Date: 2015-10-29
Type of
information: Clinical trial autorization
phase: 2
Announcement: clinical trial authorization
Company: ProMetic Life Sciences (Canada)
Product: PBI-4050 - 3-pentylbenzenacetic acid sodium salt
Action
mechanism:
- antifibrotic agent. PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in several in vivo experiments targeting fibrosis.
Disease:
Therapeutic
area: Metabolic diseases
Country:
Trial
details:
- This is an open-label, single-arm, Phase II study initially recruiting 20 patients. Each patient will be evaluated against their respective baseline which is very well documented given the severity of their medical conditions. The initial treatment period is 6 months with a possibility to extend the study. The objectives of the study are to evaluate the safety and tolerability of PBI-4050, and the effects of PBI-4050 on key organ function, disease progression and inflammatory/fibrotic markers. (NCT02739217)
Latest
news:
- • On October 29, 2015, ProMetic Life Sciences announced that the clinical trial application for its anti-fibrotic lead drug candidate PBI-4050 in patients suffering from a condition associated with type 2 diabetes and severe multi-organ fibrosis has been cleared by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom. PBI-4050 is currently in a phase II clinical trial in Canada in patients with metabolic syndrome and associated type 2 diabetes. Aside from having already demonstrated safety and tolerability of PBI-4050 in these patients, the Canadian study was also designed to detect early signs of improvement in their metabolic status and to demonstrate that the pharmacological effects observed in preclinical models translate to humans. The Corporation expects to provide preliminary results on the effect of PBI-4050 on metabolic disorders in these patients by year-end.
Is
general: Yes
