Sleep Consortium, Inc.

On July 31, 2024, Avadel Pharmaceuticals announced that the first patient has been dosed in REVITALYZ, a Phase 3 study evaluating LUMRYZ as a potential treatment for idiopathic hypersomnia (IH).⁠ ⁠ REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 study designed to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose, in IH. The study will enroll approximately 150 adults who are diagnosed with IH and includes an open label extension portion. REVITALYZ enrollment is open for both participants switching from immediate-release oxybates and not currently taking oxybates.⁠ ⁠ The primary objective of REVITALYZ is to demonstrate reduction in daytime sleepiness as measured by the primary endpoint, change in total score of the Epworth Sleepiness Scale (ESS) at Week 14. Secondary endpoints will evaluate the effect of LUMRYZ on additional efficacy parameters including patient and clinician impression of change, idiopathic hypersomnia severity, and a measure of the functional outcomes of sleep.⁠ ⁠ Click here to learn more - https://lnkd.in/eW8pmM8F

Exciting news from Harmony Biosciences ! The FDA has approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in pediatric patients with narcolepsy. As the first and only non-scheduled treatment option for children 6 years and older, this approval represents a significant advancement in addressing the unmet needs of young patients living with this challenging condition. Kudos to Harmony Biosciences for their dedication to improving the lives of those affected by narcolepsy. This is a major step forward in our mission to enhance treatment options for all who suffer from central disorders of hypersomnolence. #Narcolepsy #PediatricCare #FDAApproval #WAKIX #SleepDisorders

Global Gene's RARE-X and Sleep Consortium Launch Sleep Data Collection Initiative to Accelerate Development of Therapies The Sleep Data Collection Initiative, the first consortium on the RARE-X platform for the collection and sharing of patient-owned data, brings together patient advocacy organizations, researchers, and drug developers looking to address shared symptoms across multiple Sleep-related conditions by leveraging RARE-X's existing investment in its platform, data governance, and data model. Global Genes' research program RARE-X opened enrollment for their collaboration with the Sleep Consortium to accelerate the development of effective treatments for central disorders of hypersomnolence and related conditions. To read more, click the link below. Jazz Pharmaceuticals, Avadel Pharmaceuticals plc, Alkermes, Harmony Biosciences, Takeda, Zevra Therapeutics, Centessa Pharmaceuticals

During the SLEEP 2024 annual meeting in Houston, Zevra Therapeutics announced positive final results from the Phase 2 clinical trial of KP1077. The placebo-controlled double-blind trial evaluated the safety and tolerability of KP1077 in patients with idiopathic hypersomnia. Results demonstrated that KP1077 was well tolerated and showed meaningful clinical improvements in patient-reported daytime sleepiness, sleep inertia, and brain fog. To read the key takeaways from Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia, click here - https://lnkd.in/eRcGV-63

🚨 New Resource! 🚨 Sleep Consortium has produced new patient guidelines, which are designed to offer patient guidance and education on central disorders of hypersomnolence (CDoH), including narcolepsy, idiopathic hypersomnia, and Kleine-Levin syndrome. They offer a comprehensive description of each sleep disorder, including diagnostic practices and treatment options– increasing understanding for people living with CDoH, shared decision-making with healthcare providers, and effective disease management. Click on the link to access your digital copy: https://lnkd.in/erRuafg6 For more information about Central Disorders of Hypersomnolence and to keep up to date on patient resources and the new data collection portal, please visit: https://lnkd.in/ecwYHUMh We are grateful to our consortium community members for supporting the advancement of research and patient outcomes. #Sleepconosrtium #Idiopathichyperosmnia #Narcolepsy #Kleinelevin #CDOH #excessivedaytimesleepiness #sleepresearch #sleepdisorder #sleephealth #insomnias #sleephelp #fatigue #sleepeductaion #patientguidelines #sleepsupport #chronicillness #beyondsleepy #clinicallytired #sleepy

Sleep Consortium announces the launch of a global groundbreaking Data Collection Portal to advance research in Central Disorders of Hypersomnolence. The Patient owned data platform signifies a new era in accelerating disease understanding utilizing AI and Machine Learning by interconnecting data across rare and non-rare disease areas. Full Press Release is here: https://lnkd.in/emZbShcB

We heard from so many of you living with IH and your care partners at the April 11 Illuminate Hypersomnia meeting. The community came together and shed light on what it’s like to live with IH. View the recording from the EL-PFDD meeting at bit.ly/illuminate-IH. The quest to illuminate hypersomnia continues. By May 11, add your voice to those we have heard from so far by responding to the survey, completing your survey response, or submitting a written comment. Learn more at bit.ly/illuminate-IH. #IHPFDD #IlluminateIH #idiopathichypersomnia #livingwithIH #livingwithidiopathichypersomnia #idiopathichypersomnolence #PFDD #patientfocused #sleepconsortium #thisisIH Hypersomnia Foundation Project Sleep PWN4PWN Day4NAPs Hypersomnolence Australia

The Vibrance-1 Study for Narcolepsy Type 1 is Now Enrolling. NOW RECRUITING people diagnosed with narcolepsy type 1 (NT1) aged 18 to 70. The purpose of this study is to research the safety and effectiveness of an investigational study drug taken orally once daily and how it may work in adults with NT1. Individuals with NT1 may be eligible for the Vibrance-1 Study. Orexin is a chemical in the brain that helps regulate the sleep/wake cycle. The investigational study drug, ALKS 2680, is an orexin-2 receptor agonist and may improve symptoms of sleep disorder, such as excessive daytime sleepiness (EDS) and cataplexy, in patients with NT1. Individuals will be evaluated by the study team to determine their eligibility to participate in this research. Each individual who qualifies will receive either the study drug or a placebo, as well as study-related medical exams and study-related laboratory tests, at no cost. Compensation for time and travel may also be available. To learn more: Visit VibranceStudies.com

The sleep community is coming together to launch a new data initiative to accelerate research and insights into sleep-related disorders. Join us for the launch party Monday, April 29, 2024, at 11 am EST to hear more about the initiative, how the data will be used, and learn how to register to begin sharing information about your experiences. RSVP today! https://lnkd.in/gpj2XZBB Matthew Horsnell will be discussing "Data Ownership Empowers Patients." Matt Horsnell is a husband, father of three, and sleep advocate living with NT1 (narcolepsy with cataplexy) and obstructive sleep apnea. As an author-advocate, he has published research on lived experience and sleep disorders. Matt also works as a consultant for the pharmaceutical industry and behavioral sleep projects.   Matt was recognized as Project Sleep’s Inaugural Sleep Advocacy Champion (2023). Additionally, he facilitates weekly online groups for Wake Up Narcolepsy, and is the Co-Host of Hypersomnia Foundation’s UNIGHT. Matt has been a featured guest in webinars and podcasts including Project Sleep, SBSM, and AACSM.   Matt is a leading legislative advocate for Project Sleep and a graduate of their Rising Voices program. He presented on Sleep Health Equity to The White House (2023). 

On April 11, 2024 Harmony Biosciences announced an exclusive licensing agreement with Bioprojet to develop, manufacture and commercialize TPM-1116, a highly potent and selective oral orexin-2 receptor (OX2R) agonist that will be evaluated for the treatment of narcolepsy and other sleep/wake disorders. Narcolepsy and other hypersomnolence disorders continue to be a large market opportunity with significant unmet medical need. The agreement will accelerate the development of this orexin-2 receptor agonist and is expected to further Harmony’s leadership in the sleep/wake space, reinforcing its commitment to advancing innovative treatments for patients living with unmet medical needs, according to Jeffrey M. Dayno, M.D., Harmony Biosciences President and CEO. “Orexin agonism is an exciting area of sleep disorder research and represents the next novel mechanism of action for the treatment of narcolepsy since the launch of WAKIX. We also see potential synergies between TPM-1116 and our lead product, WAKIX, and new formulations of pitolisant, because of the interplay between histamine and orexin in the hypothalamus,” Dayno said. “We believe TPM-1116, a new chemical series of orexin 2 agonist, could emerge with a potential best-in-class clinical profile based on its potency and selectivity, along with its strong preclinical safety profile and potential for once daily dosing.” For more details, please read the press release here - https://lnkd.in/epNmzD6h