Lindus Health, the "anti-CRO" running radically faster, more reliable clinical trials, and Tiefenbacher Group, a leading healthcare company providing best-in-class solutions along the entire pharmaceutical value chain, have announced their collaboration on a clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

ME/CFS is a long-term condition characterized by extreme fatigue, decreased cognitive function ("brain fog"), and other symptoms related to pain and dizziness. It is a relatively common condition that affects approximately 1% of the population. Despite its prevalence and impact on quality of life, ME/CFS remains poorly understood, with a critical shortage of effective treatment options for patients.

This Phase 2 trial, ReMEdi, will evaluate the efficacy of a therapeutic with proven success to treat symptoms of other fatigue-related conditions.

ReMEdi will adopt a virtual trial model, making it easier for patients with ME/CFS to complete study activities while offering a flexible, patient-centric solution for participation. Recruitment will be conducted primarily through social media advertising, with pre-screening facilitated through Lindus Health's home-grown eClinical technology, Citrus™. The platform will also be utilized to streamline data capture through electronic patient reported outcomes (ePROs) and carry out telehealth visits with the study team. Participants will be required to wear the Oura ring for continuous remote monitoring and use the GripAble device for hand grip testing.

"Symptoms of ME/CFS can drastically diminish quality of life, and we're humbled to have the opportunity to contribute to Tiefenbacher's efforts to rewrite the narrative for this patient population," said Meri Beckwith, co-founder of Lindus Health. "By leveraging our virtual site services and eClinical platform, we're making participation more accessible while ensuring the collection of high-quality data to propel ME/CFS research."

"ME/CFS can be incredibly debilitating, keeping people from doing their usual activities or even actively living their life," said Dr Simon Bock, Project & Market Access Manager of Tiefenbacher Group. "ReMEdi showcases our dedication to identifying novel treatment strategies that can alleviate symptoms and improve patient outcomes. We're excited to be working with Lindus Health to help us better understand ME/CFS in our mission to bring a one-of-a-kind treatment to the hands of these patients."

Tiefenbacher and Lindus Health are dedicated to shaping a future in which conditions like ME/CFS are more clearly understood, and patients benefit from safe, effective treatments that significantly enhance their quality of life.