Saturday, March 18, 2023
Zevra Therapeutics, Inc., a rare disease therapeutics company, today announced that it has joined the Sleep Data Initiative as a founding member. The new data collection platform is led by RARE-X and the Sleep Consortium to provide access to research-grade, patient-owned data to support the acceleration of research and treatment development for sleep disorders.
“Marking World Sleep Day today, we are proud to announce this important collaboration and our role as a founding member of this significant initiative to support acceleration and advancement of sleep research programs,” said Richard W. Pascoe, Chief Executive Officer of Zevra. “The data being generated by our clinical program for KP1077, our novel therapy intended for the treatment of idiopathic hypersomnia (IH), will support the research and development of effective treatments for rare sleep disorders through the use of this vital platform.”
RARE-X is a research program and data collection platform sponsored by Global Genes. The platform is currently supporting 83 disease communities, with about 58 percent of participants having reported sleep disturbance as a phenotype. Sleep Consortium is a not-for-profit organization working to support research and drug development for Central Disorders of Hypersomnolence (CDH) and other related sleep disorders.
“As a founding member of the Sleep Data Initiative, Zevra Therapeutics recognizes the need for collaboration to develop creative solutions to improve the lives of patients with sleep disorders,” said Lindsay Jesteadt, Ph.D., Chief Executive Officer and Co-Founder of Sleep Consortium. “Their funding support for the sleep data collection initiative demonstrates their commitment to the wellbeing of individuals living with CDH, both diagnosed and undiagnosed. This partnership supports the broader ecosystem of sleep health as we embark on unprecedented acceleration of research and treatment options.”
In addition, Zevra Therapeutics announced that U.S. Patent No. 11,505,537 from the United States Patent and Trademark Office (USPTO) was issued for its patent application entitled, “Compositions Comprising Methylphenidate-Prodrugs, Processes of Making and Using the Same.” The patent provides methods of use governing d-methylphenidate conjugates and/or salts thereof for treating excessive daytime sleepiness associated with central hypersomnia disorders, including IH and narcolepsy in various dosage forms. Zevra is currently investigating KP1077 in a Phase 2 clinical trial for the treatment of IH.
This patent expands Zevra’s intellectual property estate for serdexmethylphenidate (SDX), which includes methods of use for methylphenidate conjugates to provide extended release of d-methylphenidate (USPTO No. 10,954,212). Currently, patents covering SDX, which is the sole active pharmaceutical ingredient in KP1077, extends until at least 2037.