Prioritizing the pipeline for success
Lilly’s initial engagement with Lupus Therapeutics included convening a scientific advisory board of expert key opinion leaders to evaluate the company’s drug development pipeline of potential lupus drug candidates. Lupus Therapeutics’ advisors vetted and assisted Lilly with a prioritized list of candidates, along with a detailed overview of specific populations of patients among which to evaluate the therapeutic candidates. This initial engagement not only helped to focus on the most promising candidates, but engaged and excited the lupus thought-leader community on the potential for Lilly’s pipeline.
Designing patient-centric human trials
Once the candidates were prioritized and agreed on with Lilly senior leadership, Lupus Therapeutics collaborated with the company to design a Phase 2 clinical trial protocol that was both scientifically sound and patient centric. Lupus Therapeutics supported Lilly in obtaining FDA feedback and approval on this protocol.
Identifying clinical trial sites at an accelerated pace
Once FDA approved the trial protocol, Lilly tapped Lupus Therapeutics to identify, prioritize and engage academic sites from within LuCIN that would best position the company for a rapid trial start up. Despite the active COVID-19 pandemic, within 30 days, Lupus Therapeutics secured interest and formerly conducted feasibility from 35 academic sites within LuCIN. This led to the rapid prioritization and identification of sites to engage.
Holding investigators and sites accountable for success
Additionally, Lupus Therapeutics put in place protocols to ensure sites are performing to the level of agreement and are responsible for holding each site and investigator accountable to trial success. Lilly is actively working with Lupus Therapeutics to recruit and engage patients in the Phase 2 study.