New Patent Issued Covering Serdexmethylphenidate (SDX), the Sole Active Pharmaceutical Ingredient in KP1077, Zevra’s Product Candidate for the Treatment of Idiopathic Hypersomnia (IH)
CELEBRATION, Fla., March 17, 2023 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (formerly KemPharm, 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.
To learn more about Zevra Therapeutics, its IH program and pipeline at zevra.com.
Zevra Therapeutics is a rare disease company melding science, data, and patient need to create transformational therapies for diseases with limited or no treatment options. With unique, data-driven clinical, regulatory, and commercialization strategies, the Company is overcoming complex drug development challenges to bring much-needed therapies to patients.
Arimoclomol, Zevra’s orally-delivered, first-in-class investigational product candidate for the treatment of Niemann-Pick type C (NPC), has been granted orphan drug designation, Fast Track designation, Breakthrough Therapy designation and rare pediatric disease designation for NPC by the US Food and Drug Administration (FDA), and orphan medicinal product designation for the treatment of NPC by the European Medicines Agency (EMA).
KP1077 is Zevra’s lead clinical candidate being developed to treat idiopathic hypersomnia (IH) and narcolepsy. KP1077 is comprised 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 US Drug Enforcement Agency (DEA) has classified SDX as a Schedule IV controlled substance based on evidence suggesting SDX has a lower potential for abuse when compared to d-MPH, a Schedule II controlled substance.
Early access programs are made available by Zevra Therapeutics, Inc. and its affiliates and are subject to the Company’s Early Access Program (EAP) policy as published on its website at zevra.com. Participation in these programs is subject to the laws and regulations of each jurisdiction under which each respective program is operated. Eligibility for participation in any such program is at the treating physician’s discretion.
Caution Concerning Forward Looking Statements
This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, and which can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue,” “could,” “intend,” “target,” “predict,” or the negative versions of those words or other comparable words or expressions, although not all forward-looking statements contain these identifying words or expressions. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include statements regarding: the promise and potential impact of our preclinical or clinical trial data, including without limitation the initiation, timing and results of any clinical trials or readouts, the timing or results of any Investigational New Drug (IND) applications and New Drug Application (NDA) submissions for KP1077 or any other product candidates for any specific disease indication or at any dosage, the potential patent life of the SDX-related IP portfolio, and our strategic and product development objectives. These forward-looking statements are based on information currently available to Zevra and its current plans or expectations and are subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s (formerly KemPharm’s) Annual Report on Form 10-K for the year ended December 31, 2022, and Zevra’s (formerly KemPharm’s) other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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