of kidney injury and associated complications. The following posters will be presented:
-PBI-4050 Reduces Systemic Inflammation, Electrolyte Disturbances and Renal Injury in Mice with Sepsis-induced Acute Kidney Injury; Role of GPR84 (#FP266, June 14, 2019, 9:30 to 10:45 and 16:30 to 17:00).
-Activation of the Free-fatty Acid Receptor GPR40 Improves Anemia in Mouse Models of Kidney Disease Via a Novel EPO-Independent Mechanism of Action (#SP345, June 15, 2019, 9:30 to 10:45 and 16:30 to 17:00).
-PBI-4050 Improves Metabolic Regulation and Diabetic Nephropathy through Reduction of ER Stress, Pro-Inflammatory/Fibrotic Markers, Galectin-3 Expression and Inflammatory Cell Infiltration in ob/ob Mouse Model (#SP436, June 15, 2019, 9:30 to 10:45 and 16:30 to 17:00).
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 our lead drug candidates’ anti-fibrotic activity in several key organs including the kidneys, lungs, liver and the heart.
About Prometic Life Sciences
Prometic (www.prometic.com) is an innovative biopharmaceutical corporation with a broad pipeline of small molecule therapeutics under development to treat unmet needs in patients with liver, respiratory and kidney disease, including rare diseases. Prometic's differentiated research involves the study of a new antifibrotic pathway involving two G-protein-coupled-receptors, GPR40 and GPR84. These drug candidates have a dual mode-of-action as agonists ("stimulators") of GPR40 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 in 2019. A second drug candidate, PBI-4547, is expected to enter Phase 1 clinical studies in 2019. Prometic also has leveraged its experience in bioseparation technologies to isolate and purify biopharmaceuticals from human plasma. The lead plasma-derived therapeutic product is Ryplazim™ (plasminogen) for which the Company expects to file a BLA with the US FDA in 2019 seeking approval to treat patients with congenital plasminogen deficiency. The Corporation 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, the Isle of Man and the United Kingdom. For more information, please visit www.prometic.com.
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, 2018, 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.
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