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

-High Line Bio will focus on the treatment of osteoarthritis, a disease affecting over 230 million patients worldwide and without disease-modifying therapy

-High Line Bio will leverage TrialSpark’s unique ability to develop treatments faster and more efficiently for patients than traditional pharmaceutical companies through its proprietary technology-based clinical trials engine

-TrialSpark continues to rapidly advance its strategy of acquiring, licensing and investing in clinical-stage assets to be developed in-house or in partnership with biotechnology and pharmaceutical companies

NEW YORK, January 10, 2022 / PRNewswire / – TrialSpark today announced the formation of High Line Bio following the acquisition of the worldwide rights to sprifermine from Merck KGaA, Darmstadt, Germany. Sprifermin is a leading potential disease-modifying anti-FGF 18 monoclonal antibody that is being evaluated as a potential treatment for osteoarthritis (OA) by promoting cartilage growth. The loss of cartilage is an important component in the development of osteoarthritis, a degenerative disease of the joints that is one of the greatest unmet medical needs among musculoskeletal disorders. There are no approved disease-modifying therapies for osteoarthritis, which is a leading cause of disability and impaired quality of life affecting more than 230 million patients worldwide.

(PRNewsfoto / TrialSpark)

Sprifermin promotes the growth of cartilage and could be a potential disease modification treatment for osteoarthritis.

As the first monoclonal antibody to demonstrate cartilage growth in a controlled clinical study, Sprifermin is at the forefront of next-generation regenerative medicine with the potential to modify the underlying pathology of osteoarthritis. To date, Merck KGaA, Darmstadt, Germany completed three clinical trials in more than 800 patients, including 549 patients FORWARD Phase 2 Trial. TrialSpark will be fully responsible for the future development and commercialization of sprifermin. As part of the Merck KGaA, Darmstadt agreement, Germany will receive an upfront payment as well as an interest 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.

“We believe that sprifermin has the potential to be the first approved disease-modifying therapy for the millions of patients with osteoarthritis,” said Gavin Corcoran, chief medical officer at TrialSpark. “Despite recent advances in our understanding of the pathogenesis of osteoarthritis, clinical development has lagged behind other rheumatic diseases. TrialSpark’s proprietary clinical trial engine is uniquely positioned to address the historic challenges of osteoarthritis development, including lengthy studies requiring large numbers of patients, designing optimal pain parameters, and identifying key subgroups of patients most likely to benefit from it. “

TrialSpark’s ability to leverage its technology-based testing engine to execute faster and more efficient drug development allows it to pursue programs in indications – such as osteoarthritis – that have historically demanded testing. longest and most expensive clinics. High Organic line will leverage TrialSpark’s proprietary clinical trial engine to develop sprifermin in osteoarthritis using a data-driven approach to identify novel biomarkers, endpoints and patient subgroups most likely to benefit from 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 fluid samples. synovial membrane from previous clinical studies using AI and machine learning approaches. Beyond sprifermin, High Line Bio is also planning complementary licensed products to build a differentiated pipeline focused on osteoarthritis and regenerative medicine.

This transaction is part of TrialSpark’s strategy to create new companies in key therapeutic areas such as inflammatory and autoimmune diseases. To date, TrialSpark has successfully licensed multiple assets, deploying capital and supporting programs across a wide range of therapeutic areas including CNS, Dermatology and Inflammation as part of its mission to bring new treatments to patients faster and more effectively.

As part of its business development and investment strategy, TrialSpark uses balance sheet capital to acquire or license assets, leveraging its in-house clinical development engine to conduct trials much faster and more efficiently than the industry. . In addition to traditional asset licenses and acquisitions, TrialSpark transactions may also include equity investments in private and public biopharmaceutical companies, strategic collaborations to jointly finance and develop assets, and alternative structures, including syndication with other investors.

TrialSpark actively pursues partnerships with small biotech companies and large pharmaceutical companies through flexible and creative collaborative structures, maximizing the potential value of drug candidates for all stakeholders through faster and more clinical development programs. effective. TrialSpark focuses 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 company in the field of science and technology, operates in the fields of health, life sciences and electronics. Approximately 58,000 employees work every day to make a positive difference in the lives of millions of people by creating happier and more sustainable lifestyles. From advancing gene-editing technologies and discovering unique ways to treat the most difficult diseases, to device intelligence, the business is everywhere. In 2020, Merck KGaA, Darmstadt, Germany, achieved a turnover of 17.5 billion euros in 66 countries.

The company owns the worldwide rights to the name and trademark “Merck” internationally. The only exceptions are United States and Canada, where the business areas of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life sciences, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been at the heart of the company’s technological and scientific advances. To this day, the founding family remains the majority shareholder of the listed company.

About TrialSpark
TrialSpark is a technology-driven pharmaceutical company that conducts end-to-end clinical trials focused on delivering 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 better quality of trial data. TrialSpark licenses and co-develops drug programs through internal development, joint ventures and NewCos. TrialSpark is backed by leading investors such as Sam altman, Married Lachy, Michel moritz, Casdin Capital, Sequoia Capital, Thrive Capital, Dragoneer, Section 32, John doerr, Spark Capital, Felicis Ventures, Sound Ventures, Arrowmark and former investors.

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