Sanofi will be the first contributor to the CONQUEST clinical trial platform that has been recently launched to address critical issues in clinical development and enable advances in systemic sclerosis (SSc) research, the Scleroderma Research Foundation (SRF) announced.
“Recent advances in understanding drivers of autoimmunity and fibrosis have generated a rich pipeline of promising therapeutics across autoimmunity and specifically, for scleroderma. However, among other issues, the breadth and depth of opportunities pose clinical development challenges in a rare disease setting such as scleroderma, and CONQUEST arrives at the right moment to address those challenges,” Luke Evnin, PhD, chairman of the Scleroderma Research Foundation said.
“As with all of our research efforts, the incubation and assembly of CONQUEST were underwritten by generous SRF donors. With essential contributions from expert clinicians other as well as our potential pharmaceutical partners, the platform is ready. We are confident that this initiative will pay huge dividends for the global scleroderma community – from patients to clinicians to our pharmaceutical partners.”
The platform will offer many advantages to patients, physicians, and drug innovators in terms of transition to phase 3 global trials, help with examining the medication activity in diverse genetic backgrounds, and fast enrollment of participants. It will include over 130 centers from more than 22 countries.
Read more about SSc experimental therapies
The protocol of CONQUEST provides a regulatory framework to study a number of promising treatments for SSc as well as special benefits that are not common for other platform trials. The CONQUEST Therapy Evaluation Committee will consist of expert SSc clinicians and researchers.
The first iteration of the platform will include 2 innovative SSc therapies, including 1 from Sanofi. The Sanofi drug, previously examined in related diseases in early-stage clinical trials, will be evaluated in approximately 400 patients starting in the last quarter of 2023. The researchers will measure the forced vital capacity at 52 weeks as the primary outcome measure.
Reference
The Scleroderma Research Foundation (SRF) launches Conquest trial platform to address critical issues in clinical development and enable advances in scleroderma therapeutics. News release. Scleroderma Research Foundation; August 1, 2023.
