MedicalResearch.com Interview with:
Pierre Laurin, CEO
Prometic Life Sciences
MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by idiopathic pulmonary fibrosis?
Response: 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). The 5-year mortality rate for patients with IPF is estimated to range from 50% to 70%.
Small molecule candidate PBI-4050’s anti-fibrotic activity has been observed in various fibrosis models in different organs: lung, kidney, heart, liver, and pancreas. PBI-4050 has been shown to improve forced vital capacity (FVC) in an open-label Phase 2 study in IPF.
The main objective of this exploratory study was to determine whether treatment with PBI-4050 alters the level of key biomarkers in patients with IPF. Subjects with a confirmed diagnosis of IPF received daily oral doses of 800 mg PBI-4050 with or without nintedanib or pirfenidone for 12 weeks. The biomarkers chosen for measurement can be divided into two main groups: cytokines and matrix metalloproteinases associated with fibrosis and inflammation.
MedicalResearch.com: What are the main findings?
Response: The Phase 2 study has demonstrated that PBI-4050 is safe and very well tolerated, which is always an objective in any clinical study and is of particular interest for IPF patients given that the current treatment options are not very well tolerated. On top of that, the study has demonstrated positive clinical activity not seen with other treatment options before.
A total of 40 subjects were enrolled in the study conducted in 6 sites across Canada and completed the 12 weeks of treatment.
In the Prometic clinical study, the respiratory function of the subjects, measured as the forced vital capacity (FVC (ml)), remained stable after 12 weeks of treatment with PBI-4050 alone and in combination with Ofev® (Boehringer-Ingelheim drug). This is an exceptional performance given that IPF patients whether or not on currently approved IPF drugs will see their respiratory function decline every month/quarter.
MedicalResearch.com: What should readers take away from your report?
Response: PBI-4050 alone or in combination with nintedanib demonstrated promising efficacy. The results from the exploratory biomarkers analysis suggest the potential of PBI-4050 as an anti-fibrotic, anti-inflammatory and pro-tissue repair candidate.
We now have a clear understanding of the unique mechanism of action of PBI-4050 and are very confident in its potential to help patients suffering from fibrosis-related conditions such as IPF and Alström Syndrome.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Serious medical conditions representing large unmet medical needs like IPF will eventually progress to be treated as chronic conditions rather than terminal illnesses. To achieve that though, the industry will need to be creative and demonstrate a multi-level and approach philosophy. The so-called “smart bomb” approach where you target only a very precise clinical target, although appealing from a clinical and corporate point of view, is rarely sufficient to treat complex clinical indications such as IPF. One should always look at combining different approaches to maximize the chances of success.
MedicalResearch.com: Is there anything else you would like to add?
Response: Prometic now will undertake an “all comers” Phase 3 study of PBI-4050 in IPF. The enrollment criteria will be greatly simplified such that the study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV®) or not. Therefore, the study will provide efficacy data on both PBI-4050 as a stand-alone agent, and as an add-on to nintedanib, and will be part of the dataset to support a simple, all-inclusive indication “for the treatment of IPF.”
Keep an eye on our research and clinical studies as we are now entering pivotal clinical phases where we could end up demonstrating having found the solution to one of the biggest medical problem, fibrosis.
ATS abstract discussing PBI-4050 stabilized lung function for patients with idiopathic pulmonary fibrosis and demonstrated an anti-fibrotic, anti-inflammatory and pro-tissue repair mechanism.
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