Scipher Medicine Announces PrismRA® Met Primary and Secondary Endpoints in Prospective Observational Study Predicting Inadequate Response to World’s Largest-Selling Drug Class

Scipher Medicine, a precision immunology company matching patients with the most effective therapy, today announced positive results from a multicenter, blinded prospective observational clinical study assessing the ability of the PrismRA test to predict which patients with rheumatoid arthritis are unlikely to respond to tumor necrosis factor-alpha inhibitor (TNFi) therapies either when prescribing initial targeted therapy or when modifying treatment. PrismRA is the leading molecular signature test to help guide personalized therapy selection for rheumatoid arthritis.

The study, published in Rheumatology and Therapy, demonstrated that the test consistently predicted non-response to TNFi therapy across two independent cohorts, the CERTAIN cohort, a retrospective analysis, and a multi-center blinded prospective observational clinical study, NETWORK-004, among 391 targeted therapy-naïve and 113 TNFi-exposed patient samples.

The NETWORK-004 study met primary and secondary endpoints, with a molecular signature of non-response detected in 45% of therapy-naïve patients and 40% of patients who have already started TNFi therapy. Patients with the signature of non- response were less likely to have an adequate response to TNFi therapies than those patients lacking the signature according to the standard clinical outcome measure of ACR50 at 6 months (p=0.0001) and additional standard endpoints of low disease activity or remission, including ACR70, CDAI, and DAS28-CRP at 3 and 6 months (p=<0.01). When providers have access to precision medicine at multiple points during care, they can use patient-specific data to improve care, modify treatment, or plan next steps.

“The study shows PrismRA is a robust assay with wide clinical utility that can stratify patients according to their likelihood of responding to therapy,” said Robert Levin, MD, of Bay Area Rheumatology in Clearwater, Florida, immediate past President of the Florida Society of Rheumatology and Affiliate Assistant Professor at the University of South Florida. “This gives providers and physicians much needed patient-specific data to guide therapy and reach their treatment targets sooner at any point in their therapeutic journey.”

“Most rheumatoid arthritis patients are prescribed the world’s largest selling drug class, TNFi therapy, yet the majority will not have an adequate response,” said Alif Saleh, CEO Scipher Medicine. “Evidence-based tools like PrismRA will significantly improve patient outcomes and reduce wasted expense on ineffective medical supplies products by ensuring that patients receive optimal therapy from day one.

“PrismRA helps patients who are suffering from rheumatoid arthritis find a medication that works for them more quickly,” said Sarah White, PA-C, Rheumatology Associates of South Texas in San Antonio,TX. “The wait-and-see approach to therapy selection and inadequate response to therapy are two issues that make caring for rheumatoid arthritis patients difficult. PrismRA introduces precision medicine into a complex disease that hasn’t had tools such as this before.”

About PrismRA®

PrismRA, a molecular signature test, is a revolutionary advancement bringing precision medicine to the treatment of rheumatoid arthritis, which affects 20 million patients globally. From a routine blood draw, the PrismRA test analyzes an individual's molecular signature, helping identify who is unlikely to adequately respond to TNFi therapy, the world’s largest selling drug class, so non-responders can be prescribed alternative effective therapy. Providers now have objective data to guide therapeutic decision-making and give patients the best chance of achieving treatment targets and improving clinical outcomes.

About Scipher Medicine®

Scipher Medicine, a precision immunology company, holds the fundamental belief that patients deserve simple answers to treatment options based on scientifically backed data. Leveraging our proprietary SpectraTM Network Biology platform and artificial intelligence, we commercialize blood tests revealing a persons’ unique molecular disease signature and match such signature to the most effective therapy, ensuring optimal treatment from day one. The unprecedented amount of patient molecular data generated from our tests further drives the discovery and development of novel and more effective therapeutics. We partner with payers, providers, and pharma along the health care value chain to bring precision medicine to autoimmune diseases. Follow Scipher on Twitter, Facebook, and LinkedIn.