Positive outcomes of Scipher’s retrospective trial was the first step of a two-step clinical development project to validate Scipher’s test – Prism.
Prism is a proprietary blood test to predict non-response to anti-tumor necrosis factor (anti-TNF) therapies, including Humira (adalimumab), Enbrel (etanercept), and Remicade (infliximab). While anti-TNF therapies are one of the largest selling drug classes in the world, a majority of patients prescribed to the therapy, according to Scipher, do not reach treatment targets.
Alif Saleh, CEO of Scipher Medicine, told us that patients not reaching target treatments face two major strains: financial and clinical. He used Humira as an example stating that it sells for $20bn (€17.4bn) a year, but 65% of patients prescribed the drug do not respond to it.
“If we can avoid that [there] would be a financial gain, [patients] will save a lot of money,” Saleh said.
Scipher’s platform uses RNA data from a patient’s blood sample to find patients’ ‘disease signature.’ The test, Saleh said, “identifies what proteins are at play in your particular disease and then we can decide if there’s a drug that actually targets those proteins. A lot of times [patients] are given drugs that don’t really target what their disease is.”
The second strain, a clinical strain, is a lack of patient response to the drug. “Your [patients] are not getting better, your [patients] disease progresses,” he explained. Scipher’s Prism test assesses whether a patient will or won’t respond to a drug, and find alternative therapies to try.
‘Double the response rate’
Using the test Scipher discovered, “Our response rate to the top ten selling drugs in the world is 10%. [That means] 90% of patients that are prescribed one of the top-selling drugs don’t respond to the therapy.”
From this Saleh explained that Scipher also has the ability to create drugs for individual patients or individual patient groups by using RNA data providing clinical utility or making sure patients get the right therapy from day one.
Saleh said that Scipher’s data sets showed that the test could provide improved clinical utility across the board, “Our data states that with this test we will double the response rate, so twice the amount of patients will respond to therapy with our test, compared to without it.”
Since the test is disease agnostic, it can be applied to different disease states for multiple clinical applications.
Scipher will launch a prospective interventional randomized trial in 2019 in the United States to validate Prism’s clinical utility in rheumatoid arthritis.
