First-in-class steroid-toxicity outcome assessments licensed by argenx to support development of novel steroid-sparing therapeutics for autoimmune diseases
Boston, MA, USA, 19 November 2024: Steritas LLC., a company dedicated to enhancing care for steroid-treated patients, today announced a licensing agreement with argenx, a global immunology company, for use of its STOX® Suite of steroid-toxicity clinical outcome assessments (COAs) across argenx’s development programs for differentiated immunology therapeutics.
The STOX Suite comprises first-in-class digital instruments that provide a standardized and validated measure of the full scope of steroid-toxicity. The COAs can be applied in research and at the point-of-care to demonstrate the safety and efficacy of new steroid-sparing treatments, and to enable clinicians to optimize treatment, taper steroid usage, and improve patient outcomes.
Under the terms of the multi-year agreement, argenx will incorporate the full STOX Suite as an innovative approach across its Immunology Innovation Program, including in clinical trials, health economics and outcome research, and real-world evidence. The strategic collaboration aims to strengthen the body of research evaluating chronic steroid usage in clinical groups and large populations, and to support development of argenx’s differentiated portfolio of novel antibody-based, medicines for the treatment of autoimmune diseases.
Following the first clinical use of cortisone in 1948, steroids have been used in almost all areas of medicine and are still considered first-line treatment for a wide range of conditions caused by inflammation, despite modern improvements in therapy options. The detrimental impact of long-term steroid use has led to an urgent need to research, monitor and reduce the use of steroids in patients and populations. Recognition of this need led to the development of the Glucocorticoid Toxicity Index (GTI), the first validated COA for quantifying steroid-toxicity, and forming the foundations of Steritas’ STOX Suite.
“Unmasking the damage of long-term steroid use is essential to countering this hidden epidemic – not only when developing new therapies for autoimmune disease, but also for other chronic conditions in which steroids are the standard of care.” commented Martha Stone, CEO at Steritas. She added: “This multi-year agreement with argenx to use the STOX Suite across its entire research program is recognition that steroid-toxicity is a vital area of study, with significance in routine patient care. This bold move by argenx to hold steroids accountable after more than 75 years of overuse will help alleviate patient suffering and healthcare burden.”
“Our pipeline of precision therapeutics is designed to bring relief to patients, both from the burden of the disease they are living with and the burden of existing treatments,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “Collaborating with Steritas to better understand the often profoundly negative impact of long-term steroid use is yet another way that argenx is focusing on the real-world impact our medicines can have for the patients we serve. We are grateful for the partnership with the Steritas team and look forward to deepening the body of evidence in favor of innovative steroid-sparing treatments.”
“Evaluating the burden of steroids in the different conditions we treat is generating important data about the extent of their use and detrimental long-term effects,” said Glenn Phillips, Ph.D., Global Head, VP HEOR, argenx. “Steritas has been a great partner in helping us explore and better understand the measurable negative impact of long-term steroid use and the potential benefit to patients of reducing the burdens associated with steroid-toxicity.”
