A virtual start-up biotech company acquired an immunomodulatory mechanism from a large pharmaceutical firm. This compound, targeted at inflammatory pathways for a primary care indication, had already undergone phase 1 evaluation and several small, exploratory phase 2a pilot studies.

With a growing urgency to advance development while managing limited resources, the client initially proposed two separate studies:

• One to evaluate a series of loading doses and validate a composite endpoint 
• Another to assess the compound’s broader clinical utility 

This dual-study approach posed challenges in terms of complexity, timeline and budget. The client turned to ICON to help streamline development. 

ICON’s drug development experts undertook a comprehensive review of the existing biological, PK/PD, C50 and bioavailability data. Using advanced modelling and simulation tools the team assessed the clinical hypothesis and identified opportunities to simplify the development path. 

Rather than progressing with two separate trials, ICON proposed a novel unified study design. The single trial integrated the critical objectives of the original two studies, while eliminating the need for loading doses. This streamlined approach allowed for: 

• A more efficient path to feasibility and study start-up
• Reduced trial complexity and cost
• Accelerated decision-making and execution timelines

ICON’s team took the lead on developing the protocol synopsis and full clinical trial protocol. The new design was not only approved by the client, but also validated by the orginator company and endorsed by a globally recognised key opinion leader in the field.

By partnering with ICON, the biotech sponsor successfully optimised its clinical trial protocol, enabling a faster, more cost-effective path forward. The streamlined approach reduced the anticipated burden and yielded an estimated $30 million in development cost savings, an extraordinary impact for an early-stage company operating in a competitive and resource-constrained environment.