Early Termination Decision for a Nonviable Treatment Mechanism in Osteoporosis 

The primary challenge was navigating the complexities of osteoporosis treatment and accurately assessing the potential of the novel MOA without conducting extensive clinical trials. Daiichi-Sankyo faced pressure to make timely decisions and avoid unnecessary investment in a nonviable program.

MetrumRG devised a comprehensive strategy, leveraging  bone health expertise and QSP modeling capabilities. A mechanistic, multiscale QSP model was developed to simulate the dynamics of the novel MOA.  The model was built and simulated using the Metworx platform, facilitating efficient computations and analyses.

The QSP model-based approach provided valuable insights, enabling Daiichi-Sankyo to confidently terminate the development of assets focused on the nonviable MOA following a single dose first-in-human trial. Meanwhile, competitors who proceeded with lengthy Phase 2 studies on similar mechanisms encountered failure. 

Identifying and terminating the nonviable MOA early in drug development had significant positive impacts for Daiichi-Sankyo. It led to substantial cost savings (estimated at $25 million) by avoiding further investment in later stage clinical development and allowed the rapid reprioritization of research and development efforts to other programs. Additionally, it saved precious time and demonstrated the value of QSP modeling methods for efficient, accurate, and strategic decision-making.