- Early evidence of efficacy of PBI-4050 alone and also in combination with one of the commercially available IPF drugs
- PBI-4050 shown to be very well tolerated whether used alone or in combination with nintedanib or pirfenidone
LAVAL, QUEBEC, CANADA, – November 17, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)(“ProMetic” or the “Corporation”) announced today positive interim results from its Open Label Phase 2 clinical trial in patients suffering from idiopathic pulmonary fibrosis (“IPF”). In addition to demonstrating that PBI-4050 is safe and well tolerated in patients suffering from IPF, the objective of this study was to provide early evidence of clinical benefits of PBI-4050 treatment whether used alone or in addition to either nintedanib or pirfenidone. Forty patients are enrolled in the study in 6 sites across Canada. At this time, the Corporation is reporting on the first 30 patients that have completed their 12 weeks of treatment.
“We are very pleased with the results to date from this study as they provide us with very important data points relating to efficacy and safety” stated Dr. John Moran, Chief Medical Officer of ProMetic. “There is early evidence of efficacy in the patients treated with PBI-4050 alone and in those treated with PBI-4050 in combination with one of the commercially available drugs. This compares favourably to that of the pirfenidone or nintedanib treatment reported in the ASCEND trial and in the two INPULSIS trials, respectively. Further good news is the fact that PBI-4050 is very well tolerated by IPF patients whether used alone or in combination with either nintedanib or pirfenidone” added Dr. Moran.
The comparisons made hereunder between the results in this ProMetic study and the results of three other larger phase 3 studies undertaken by third parties (ie .ASCEND, INPULSIS-1 and INPULSIS-2) are only done to provide some guidance in terms of the potential clinical benefits of PBI-4050 for IPF patients. In the ASCEND and the two INPULSIS studies, IPF patients being treated with pirfenidone or nintedanib saw their Forced Vital Capacity (“FVC”) decline by approximately -25 ml to -30 ml after 13 weeks of treatment, whilst the FVC of those on placebo declined by -75 ml to -100 ml during the same period.
IPF patients in ProMetic’s ongoing clinical trial receiving PBI-4050 alone or PBI-4050 with one of the commercially available drugs for 12 weeks have actually seen a slight improvement in their FVC (~ +10 ml).
Moreover, to date, none of the patients receiving PBI-4050 experienced a decline of ≥ 10% in FVC or death during the 12 weeks of treatment. In the phase 3 clinical trial ASCEND the authors reported that 7.5% of patients had a ≥10% decline in FVC or death after 13 weeks of treatment (5% on placebo and 2.5% on pirfenidone treatment).
“As mentioned above, we use the information generated in these three large trials to help us benchmark PBI-4050’s performance whether used alone or in combination with the commercial agents”, explained Dr. Joe Parker Senior Director, Clinical Development at ProMetic. “IPF is a terrible condition where patients’ lung function keeps declining even when treated by pirfenidone or nintedanib. Our preliminary results are quite encouraging and will help us define the next steps for our promising lead drug candidate PBI-4050” concluded Dr Parker.
More data will be discussed during the Corporation’s forthcoming analyst day on November 21 in NYC.
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. IPF affects about 130,000 people in the United States, with about 48,000 new cases diagnosed annually. Approximately 40,000 people die each year with IPF, a similar number of deaths to those due to breast cancer. The 5-year mortality rate for patients with IPF is estimated to range from 50% to 70%.
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, the heart, the lungs and the liver. Twenty six million patients in the U.S. alone are believed to suffer from chronic kidney diseases (“CKD”). Patients with severe CKD stages (3 and 4) suffer from a progressive loss of their renal function leading to end-stage renal disease and the need for dialysis or kidney transplant. Cardiovascular complications are the most common cause of death in dialysis patients.
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 commercial activities in the U.S., Canada, Europe, Russia, Asia and Australia.
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, 2015, 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.