LAVAL, QUEBEC--(Marketwired - Oct. 1, 2015) - ProMetic Life Sciences Inc. (TSX:PLI)(OTCQX:PFSCF), ("ProMetic" or the "Corporation") announced today it had a successful Pre-Investigational New Drug ("Pre-IND") meeting with the US Food and Drug Administration ("FDA") for its orally active anti-fibrotic lead drug candidate, PBI-4050.
The meeting with the FDA focused on ProMetic's proposed clinical development program for PBI-4050 in patients with IPF, and particularly on an optimal design for the first pivotal clinical trial that will incorporate the current standards of care for IPF in the US. The two drugs commercially available to treat IPF have been shown in clinical trials to slow the progression of the disease, but not to reverse it. Treatment of this devastating condition therefore remains an urgent medical need, and IPF patients could potentially benefit from PBI-4050, either alone or in combination with current therapies. It is notable that in the gold standard preclinical model used to emulate pulmonary fibrosis in humans, PBI-4050 performed favorably compared to these recently approved drugs, and demonstrated synergistic effects when combined with pirfenidone (Esbriet®).
"The outcome of this meeting is that ProMetic will proceed with a placebo-controlled pivotal study in the USA in order to evaluate the combination of PBI-4050 with nintedanib or pirfenidone", commented Dr. John Moran, ProMetic's Chief Medical Officer. "This is an important milestone as it allows us to move forward with this multi-center study sooner than anticipated, and with a clear regulatory path".
The multi-center pivotal study will be a double-blind, placebo-controlled design with IPF patients on pirfenidone or nintedanib randomized to receive either PBI-4050 or a placebo. The study will be powered to demonstrate a statistically significant difference in forced vital capacity ("FVC") changes between the PBI-4050 combination therapies and the current standards of care. The design of the definitive protocol is currently being completed by consultants expert in this field, and ProMetic expects to file its IND with the FDA during the first quarter of 2016.
"To date, PBI-4050 has presented a remarkable safety and tolerability profile throughout our phase I trials and ongoing phase II clinical trial", said Mr. Pierre Laurin, CEO of ProMetic. "The objective of this pivotal trial is to demonstrate that PBI-4050 can safely provide significant additional clinical benefits to IPF patients and we appreciate the input of the FDA regarding the design of the trial".
About Idiopathic Pulmonary Fibrosis ("IPF")
Idiopathic pulmonary fibrosis (IPF) is a chronic, devastating, and ultimately fatal disease characterized by a progressive decline in lung function. It is a specific type of interstitial lung disease in which the small air sacs of the lung, the "alveoli," gradually become replaced by fibrotic (scar) tissue and is the cause of worsening dyspnea (shortness of breath). IPF is usually associated with a poor prognosis. The term 'idiopathic' is used because the cause of pulmonary fibrosis is still unknown. IPF usually occurs in adult individuals of between 50 and 70 years of age, particularly those with a history of cigarette smoking, and affects men more often than women.
More on 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, 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 hemodialysis. Cardiovascular complications for ESRD patients on hemodialysis are a common cause of death.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (www.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, 2014, 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.