DUBLIN, June 20,
2024 /PRNewswire/ -- Jazz Pharmaceuticals plc
(Nasdaq: JAZZ) today announced top-line results from the Phase
2b clinical trial (NCT05122650)
evaluating the efficacy and safety of suvecaltamide (JZP385), an
investigational, highly selective and state-dependent modulator of
T-type calcium channels, in adult patients with essential tremor
(ET). Suvecaltamide did not achieve statistical significance at
30mg versus placebo on the primary endpoint of change from baseline
to week 12 on the Essential Tremor Rating Assessment Scale (TETRAS)
modified composite outcome score and key secondary endpoint of
Clinical Global Impression-Severity (CGI-S) scale.
While not statistically significant, numeric improvements were
observed on the primary endpoint and key secondary endpoint at 30mg
versus placebo. The improvement in placebo from baseline to week 12
also exceeded the Company's expectations and was higher than what
was observed for placebo in the prior T-CALM trial of
suvecaltamide.
"We are disappointed that the trial did not meet its primary
endpoint. We recognize the significant unmet need for people living
with ET, and we are grateful to the patients, their families and
the investigators that participated in the trial," said
Rob Iannone, M.D., M.S.C.E.,
executive vice president, global head of research and development
of Jazz Pharmaceuticals. "We are evaluating the data to better
understand the trial results and await the results of the
suvecaltamide trial in Parkinson's disease tremor to determine next
steps for the program. The Phase 2 Parkinson's disease tremor trial
is ongoing with results expected first quarter 2025."
Suvecaltamide was well tolerated and the overall safety profile
was consistent with previous studies with no new safety
signals observed. The most common treatment-emergent adverse events
(TEAEs) were dizziness, headache, paresthesia, diarrhea and
insomnia. These were predominately mild to moderate in
severity. One participant experienced a serious adverse event
considered treatment related by the investigator.
About the Phase 2b
Trial
The Phase 2b clinical
trial (NCT05122650) is a 12-week, multicenter, double-blind,
randomized, placebo-controlled trial evaluating the efficacy and
safety of suvecaltamide in a once-daily oral dose of 10, 20 and
30mg or placebo. The primary endpoint (modified TETRAS composite
outcome score) represents items 1-11 from the TETRAS-ADL combined
with items 6+7 (spiral and handwriting assessments, respectively)
from the TETRAS-PS with scoring modifications. The key secondary
endpoint in the trial measured the percentage of participants with
≥1 point improvement on CGI-S. The trial randomized 420
participants from four countries.
About Suvecaltamide
Suvecaltamide (JZP385) is an
investigational, highly selective and state-dependent modulator of
T-type calcium channels (Cav3). T-type calcium channels
play a role in the brain's control of muscle movement.1
Suvecaltamide preferentially binds to stabilize a specific
conformation of the channel and reduce activity. The suvecaltamide
Phase 2 proof-of-concept trial in Parkinson's disease tremor is
ongoing (NCT05642442).
About Jazz Pharmaceuticals
Jazz Pharmaceuticals
plc (Nasdaq: JAZZ) is a global biopharmaceutical company whose
purpose is to innovate to transform the lives of patients and their
families. We are dedicated to developing life-changing medicines
for people with serious diseases — often with limited or no
therapeutic options. We have a diverse portfolio of marketed
medicines, including leading therapies for sleep disorders and
epilepsy, and a growing portfolio of cancer treatments. Our
patient-focused and science-driven approach powers pioneering
research and development advancements across our robust pipeline of
innovative therapeutics in oncology and neuroscience. Jazz is
headquartered in Dublin, Ireland,
with research and development laboratories, manufacturing
facilities and employees in multiple countries committed to serving
patients worldwide. Please visit
www.jazzpharmaceuticals.com for more information.
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including,
but not limited to, statements related to potential timing of data
availability from the JZP385 trial in Phase 2 Parkinson's disease
tremor and other statements that are not historical facts. These
forward-looking statements are based on Jazz Pharmaceuticals'
current plans, objectives, estimates, expectations and intentions
and inherently involve significant risks and uncertainties. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
and uncertainties associated with pharmaceutical product
development, and other risks and uncertainties affecting Jazz
Pharmaceuticals and its development programs, including those
described from time to time under the caption "Risk Factors" and
elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange
Commission filings and reports (Commission File No. 001-33500),
including Jazz Pharmaceuticals' Annual Report on Form 10-K for the
year ended December 31, 2023, as
supplemented by our Quarterly Report on Form 10-Q for the quarter
ended March 31, 2024, and future
filings and reports by Jazz Pharmaceuticals. Other risks and
uncertainties of which Jazz Pharmaceuticals is not currently aware
may also affect Jazz Pharmaceuticals' forward-looking statements
and may cause actual results and the timing of events to differ
materially from those anticipated. The forward-looking statements
herein are made only as of the date hereof or as of the dates
indicated in the forward-looking statements, even if they are
subsequently made available by Jazz Pharmaceuticals on its website
or otherwise. Jazz Pharmaceuticals undertakes no obligation to
update or supplement any forward-looking statements to reflect
actual results, new information, future events, changes in its
expectations or other circumstances that exist after the date as of
which the forward-looking statements were made.
Media Contact:
Kristin
Bhavnani
Head of Global Strategic Brand Engagement
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
Ireland +353 1 637 2141
U.S. +1 215 867 4948
Investors:
Andrea N. Flynn, Ph.D.
Vice President, Head, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
Ireland +353 1 634 3211
U.S. +1 650 496 2717
References:
1 Papapetropoulos S, Lee
MS, Boyer S, Newbold EJ. A Phase 2, Randomized,
Double-Blind, Placebo-Controlled Trial of CX-8998, a Selective
Modulator of the T-Type Calcium Channel in Inadequately Treated
Moderate to Severe Essential Tremor: T-CALM Study Design and
Methodology for Efficacy Endpoint and Digital Biomarker Selection.
Front Neurol. 2019;10:597. Published 2019 Jun 11.
doi:10.3389/fneur.2019.0059.
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SOURCE Jazz Pharmaceuticals plc