Major contract research organization PPD has signed up with study tech firm Clinical Ink to create a new platform for lupus trials.
Under the pact, financials of which have not been shared, the pair has jointly developed a systemic lupus erythematosus (SLE) assessment review process to “simplify operationalizing clinical trials” for this chronic autoimmune disease.
The focus is on boosting data quality along with research site personnel experiences and efficiencies in the hope of allowing its clients to develop new SLE treatments.
There are a number of types of lupus and severities, which can wax and wane, but typically SLE is a long-term condition causing inflammation to the joints, skin and other organs. There's no cure, but symptoms can improve if treatment starts early.
The FDA approved GlaxoSmithKline’s Benlysta for certain lupus patients back in 2011 after a dearth of innovation for the disease. That approval, in fact, marked the arrival of the first new lupus drug in 50 years and the first-ever biologic treatment for the disease. Since then, the drought has returned as companies including Ablynx, Biogen and Xencor have all swung and missed at lupus.
But in the past two years, research has looked a little brighter, with Biogen turning things around with a surprise win for its drug in cutaneous lupus erythematosus last year. AstraZeneca also saw positive data in recent years for its SLE med anifrolumab and a recent regulatory filing.
Its latest lupus pact will see PPD try to help clients do better. This deal will see a customized PPD version of Clinical Ink's so-called electronic Lupus Assessment Suite (eLAS). Using eLAS “simplifies investigator and patient participation in clinical trials and provides pharmaceutical industry customers with near real-time access to SLE endpoint data,” the firm said in a statement.
“Combining PPD’s team of SLE operational and clinical experts with Clinical Ink’s proprietary eLAS solution enables us to offer near real-time access to critical SLE endpoint data,” said Carol Olson, M.D., Ph.D., vice president and head of global product development at PPD.
“This consolidated approach addresses one of the most important challenges in SLE studies related to the variability of placebo response and improves efficacy signal detection. It also enables us to conduct a central review of key data by a dedicated team, enhancing the accuracy and consistency of our results.”
“The assessments used in SLE clinical trials are complex, subject to wide variability and not routinely used in everyday rheumatology clinical practice,” added Doug Pierce, president of Clinical Ink.
“These complexities make operationalizing SLE trials incredibly difficult. By bringing together this custom version of eLAS with PPD’s dedicated expert review team, we are combining efforts to deliver new and enhanced capabilities for customers who are developing new SLE treatment options.”
This is also not PPD’s first lupus-focused pact: Last fall, it inked a deal with Lupus Therapeutics to deepen its biotech clients’ lupus research capabilities. This deal saw PPD give access to protocol and trial optimization capabilities for its customers as well as Lupus Therapeutics' preferred investigators and Lupus Clinical Investigators Network sites.
In turn, Lupus can tap the CRO to provide patients with greater access to novel medicines and clinical care.