LAVAL, QUEBEC, CANADA and CAMBRIDGE, UK – May 22, 2019 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today announced the presentation of three scientific posters on the Company’s lead small molecule and plasma-derived drug product candidates, respectively PBI-4050 and Ryplazim™ (plasminogen), on lung fibrosis indications, at the American Thoracic Society (ATS) 2019 International Conference taking place in Dallas, Texas, from May 17 – 22, 2019.
“These pre-clinical results provide additional evidence demonstrating the anti-fibrotic activity of PBI-4050 and its potential as a novel therapy for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Importantly, PBI-4050 has now been demonstrated to reduce fibrosis in two models of pulmonary fibrosis, commented Dr. Lyne Gagnon, Vice President of Preclinical R&D at Prometic. “Furthermore, the results in the acute lung injury (ALI) models suggest that supplementation with plasminogen may be of benefit in acute exacerbations of IPF as well as in treatment of ALI”, added Dr. Gagnon.
Dr. John Moran, Prometic’s Chief Medical Officer, commented: “PBI-4050 has repeatedly performed well in multiple, pre-clinical fibrosis-related animal models as well as in early, exploratory clinical trials. We are very pleased to see these results, which provide additional support in our decision to proceed with further clinical development of PBI-4050 in patients with IPF. We are planning a randomized, placebo-controlled, phase 2 clinical study of PBI-4050 in patients with IPF to be initiated later in the year.
Key data and observations presented by in the two PBI-4050 related poster presentations entitled “PBI-4050 Attenuates Bleomycin-Induced Lung Fibrosis by Reducing Fibrosis, Inflammation and ER Stress” and “Antifibrotic Effect of PBI-4050 in Human Normal and IPF Lung Fibroblasts, and in AdTGF-β1-Induced Pulmonary Fibrosis Rat Model”, included:
- PBI-4050 protected mice from bleomycin-induced pulmonary fibrosis, with reduced fibroblast activation and collagen deposition, reduced expression of profibrotic and inflammatory markers and of markers of ER stress.
- In another IPF model, the TGF-β1- induced pulmonary fibrosis rat model, performed under the supervision of Dr. Martin Kolb at McMaster University, PBI-PBI-4050 reduced collagen deposition and fibrosis, improved lung function and was at least as efficacious as pirfenidone or nintedanib.
- In lung fibroblasts cultured from IPF patients, PBI-4050 inhibited myofibroblast activation and returned mRNA expression of profibrotic and extracellular matrix markers to control levels.
Key data and observations presented in the RyplazimTM (plasminogen) related poster presentation entitled “Plasminogen Supplementation Therapy May Be a Good Add-On for the Treatment of IPF Exacerbations”, included:
- In the bleomycin-induced lung fibrosis model plasminogen administration led to reduced collagen deposition and fibrosis and mRNA expression of profibrotic and inflammatory markers.
- In two established models of ALI (sepsis-induced and L-arginine-induced) plasminogen administration reduced fibrin deposition and inflammation, congestion and hemorrhage in the lungs.
- Most importantly, blood plasminogen activity was found to be reduced in ALI models.
- In a post-hoc analysis of Prometic’s open-label Phase 2 IPF clinical study, blood plasminogen activity was found to be lower in subjects defined as non-responders based on the changes in forced vital capacity (FVC).
PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in several in vivo experiments targeting fibrosis, and which has been studied in over 250 patients to date in healthy volunteers and patients with 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 demonstrates our lead drug candidates’ anti-fibrotic activity in several key organs including the kidneys, lungs, liver and the heart.
Plasminogen is a naturally occurring protein that is synthesized by the liver and circulates in the blood. Activated plasminogen, plasmin, is a fundamental component of the fibrinolytic system and is the main enzyme involved in the lysis of blood clots and clearance of extravasated fibrin. Plasminogen is therefore vital in wound healing, cell migration, tissue remodeling, angiogenesis and embryogenesis.
Ryplazim™ (plasminogen) is Prometic’s lead biopharmaceutical product with a submission of the Biologic License Application (BLA), expected to be submitted to the FDA before the end of 2019, seeking approval for the treatment of congenital plasminogen deficiency.
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 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 RyplazimTM (plasminogen) 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 and the United Kingdom.
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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