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Professor Paola Giunti's Friedreich Ataxia trial receives outstanding FDA inspection
6 October 2022
We are delighted to announce that Professor Paola Giunti's trial about Friedreich Ataxia, MOXIe Part II, was FDA inspected in August 2022 at the Leonard Wolfson Experimental Neurology Centre (LWENC) and was assessed as outstanding.
The sponsor REATA Pharmaceuticals filed for marketing authorisation in the US, which prompted a number of site inspections in the US and also at Queen Square. The outcome was outstanding.
Prof Paola Giunti is Professorial Research Associate and Honorary Consultant at UCL/UCLH and is the Investigator for the multicentre MOXie Part II study and MOXIe Extension Study in patients with Friedreich’s ataxia.
Prof Giunti's team for this trial, included Dr Z. Fleszar, Dr G. Black-Thomas, Dr N.Iqbal, is based at Ataxia Centre, UCL Queen Square Institute of Neurology and the National Hospital for Neurology and Neurosurgery UCLH.
Prof P. Giunti
Dr Z. Fleszar
Dr G. Black-Thomas
Prof Paola Giunti : “ I am delighted about the great outcome of the FDA inspection. A trial in a very complex rare disease like Friedreich’s ataxia is never straightforward and I have overcome the challenges of it by setting up the Ataxia Centre at UCL/UCLH that is a robust model for translational research.
The success was due to the great teamwork and communications among us and the excellent team at the LWENC where the study was carried out. I would like to thank C. Gurr, M.Ricamara, M Dhanaratne, M Paz-Alvarez, R.Khengar from LWENC for the preparation for this inspection and Helen Cadiou Head of Quality Assurance in clinical trials at UCL. A special thank you goes to Nikita Parmar Pharmacist for Clinical trial for her performance at the Pharmacy inspection interview session.
I was inspected 10 years ago for another trial in the same disease by the MHRA and again the outcome was outstanding. I am very pleased that with this FDA inspection and the consistency we’ve shown throughout the years delivering high quality data in compliance with GCP."
Prof Anthony Schapira (Professor of Neurological Science, Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology): ‘I am delighted the ataxia trial has been so highly commended by the FDA inspection. The ataxia team, led by Professor Giunti, has once again demonstrated the very high standards of its research work. Such expertise is essential for the success of clinical trials in both common and rare diseases to ensure the results contribute to the advancement of science and the translation of medicines into patient care.’
Prof Michael Hanna (Director of the UCL Queen Square Institute of Neurology) : “ I want to add my warm congratulations to the ataxia and LWENC teams on this achievement. Delivering experimental trials is a key part of the the ION strategic plan as we strive to develop new therapies for patients with rare and common neurological diseases. This important success demonstrates our teams can do this to the required FDA standard and Pharma everywhere should see UCL Queen Square ION as the “go to” centre world-wide for experiential trials. Well done everyone!”
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