PROMETIC RECEIVES FAST TRACK DESIGNATION FOR PBI-4050 IN DEVELOPMENT FOR IDIOPATHIC PULMONARY FIBROSIS (IPF)
- Fast track designation follows recent FDA approval of pivotal Phase 2/3 clinical trial in IPF
' LAVAL, QUEBEC, CANADA – Oct. 25, 2017 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PBI-4050, a clinical candidate in development for idiopathic pulmonary fibrosis (IPF). The Fast Track designation follows the FDA’s recent approval of Prometic’s Investigational New Drug (IND) application and design of the pivotal Phase 2/3 clinical trial in patients with IPF.
“The treatment options for patients with fibrotic diseases like IPF are limited in scope and effectiveness,” said Pierre Laurin, president and chief executive officer of Prometic. “Fast Track designation will allow us to advance PBI-4050 and seek to potentially gain approval in a more efficient process. PBI-4050 has the potential to provide patients with IPF a more effective treatment option. We look forward to demonstrating PBI-4050’s clinical efficacy and strong safety and tolerability profiles in a longer-term, placebo controlled trial.”
The FDA’s Fast Track program is designed to facilitate development and expedite review of drugs, with the main objective of getting important new drugs to patients earlier. Fast Track designation drugs are also eligible for an accelerated approval and priority review, thereby expediting the FDA’s review process. To gain Fast Track designation when there are existing available therapies, a potential new therapy must show an advantage over other currently available treatments, such as showing superior efficacy, an improved side effect profile, decreasing toxicity or ability to address an unmet medical need.
More 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 with IPF die each year, 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 the anti-fibrotic activity of PBI-4050 in several key organs including the kidneys, the heart, the lungs and the liver. It is also effective in improving glucose control in animal models of diabetes. Open label Phase 2 studies in idiopathic pulmonary fibrosis and in Type 2 diabetes have provided preliminary evidence that the results seen in preclinical models translate into the corresponding human diseases.'
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