FDA confirms Prometic's PBI-4050 IPF clinical trial design
FDA concurs with add-on placebo controlled phase 2/3 clinical trial for PBI-4050 in combination with nintedanibPrometic to also conduct placebo controlled phase 2/3 PBI-4050 Monotherapy clinical trial____________________________________________________________
' LAVAL, QC, April 18, 2017 /PRNewswire/ - Prometic Life Sciences Inc. ( TSX: PLI) ( OTCQX: PFSCF) ("Prometic" or the "Corporation") announced today that it has received concurrence from the US Food and Drug Administration ("FDA") on the design of the first of its PBI-4050's planned phase 2/3 clinical trials for IPF based on the efficacy data generated in the recently completed 40 patient Phase 2 open-label study.
In that phase 2 study, PBI-4050 was given for 12 weeks to patients who were receiving pirfenidone, nintedanib, or neither agent. The results of the study showed that the Forced Vital Capacity (FVC) remained stable in patients on PBI-4050 alone (n=9, FVC -12 ml) or in patients on PBI-4050 in combination with nintedanib (n=15, FVC +2 ml). In contrast, the results of said study showed that the FVC declined significantly in patients on PBI-4050 in combination with pirfenidone (n=16, FVC -105 ml). PBI-4050's plasma concentration was sub-therapeutic at 50% of the expected level in patients that received the PBI-4050 and pirfenidone combination, suggesting a drug-drug interaction.
Dr. John Moran, Chief Medical Officer of Prometic commented: "This early evidence of efficacy observed with PBI-4050 alone or in combination with nintedanib points toward very promising treatment options that will be further tested in two separate phase 2/3 clinical trials. We are very pleased that the FDA concurs with our decision to exclude a combined pirfenidone and PBI-4050 treatment arm in the upcoming phase 2/3 add-on study".
The design for the add-on placebo-controlled phase 2/3 pivotal trial will therefore be an amended version of the protocol the FDA originally requested during the pre-IND meeting: IPF patients currently treated with nintedanib would be randomized to receive in addition either PBI-4050 or a placebo.
Prometic also intends to initiate a second phase 2/3 placebo-controlled trial which would enroll IPF patients who have failed to tolerate nintedanib or pirfenidone and would be randomized to receive either PBI-4050 or placebo, ("PBI-4050 Monotherapy").
"To date, PBI-4050 has presented a remarkable safety and tolerability profile throughout all clinical trials", said Mr. Pierre Laurin, President and Chief Executive Officer of Prometic. "We are also very pleased that our phase 2 open label study in IPF patients has served the very important strategic purpose of allowing us to optimize the design of our pivotal clinical program for this devastating medical condition".
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 subjects 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 subjects in the U.S. alone are believed to suffer from chronic kidney diseases ("CKD"). Subjects 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 subjects.'
Jim |
