- No serious adverse events in CKD patients
- PBI-4050 clinical programs to expand to novel indications in the USA and EU.
- Enrolment of patients in PBI-4050 metabolic syndrome and type 2 diabetes Phase II trial to begin in April 2015
LAVAL, QUEBEC, CANADA, – March 19, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(“ProMetic” or the “Corporation”) reported today that it has successfully completed its PBI-4050 Phase Ib multi-dose clinical trial in patients with chronic kidney disease. ProMetic’s orally active lead drug candidate, PBI-4050, was found to be safe and well tolerated without any serious adverse events reported.
The objectives of this, randomized, double-blind, placebo-controlled, multi-dose study were to demonstrate the safety and tolerability of PBI-4050 and to determine the pharmacokinetic profile of PBI-4050 following multiple oral doses over 10 days in patients with stage 3b or 4 stable renal impairment. The trial was conducted in 8 patients with 6 patients receiving PBI-4050 and 2 patients receiving matching placebo.
“We are pleased to see that the safety and pharmacokinetic profiles of our lead drug candidate remain unaffected by the severely impaired renal function in the patients tested”, commented Dr. John Moran, ProMetic’s Chief Medical Officer. “Since fibrosis is the pathological pathway leading to organ failure and death in many diseases of differing aetiologies and affecting various organs, we plan to test the efficacy of this drug in several of fibrosis-related conditions”
The Phase II clinical trial in patients suffering from the metabolic syndrome and the resulting Type 2 diabetes is scheduled for patient enrolment to commence in April, 2015 following the recent CTA clearance by Health Canada. PBI-4050 has also received an orphan drug designation status by the FDA for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”) and a phase II trial in IPF has been cleared by Health Canada and is scheduled to commence in the coming weeks.
Both phase II trials are 12 weeks, open-label, single-arm, exploratory Phase II studies to evaluate the safety and tolerability of PBI-4050 in 40 patients suffering from IPF and 12 to 36 patients suffering from the metabolic syndrome and the resulting type 2 diabetes. Both Phase II trials will gather data on the effects of PBI-4050 and will monitor each patient’s progress against their own respective baseline.
Following the confirmation of PBI-4050’s safety profile in both healthy volunteers and patients, the Corporation is expanding its clinical programs in both the US and EU in existing indications and in rare disease indications associated with fibrosis.
More on PBI-4050
PBI-4050 is an orally active lead drug candidate with excellent efficacy and safety 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 gradually 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, the heart, the lungs and the liver. Twenty six million patients in the U.S. alone are diagnosed with chronic kidney diseases (“CKD”). Patients with severe CKD stages (3 and 4) suffer from a gradual and accelerated loss of their renal function (end stage renal disease or ESRD) leading to the need for maintenance dialysis or kidney transplant.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. ProMetic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. ProMetic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies. Headquartered in Laval (Canada), ProMetic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and business development activities in the U.S., 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, 2013, 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.