Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (formerly KemPharm, Inc.), a rare disease therapeutics company, has joined forces with the Sleep Data Initiative, led by RARE-X and the Sleep Consortium, to help revolutionize the treatment and research of sleep disorders. By providing access to research-grade, patient-owned data, the initiative will play a vital role in speeding up the process of developing treatments for these disorders. Zevra Therapeutics is proud to be a founding member of this groundbreaking initiative.
Today, on World Sleep Day, we are proud to announce our partnership as a founding member of the Sleep Disorder Research Acceleration and Advancement Initiative, a significant move to support research into rare sleep disorders. Our clinical program for KP1077, a novel therapy intended to treat idiopathic hypersomnia (IH), will provide valuable data to help develop effective treatments for these medical conditions. We are excited to be part of this important initiative and look forward to contributing to its success.
RARE-X, the research program and data collection platform sponsored by Global Genes, is a powerful tool for 83 disease communities. Of these, 58% of participants have reported sleep disturbances, indicating the importance of this issue. To support research and drug development for Central Disorders of Hypersomnolence (CDH) and other related sleep disorders, the Sleep Consortium, a not-for-profit organization, is dedicated to finding solutions.
Zevra Therapeutics proudly stands at the forefront of the Sleep Data Initiative, understanding the importance of working together to develop better treatments for those living with sleep disorders. By contributing to the sleep data collection initiative, Zevra has shown their commitment to improving the lives of those with CDH, both diagnosed and undiagnosed. This partnership is a major stepping stone to advancing sleep health research and treatments, and will undoubtedly benefit many individuals in the future.
Zevra Therapeutics recently achieved a major milestone, with the USPTO granting the company a patent for its application entitled, “Compositions Comprising Methylphenidate-Prodrugs, Processes of Making and Using the Same.”
This patent covers the use of d-methylphenidate conjugates and/or salts thereof to treat excessive daytime sleepiness associated with central hypersomnia disorders, including IH and narcolepsy, in various dosage forms. Zevra is now advancing KP1077 in a Phase 2 clinical trial for the treatment of IH, having taken a giant step forward in the pursuit of a potential new therapy for this condition.
Zevra’s patent portfolio for serdexmethylphenidate (SDX) has been bolstered to include methods of use for methylphenidate conjugates to provide extended release of d-methylphenidate (USPTO No. 10,954,212). This affords Zevra exclusive rights to SDX until at least 2037 – the sole active pharmaceutical ingredient in KP1077.
About Zevra
Zevra Therapeutics is on a mission to revolutionize the way rare diseases are treated. By leveraging data-driven clinical, regulatory, and commercialization strategies, the Company is pushing the boundaries of drug development and making new treatments available to those who need them most. With a commitment to uniting science and patient need, Zevra is making a real difference in the lives of those living with rare and untreatable diseases.
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Arimoclomol, Zevra’s investigational product candidate for the treatment of Niemann-Pick type C (NPC), several prestigious designations: orphan drug designation, Fast Track designation, Breakthrough Therapy designation, rare pediatric disease designation, and orphan medicinal product designation. This is a major step forward for the potential treatment of NPC.
KP1077, Zevra’s lead clinical candidate, is being developed to treat idiopathic hypersomnia and narcolepsy. It’s composed solely of serdexmethylphenidate (SDX), Zevra’s proprietary prodrug of d-methylphenidate (d-MPH).
The FDA has granted KP1077 orphan drug designation for the treatment of IH, and the DEA has classified SDX as a Schedule IV controlled substance due to its lower potential for abuse relative to d-MPH, which is a Schedule II controlled substance. With this relief, KP1077 could open up new opportunities in the treatment of sleep disorders.
Gain exclusive access to Zevra Therapeutics, Inc.’s groundbreaking treatments with our Early Access Program! Our EAP allows you to experience our innovative solutions before anyone else. Simply have your treating physician assess your eligibility and you can be on your way to a healthier future. All of our programs are operated in accordance with the laws and regulations of each jurisdiction, so you can be sure you are in safe, capable hands.