Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the
Company) a commercial-stage rare disease therapeutics company,
today announced that Rene Braeckman, Ph.D., Zevra’s Senior Vice
President of Clinical Development, will present top-line data from
the placebo-controlled, double-blind, randomized withdrawal Phase 2
clinical trial (NCT05668754) evaluating the safety and tolerability
of KP1077 (serdexmethylphenidate, or SDX) in patients with
idiopathic hypersomnia (IH) at Sleep Europe 2024, the 27th Congress
of the European Sleep Research Society (ESRS) being held
in Seville, Spain, September 24-27, 2024.
Presentation Details
Oral PresentationTitle: Safety and Efficacy of
KP1077 in a Phase 2, Placebo-Controlled, Double-Blind, Randomized
Withdrawal Study in Patients with Idiopathic HypersomniaDate/Time:
Friday, September 27, 2024, 8:20 a.m. – 8:30 a.m. CETLocation:
Auditorium 1
Poster PresentationTitle: Safety and Efficacy of
KP1077 in a Phase 2, Placebo-Controlled, Double-Blind, Randomized
Withdrawal Study in Patients with Idiopathic HypersomniaDate/Time:
Thursday, September 26, 2024, 12:00 noon – 1:30 p.m. CET, and 5:30
p.m. – 6:45 p.m. CETCategory: NeurologyNumber: P771
About Sleep Europe 2024
- The biennial congress of the
European Sleep Research Society “Sleep Europe” is Europe’s leading
congress on sleep medicine and sleep research. Every two years,
thousands of clinicians, researchers, scientists, students &
trainees come together to learn the latest sleep science news and
network with their peers. For more information you can access the
full program online here:
https://esrs.eu/sleep-congress/scientific-programme/
About the KP1077 Phase 2
Trial
The Phase 2 clinical trial (NCT05668754) was a
double-blind, placebo-controlled, randomized-withdrawal,
dose-optimizing, multi-center study that evaluated the safety and
efficacy of KP1077 for the treatment of IH. Part 1 of the trial
consisted of a 5-week open-label dose titration phase during which
patients were optimized to one of four doses of KP1077 (80, 160,
240, or 320 mg/day). Part 2 of the trial entailed a two-week
randomized, double-blind, withdrawal phase, during which two-thirds
of the trial participants continued to receive their optimized dose
while the remaining one-third received placebo. Participants were
assigned into two evenly divided cohorts. The first cohort received
a single daily dose just before bedtime, and the second cohort
received half the daily dose shortly after awakening and the second
half prior to bedtime. Zevra enrolled 66 adult patients with IH in
24 centers in the U.S. into the open-label titration
phase of the study and 50 of those patients continued into the
double-blind phase.
The primary endpoint was the safety and
tolerability of KP1077. The major secondary efficacy endpoint was
the change in Epworth Sleepiness Scale (ESS) total score.
Additional secondary endpoints included the IH Severity Scale
(IHSS), the Sleep Inertia Visual Analog Scale (SIVAS), and a new
scale to assess the symptoms and severity of brain fog.
About Idiopathic
Hypersomnia
Idiopathic hypersomnia (IH) is a rare sleep
disorder characterized by excessive daytime sleepiness (EDS).
Patients with IH experience daytime lapses into sleep, or an
irrepressible need to sleep that persists even with adequate or
prolonged nighttime sleep. Additionally, those with IH have extreme
difficulty waking, otherwise known as sleep inertia, severe brain
fog, and often fall asleep unintentionally or at inappropriate
times. These symptoms of IH often lead to further, even more
debilitating problems such as memory lapses, difficulty maintaining
focus, and depression. It is estimated, based on claims data, that
approximately 37,000 patients in the United States are
currently diagnosed with IH, although the total patient population
may be much larger due to some patients who have not yet been
diagnosed, have been misdiagnosed, or are not currently seeking
treatment.
About KP1077
KP1077 (serdexmethylphenidate or SDX) is Zevra’s
proprietary prodrug of d-methylphenidate (d-MPH) and its sole
active pharmaceutical ingredient (API). KP1077 has been granted
Orphan Drug Designation by the U.S. Food and Drug
Administration (FDA), and by the European Commission, for
the treatment of IH. The U.S. Drug Enforcement
Agency (DEA) has classified SDX, the sole API in KP1077, 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. In addition, KP1077 has intellectual
property protection through 2037 and potentially beyond.
About Zevra Therapeutics,
Inc.
Zevra Therapeutics, Inc. is a commercial-stage
rare disease company combining science, data, and patient needs to
create transformational therapies for diseases with limited or no
treatment options. Our mission is to bring life-changing
therapeutics to people living with rare diseases. With unique,
data-driven development and commercialization strategies, the
Company is overcoming complex drug development challenges to make
new therapies available to the rare disease community.
Expanded access programs are made available by
Zevra Therapeutics, Inc. and its affiliates and are subject to the
Company's Expanded Access Program (EAP) policy, as published on its
website. 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.
For more information, please
visit www.zevra.com or follow us on X (formerly Twitter)
and LinkedIn.
Cautionary Note 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,” “would,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “assume,” “intend,” “potential,” “continue”
or other similar words or the negative of these terms, although not
all forward-looking statements contain these identifying words or
expressions. Forward-looking statements are not guarantees of
future actions or performance. Forward-looking statements include
all statements that do not relate solely to historical or current
facts, including without limitation statements regarding
anticipated consummation of the proposed offering, market
conditions, the satisfaction of customary closing conditions
related to the proposed offering, the completion of the offering on
the anticipated terms or at all and general economic conditions.
Forward-looking statements are based on information currently
available to Zevra and its current plans or expectations. They are
subject to several known and unknown uncertainties, risks, and
other important factors that may cause Zevra’s 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 Annual Report on Form 10-K for the year ended December 31,
2023, subsequent Quarterly Reports on Form 10-Q, and other filings
with the SEC. While Zevra may elect to update such forward-looking
statements at some point in the future, except as required by law,
Zevra disclaims any obligation to do so, even if subsequent events
cause Zevra’s views to change. Although Zevra believes the
expectations reflected in such forward-looking statements are
reasonable, Zevra cannot assure that such expectations will prove
correct. These forward-looking statements should not be relied upon
as representing Zevra’s views as of any date after the date of this
press release.
Zevra Contact
Nichol Ochsner+1 (732) 754-2545nochsner@zevra.com
Russo Partners ContactsDavid Schull+1 (858)
717-2310david.schull@russopartnersllc.com
Ignacio Guerrero-Ros, Ph.D.+1 (646)
942-5604Ignacio.guerrero-ros@russopartnersllc.com
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