CONQUEST has targeted initiation for early 2024 in the US with other countries opening later in the year. The goal is to enroll the entire trial by mid-2025 which would position the trial to have data readout in the 2H 2026.
Scleroderma manifests in patients with many different types of additional physiologic disorders. So, there are other indications for which the platform may be relevant beyond SSc-ILD. We are actively considering additional protocols to address other disease manifestations. Further afield, CONQUEST’s design may also be relevant outside scleroderma, and we are happy to share our learnings outside of our disease community to support other rare disease communities.
Yes, we have worked closely with the FDA with formal pre-IND meetings to assure the trial protocol is acceptable. Their input was a critical piece of the final platform’s development.
As the investigational drugs move through phase 2b, and outcomes data are collected, the Scleroderma Research Foundation (SRF) will work closely with its pharmaceutical partners to disseminate news about the outcome(s) with a given investigational drug. Data sharing is extremely important to us. Beyond the proprietary data, the SRF will own the data from the placebo patients, and we believe these data will be an important component of a growing asset base that has the potential to identify and accelerate novel therapies for scleroderma.
The Scleroderma Research Foundation (SRF) was founded to fund and facilitate the most promising, highest quality research aimed at improved therapies and, ultimately, a cure for scleroderma. We are the country’s first and leading nonprofit investor in medical research into scleroderma.
CONQUEST is a highly innovative platform clinical trial developed by the SRF. The SRF serves as the sponsor of the FDA-approved investigational new drug application (IND).
CONQUEST oversight activities will be managed by an internal team of 5-8 experienced clinical development professionals. This SRF team works closely in partnership with the pharmaceutical companies that have agreed to put their phase 2-ready investigational agents/drugs into CONQUEST. External oversight of CONQUEST is provided by the CONQUEST Steering Committee and the CONQUEST Data Monitoring Committee.
After platform therapies progress to phase 3 clinical trials, what role would SRF play in the next steps to achieve FDA approval?
The SRF would support its pharmaceutical partners’ efforts to present their data from the CONQUEST trial, as requested.
No, this is NOT a revenue generating program per se. However, the SRF does collect a modest overhead charge to offset its internal costs for administrative oversight of CONQUEST and to support the expansion of future trials.
More about CONQUEST.
CONQUEST is designed to rapidly advance promising treatments for scleroderma.
The CONQUEST Steering Committee
Meet the people providing external oversight of CONQUEST.