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Each year, hundreds of billions of dollars are wasted prescribing drugs of limited clinical benefit to patients, even though often effective alternative therapies are available. The largest contributor to this problem is blockbuster autoimmune disease therapies such as tumor necrosis factor inhibitor (TNFi), the world’s largest selling drug class.

In rheumatoid arthritis alone, 90% of patients are prescribed TNFi drugs as first line targeted therapy yet most patients fail to respond, resulting in 67 cents of every dollar wasted and accelerated patient disease progression, bone erosion, and increased use of opioids to manage symptoms. Put simply, the current treatment pathway for RA and other autoimmune diseases is broken.

Boston-headquartered precision immunology company Scipher Medicine believes there is a better way.

Predictive testing matches patients with effective therapies

 Scipher’s mission is to match autoimmune disease patients with their most effective therapy. Building on more than a decade of research and data, Scipher created a platform that combines the mapping of more than 19,000 proteins in human cells, one of the largest molecular data registries in autoimmune diseases, and unique network science algorithms to create solutions to help patients.

Scipher is bringing precision medicine to patients with autoimmune diseases by commercializing blood tests that reveal a person’s unique molecular disease signature and matching it to the most effective existing therapy. This ensures providers and payers can select optimal therapy from day one. Molecular and clinical data generated from tested patients further fuel the development of targeted, more effective therapeutics through pharma collaborations.

Scipher Medicine’s first product, PrismRA, is a blood test that analyzes the molecular profiles of patients with rheumatoid arthritis to identify those unlikely to respond to TNFi therapy. Study data recently published in Expert Review of Molecular Diagnostics showed that patients who were prescribed a treatment guided by their PrismRA results had a significantly improved clinical response rate of more than three times.

“The ability to predict non-response to TNFi therapy is clinically very valuable,” said Sam Asgarian, M.D., MBA, chief medical officer at Scipher. “PrismRA allows patients to potentially bypass a very costly drug class with an exceptionally low response rate, something that’s been troubling the rheumatology community for decades. Integrating PrismRA testing into the care pathway for patients with RA improves clinical outcomes while decreasing pharmacy and medical costs.”

Nearly 15 percent of American rheumatologists are using PrismRA, and Scipher has already partnered with more than 20 healthcare companies to enhance private payor coverage for the blood test. Beyond rheumatoid arthritis, Scipher is developing similar tests for ulcerative colitis, Crohn’s disease, and multiple sclerosis, all intended to optimize therapy selection in patients with these autoimmune conditions. Scipher plans to launch at least one new test a year for the next five years.

“A blood test capable of predicting patient responses to a commonly prescribed class of rheumatoid arthritis therapies could fundamentally shift the treatment paradigm,” said study co-author Vibeke Strand, M.D., adjunct clinical professor, Division of Immunology and Rheumatology, Stanford University School of Medicine. “Broad adoption of this important advancement could result in significant improvements in treatment outcomes.”

The next frontier: Using data to develop new drug therapies for autoimmune diseases

The data supporting the PrismRA tests and generated from their use have utility beyond helping guide treatment. Scipher uses similar molecular profiling to help better understand underlying disease biology, and in turn, develop new drug therapies. Scipher is working with pharma partners to discover, develop, and bring to market new and more effective therapeutics that target diseases with low drug response rates.

Scipher’s first pharma partner is Galapagos NV, and they are exploring several therapeutic targets in ulcerative colitis. With GNS Healthcare, Scipher is using a proprietary artificial intelligence platform to test medications in so-called in silico rheumatoid arthritis patients, or computer models of patients with the disorder. And with TARA Biosystems, Scipher hopes to identify treatment targets in cardiac laminopathy, a heart condition caused by a single gene mutation that currently has no cure.

“We expect to extend use our platform to other disease areas in the future,” said Alif Saleh, chief executive officer of Scipher Medicine. “We are working urgently to enable access to PrismRA and the tests that follow, and to establish partnerships with leading pharmaceutical companies, to help more people.”

Others also are bullish about Scipher’s prospects to solve one of healthcare’s biggest challenges.

“Precision medicine has transformed oncology in ways we could only imagine a decade ago. The next frontier to tackle is autoimmune diseases where very few if any solutions exist today,” said Tim Anderson, partner and head of Research at Cowen Healthcare Investments, a powerhouse investor that led Scipher’s most recent financing round. “Scipher is uniquely positioned to lead this field with the company’s data platform, products, team, and business model.”

Learn more about Scipher Medicine.