People with Parkinson’s disease (PwPD) have limited options to manage their disease. There are currently no disease-modifying therapies to halt or reverse progression and the therapeutics that make up the backbone of Parkinson’s symptom management can lead to difficult side effects; determining the right dose on a patient-by-patient basis can take months of back and forth with a clinician. At Rune Labs, we are dedicated to improving the lives of PwPD by using objective data to guide patients and clinicians to make informed care decisions – and today, we launched a new platform, called StriveStudy, to bring our precision neurology approach into drug development.
Historically, clinical trials evaluating new therapies for Parkinson’s have been held back by the very nature of the disease. Parkinson’s is very heterogeneous – PwPD progress at rapidly different rates and have a unique array of symptoms that fluctuate over the course of a day. That makes it difficult to enroll the right patients for a clinical trial; even with well thought out inclusion criteria, trials end up including PwPD who differ on important dimensions. Imagine running a trial that includes people whose natural rate of progression is two to three times that of others. This can make it difficult for researchers to effectively evaluate whether or not a drug is helping.
Clinical trials also rely on subjective patient-reported questionnaires as endpoints because there are no real biomarkers of disease progression. These assessments miss both the dynamic nature of the disease and are likely not sensitive enough to capture changes during the early stages targeted in most drug trials.
PwPD may also have difficulty complying with certain clinical trial protocols, as some require patients to be “off-meds” during the study.
To overcome these barriers that have stymied progress in Parkinson’s, we developed StriveStudy as a vital tool for biopharmaceutical companies creating the next generation of treatments.
By applying the same data-driven ideas that powered the precision oncology movement, StriveStudy is a wrap-around clinical trial platform supporting data collection and enriched recruitment in clinical trials. Our technology captures multi-modal longitudinal symptom data, including continuous collection tremor and dyskinesia symptoms, validated via FDA 510(k) last year. StriveStudy also tracks heart rate variability, sleep patterns, and other HealthKit measures, as well as conducts patient surveys via the Apple Watch. The platform collates clinical data, medical records, imaging, PRO and other data relevant to characterize a patient’s disease profile. This data can be valuable in understanding treatment effects at baseline, on-trial and in the follow-up setting.
Our Apple Watch-based app enables real-time patient monitoring; with StriveStudy, trial sponsors can track enrollment and compliance. The platform can also boost compliance by leveraging user-friendly technology and providing access to a team of participant support specialists who are there to answer any questions and alleviate any fears participants may have about using technology.
Additionally, drug developers can access our expansive nationwide clinical network and patient database to recruit individuals with specific disease profiles based on years of longitudinally collected data. When patients in a study are more likely to progress at similar rates, it’s easier to detect a therapeutic benefit.
StriveStudy addresses many of the issues that researchers and drug developers have faced in clinical trials of movement disorders. By more holistically and objectively capturing disease activity, drug developers will be able to better understand how their products work, enabling bolder labels, faster go/no go decisions, and improved study designs for subsequent trials. StriveStudy also supports regulatory-grade real-world evidence generation which can give rise to novel exploratory endpoints and biomarkers.
We believe that StriveStudy can provide an unparalleled benefit to researchers developing novel therapies to treat movement disorders. Our goal is to give PwPD hope – hope that effective, disease-modifying therapies will be developed in their lifetime.
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