Zevra Therapeutics Announces Collaboration with RARE-X and the Sleep Consortium as Founding Member of New Sleep Data Initiative
New Patent Issued Covering Serdexmethylphenidate (SDX), the Sole Active Pharmaceutical Ingredient in KP1077, Zevra’s Product Candidate for the Treatment of Idiopathic Hypersomnia (IH)
“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
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.
“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
In addition, Zevra Therapeutics announced that
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
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
Early access programs are made available by
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
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