Reparixin

Published

dm+d

Unassigned

New Medicines

Type 1 diabetes mellitus; prevention of delayed graft function after pancreatic islet transplantation (IAT)

Information

New molecular entity
Dompe farmaceutici
Dompe farmaceutici

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Yes
Yes
Feb 21No longer listed on company pipeline [9].
01. Mar 12: PIII trials to prevent graft dysfunction after islet cell transplantation, allogeneic or autologous, in patients with type 1 diabetes to start soon [1].
02. Granted orphan status in EU Sep 11 [2].
03. Has orphan drug status in the US [3].

Category

Selective inhibitor of chemokine interleukin-8, CXCR1 and CXCR2
10 March 2012Graft rejection in pancreatic islet transplantation affects <0.02 in 10,000 people in the EU, equivalent to fewer than 1,000 people [2]
Type 1 diabetes mellitus; prevention of delayed graft function after pancreatic islet transplantation (IAT)
Intravenous infusion

Trial or other data

01. Oct 12: PIII randomized double-blind multicentre study has started. It will be conducted in Europe and the US in around 60 patients (about half the total number of patients undergoing allogeneic pancreatic islet transplantation worldwide). The study will assess if reparixin improves the efficiency of pancreatic islet transplantation, and if it increases patient insulin independence and blood glucose control [3].
02. Jan 14: PIII NCT01817959 study continues to recruit pts. Data collection for the primary outcome measure (Area Under the Curve for the serum C-peptide level during the first 2 hours of an Mixed Meal Tolerance Test, normalised by the number of Islet Equivalent/kg) is expected to complete in May 14 [4].
03. REP 0211 study = PIII NCT01817959 [4].
04. Mar 14: PIII NCT01967888 study is currently recruiting 100 pts with iatrogenic diabetes in the US. The randomised, double-blind trial will assess whether reparixin improves islet cell transplantation outcomes by measuring the proportion of patients who achieve insulin independence following transplantation. Primary outcome is the proportion of insulin-independent patients following IAT, & data collection is expected to complete by Jan 15 [4].
05. Mar 15: The two PIII studies are on-going and expected to complete in 2016 [5]
06. Jul 15: PIII NCT01967888 study is still recruiting; NCT01817959 has completed recruitment. BOth are still expected to complete collection of primary outcome data by end 2016 [6].
07. Jan 18: NCT01967888 was expected to complete Dec 17 [7].
08. Jan 18: NCT01967888 completed Jan 18, NCT01817959 completed Dec 17 [8].

Evidence based evaluations