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Collaboration for New Way to Assess Treatment for Lupus Patients

Wednesday, December 6, 2017  
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AMPEL BioSolutions, a biomedical research firm based in Charlottesville, Va., Horizon Pharma plc and The Lupus Research Alliance have launched RIFLE (RAYOS (delayed release prednisone) Inhibits Fatigue in Lupus Erythematosus) trial for patients with Systemic Lupus Erythematosus (SLE). The RIFLE trial will utilize Horizon Pharma's proprietary prednisone delayed-release tablets, RAYOS®, to address the daily cycling of cortisol and inflammatory mediators known as circadian rhythm. RAYOS therapy capitalizes on this known rhythm of cortisol production to provide steroid when it is most needed to counteract the symptoms of SLE. Other unique features of this trial include the focus on controlling fatigue, one of the most frequent unaddressed symptoms lupus patients experience and the use of a novel smartphone/smartwatch combination to capture patient reported outcomes.

Earlier this year, a group of American researchers won the 2017 Nobel Prize in physiology for medicine with their pioneering efforts to more fully understand circadian rhythm. The RIFLE study will build upon this knowledge to focus treatment specifically at the time during the day when the endogenous immunoregulator, cortisol, is the lowest and thereby control disease activity more effectively. RAYOS, taken at 10 p.m., results in delivery of prednisone to the body around 2 a.m., which is optimal for prednisone anti-inflammatory therapy, but an inconvenient time for patients to take their medicine. RAYOS accomplishes the convenient delivery of prednisone when it is most needed and as a result, the inflammatory symptoms of SLE, especially those experienced in the morning when disease activity is usually greatest, can be reduced.

The RIFLE trial, part of the Lupus Research Alliance LuCIN effort to promote the development of novel safe and effective lupus therapies, is a Phase 4 clinical trial with 21 participating universities and medical facilities. The trial will assess whether Horizon Pharma's RAYOS can effectively control morning fatigue— the number one symptom of Lupus patients – better than more standard immediate-release prednisone; the trial will also assess whether the novel smartphone/smartwatch app can identify responses to therapy more quickly and more precisely.

The novel mobile phone app developed by AMPEL will collect patient reported outcomes data from the study by asking participants questions daily, in real time, as symptoms are occurring and being treated. In addition, the app will engage trial participants with weekly questions and, with use of a smart watch, track patients' activity and sleep patterns, to determine effectiveness of the RAYOS treatment in comparison with the standard immediate-release prednisone. Commonly in clinical trials, patients are asked questions on a monthly basis which results in much more general answers. As patients experience symptoms in real time, they will be able to input data through the mobile app, which intends to provide more specific and accurate data for researchers.

Dr. Peter Lipsky, Co-founder of AMPEL, said, "We are pleased to initiate the RIFLE trial and this effort to more effectively treat morning symptoms by building upon knowledge of circadian rhythms. The availability of Horizon Pharma's RAYOS – a delayed-release prednisone— is a very promising treatment that we hope to see validated for SLE with the help of the novel smartphone/smartwatch app, LuPRO. It is our hope that the app will provide researchers with real-time measurements of patients' fatigue, quality of life, disease activity, and morning stiffness in order to allow a comprehensive assessment of the treatment's ability to provide relief for patients with these troublesome symptoms of lupus."

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