TrialSpark licenses sprifermin, an investigational first-in-class disease modifying treatment for osteoarthritis, from Merck KGaA, Darmstadt, Germany and announces formation of High Line Bio

-High Line Bio will focus on addressing osteoarthritis, a disease affecting more than 230 million patients worldwide and with no disease modifying therapies

-High Line Bio will leverage TrialSpark's unique ability to develop treatments faster and more efficiently for patients than traditional pharma companies through its proprietary technology-enabled clinical trial engine

-TrialSpark is continuing to rapidly advance its strategy of acquiring, in-licensing, and investing in clinical-stage assets to develop in-house or in partnership with biotech and pharma companies

NEW YORK, NY, USA I January 10, 2022 I TrialSpark announced today the formation of 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 recombinant form of human fibroblast growth factor 18 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 which is one of the biggest unmet medical needs among musculoskeletal conditions.  There are no approved disease modifying therapies for OA which is a major cause of disability and impaired quality of life affecting more than 230 million patients globally.

As the first recombinant form of human fibroblast growth factor 18 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, Darmstadt, Germany has completed three clinical trials in over 800 patients, including the 549-patients Phase 2 FORWARD trial. TrialSpark will be fully responsible for future development and commercialization of sprifermin. As part of the agreement Merck KGaA, Darmstadt, Germany will receive an upfront payment as well as equity in High Line Bio, and is eligible for clinical and commercial milestone payments in addition to royalties on future net sales. Full financial terms were not disclosed.

Sprifermin promotes cartilage growth, and could be a potential disease modifying treatment for osteoarthritis.

"We believe sprifermin has the potential to be the first disease modifying therapy approved for the millions of patients suffering from OA," said Gavin Corcoran, Chief Medical Officer at TrialSpark. "Despite recent advances in our understanding of the pathogenesis of OA, clinical development has remained behind other rheumatic diseases. TrialSpark's proprietary clinical trial engine is uniquely positioned to address historical challenges in OA development including long studies requiring many patients, designing optimal pain endpoints, and identifying key patient subgroups most likely to benefit."

TrialSpark's ability to leverage its tech-enabled trial engine to run faster and more efficient drug development enables it to pursue programs in indications - such as OA - that have historically required the longest, most expensive clinical trials. High Line Bio will leverage TrialSpark's proprietary 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.

This transaction is in line with TrialSpark's strategy of creating new companies across key therapeutic areas like inflammatory and autoimmune disease. To date, TrialSpark has successfully in-licensed multiple assets, deploying capital and supporting programs across a broad range of therapeutic areas including CNS, dermatology, and inflammation as part of its mission to bring new treatments to patients faster and more efficiently.

As part of its business development and investments strategy, TrialSpark is using balance sheet capital to acquire or license assets, leveraging its in-house clinical development engine to run trials significantly faster and more efficiently than industry. In addition to conventional asset licensing and acquisition, TrialSpark transactions can also include equity investments in both private and public biopharma companies, strategic collaborations to jointly fund and develop assets, and alternative structures including syndication with other investors.

TrialSpark is actively pursuing partnerships with both small biotech and larger pharma companies through flexible and creative collaboration structures, maximizing the potential value of drug candidates for all stakeholders through faster and more efficient clinical development programs. TrialSpark is focused on early to mid-stage clinical assets across a range of therapeutic areas, with a focus on chronic diseases that are treated outside of a hospital setting.

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck KGaA, Darmstadt, Germany, generated sales of €17.5 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

About TrialSpark
TrialSpark is a technology-driven pharma company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently. TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality. TrialSpark in-licenses and co-develops drug programs through in-house development, joint ventures, and NewCos. TrialSpark is backed by leading investors such as Sam Altman, Lachy Groom, Michael Moritz, Casdin Capital, Sequoia Capital, Thrive Capital, Dragoneer, Section 32, John Doerr, Spark Capital, Felicis Ventures, Sound Ventures, Arrowmark, and previous investors.

SOURCE: TrialSpark

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