TrialSpark Licenses Sprifermin from Merck KGaA, Forms High Line Bio

TrialSpark has formed High Line Bio following the acquisition of worldwide rights to sprifermin from Merck KGaA, Darmstadt, Germany. Sprifermin is a potential first-in-class disease modifying anti-FGF 18 monoclonal antibody that is being evaluated as a potential treatment for osteoarthritis (OA) by promoting cartilage growth. Cartilage loss is an important component in the development of OA, a degenerative joint disease with unmet medical needs. 

As the first monoclonal antibody to demonstrate cartilage growth in a controlled clinical study, Sprifermin is on the forefront of next generation regenerative medicine with the potential to modify the underlying disease pathology in OA. To date, Merck KGaA has completed three clinical trials in over 800 patients, including the 549-patients Phase 2 FORWARD trial.

TrialSpark will be responsible for future development and commercialization of sprifermin. As part of the agreement Merck KGaA will receive an upfront payment as well as equity in High Line Bio, and is eligible for clinical and commercial milestones in addition to royalties. Full financial terms were not disclosed. 

High Line Bio will leverage TrialSpark's tech-enabled clinical trial engine to develop sprifermin in OA using a data-driven approach to identifying novel biomarkers, endpoints, and patient subgroups most likely to benefit from the therapy. TrialSpark is also partnering with industry leaders such as SomaLogic to leverage precision genomics and proteomics platforms to identify key biomarkers and stratify patients using synovial fluid samples from prior clinical studies using AI and machine-learning approaches. Beyond sprifermin, High Line Bio also plans in-license additional complementary products to build a differentiated pipeline focused on OA and regenerative medicine.