- Tavapadon met the primary endpoint in the pivotal Phase 3,
TEMPO-1 fixed-dose monotherapy trial, demonstrating a statistically
significant improvement from baseline in the MDS-UPDRS Parts II and
III combined score at week 26
- Trial also met key secondary endpoint, demonstrating
statistically significant improvement from baseline in the
MDS-UPDRS Part II score
- Results from the Phase 3 TEMPO-2 trial,
studying tavapadon as a flexible-dose monotherapy, are
expected by the end of 2024
NORTH
CHICAGO, Ill., Sept. 26,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced positive topline results from its pivotal Phase 3 TEMPO-1
trial for tavapadon as a monotherapy in early Parkinson's disease.
Tavapadon is an investigational D1/D5 dopamine receptor partial
agonist being studied as a once-daily treatment for Parkinson's
disease.
The TEMPO-1 trial evaluated the efficacy, safety and
tolerability of two fixed doses (5 mg and 15 mg, once daily) of
tavapadon as a monotherapy in adults with early Parkinson's
disease. The trial met its primary endpoint – patients treated with
tavapadon in both dose groups experienced a statistically
significant reduction (improvement) from baseline compared to
placebo (placebo: +1.8; 5 mg: -9.7; 15 mg: -10.2; p-value
<0.0001 each dose versus placebo) in the Movement Disorder
Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Parts II and III combined score at week 26.
The TEMPO-1 trial also met the key secondary endpoint,
demonstrating a statistically significant and clinically meaningful
improvement in motor aspects of experiences of daily living
(MDS-UPDRS Part II) in both tavapadon dose groups compared to
placebo at week 26.
"The TEMPO-1 data, coupled with the previously reported TEMPO-3
adjunctive trial findings, further support the potential of
tavapadon for people living with Parkinson's disease," said Primal
Kaur, MD, MBA, senior vice president, immunology, neuroscience, eye
care and specialty development, AbbVie. "This marks a significant
step forward in our commitment to enhancing our neuroscience
portfolio following the strategic acquisition of Cerevel
Therapeutics and further demonstrates our dedication to supporting
patients at all stages of this challenging neurological condition.
We look forward to sharing additional data later this year from the
TEMPO-2 monotherapy trial."
The safety profile observed in the TEMPO-1 trial was consistent
with prior clinical trials.1,2 The majority of adverse
events reported were mild to moderate in severity.
Full results from the TEMPO-1 study will be submitted for
presentation at future medical meetings and used to support
regulatory submissions of tavapadon as a treatment for Parkinson's
disease. Topline results from TEMPO-2, the Phase 3 flexible-dose
monotherapy trial for tavapadon, are expected by the end of
2024.
About Parkinson's Disease
Parkinson's disease is a chronic neurodegenerative disorder. It
primarily results in progressive and debilitating motor symptoms,
including decreased bodily movement, slowness of movement,
rigidity, tremors and postural instability, all of which result
from the loss of dopamine-producing neurons in the
brain.3
About Tavapadon
Tavapadon is a selective D1/D5 receptor partial agonist in
development for Parkinson's disease and is currently being studied
as a once-daily medicine for use as both a monotherapy and as an
adjunctive therapy to levodopa. The safety and efficacy of
investigational tavapadon has not been established.
TEMPO Clinical Development Program
The TEMPO clinical development program is evaluating the
efficacy, safety and tolerability of tavapadon across a broad
Parkinson's disease population, including two monotherapy Phase 3
trials (TEMPO-1 and TEMPO-2) and one adjunctive Phase 3 trial
(TEMPO-3). AbbVie is also conducting a fourth, open-label extension
(OLE) trial (TEMPO-4) to assess the long-term safety and
tolerability of tavapadon.
TEMPO-1 was a Phase 3 double-blind, randomized,
placebo-controlled, parallel-group, 27-week trial to evaluate the
efficacy, safety and tolerability of two fixed doses of tavapadon
as a monotherapy in early Parkinson's disease. The primary endpoint
was the change from baseline in the MDS-UPDRS Parts II and III
combined score. Key secondary endpoints included change from
baseline in the MDS-UPDRS Parts II score and percentage of
responders with "much improved" or "very much improved" on the
Patient Global Impression of Change (PGIC).
The MDS-UPDRS was developed to evaluate various aspects of
Parkinson's disease including non-motor and motor experiences of
daily living and motor complications. It includes a motor
evaluation and characterizes the extent and burden of disease
across various populations.4 Part II contains 13
sub-scores for the motor experiences of daily living and Part III
contains 33 sub-scores based on 18 items, several with right, left
or other body distribution scores for the motor examination. The
sub-score for each is summed to calculate the total scores. The
scale range for Part II+III Total Score is 0-184 (Part II maximum
total score of 52 + Part III maximum total score of 132). The
higher the score the greater the severity. A negative change from
baseline represents an improvement in motor
function.5
A total of 529 adults between the ages of 40-80 were enrolled in
the trial. All had a confirmed diagnosis of Parkinson's disease and
had disease duration (from time of diagnosis) of less than three
years. Patients were randomized to receive tavapadon titrated to 5
milligrams, tavapadon titrated to 15 milligrams or placebo, orally
and once-daily.
More information on the TEMPO trials can be found on
www.clinicaltrials.gov:
TEMPO-1: NCT04201093
TEMPO-2: NCT04223193
TEMPO-3: NCT04542499
TEMPO-4: NCT04760769
About AbbVie in Neuroscience
At AbbVie, our commitment to preserving personhood of people
around the world living with neurological and psychiatric disorders
is unwavering. With more than three decades of experience in
neuroscience, we are providing meaningful treatment options today
and advancing innovation for the future. AbbVie's Neuroscience
portfolio consists of approved treatments in neurological
conditions, including migraine, movement disorders and psychiatric
disorders, along with a robust pipeline of transformative
therapies. We have made a strong investment in research and are
committed to building a deeper understanding of neurological and
psychiatric disorders. Every challenge makes us more determined and
drives us to discover and deliver advancements for those impacted
by these conditions, their care partners and clinicians. For more
information, visit www.abbvie.com.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions that solve serious health issues today and address
the medical challenges of tomorrow. We strive to have a remarkable
impact on people's lives across several key therapeutic areas –
immunology, oncology, neuroscience, and eye care – and products and
services in our Allergan Aesthetics portfolio. For more information
about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on
LinkedIn, Facebook, Instagram, X (formerly Twitter), and
YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be
considered, forward-looking statements for purposes of the Private
Securities Litigation Reform Act of 1995. The words "believe,"
"expect," "anticipate," "project" and similar expressions and uses
of future or conditional verbs, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2023 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
References
- Sohur US, Gray DL, Duvvuri S, Zhang Y, Thayer K, Feng G. Phase
1 Parkinson's Disease Studies Show the Dopamine D1/D5 Agonist
PF-06649751 is Safe and Well Tolerated. Neurol Ther.
2018;7(2):307-319. doi: 10.1007/s40120-018-0114-z.
- Riesenberg R., Werth J., Zhang Y., Duvvuri S., Gray D.
PF-06649751 efficacy and safety in early Parkinson's disease: A
randomized, placebo-controlled trial. Ther. Adv. Neurol.
Disord. 2020;13:1756286420911296. doi:
10.1177/1756286420911296.
- DeMaagd G, Philip A. Parkinson's
Disease and Its Management: Part 1: Disease Entity, Risk Factors,
Pathophysiology, Clinical Presentation, and Diagnosis. P T. 2015
Aug;40(8):504-32. PMID: 26236139; PMCID: PMC4517533.
- MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS).
International Parkinson and Movement Disorder Society. Accessed on
September 20, 2024.
https://www.movementdisorders.org/MDS/MDS-Rating-Scales/MDS-Unified-Parkinsons-Disease-Rating-Scale-MDS-UPDRS.htm
- Fixed-Dose Trial in Early Parkinson's Disease (PD) (TEMPO-1).
National Library of Medicine. Accessed on September 20, 2024.
https://clinicaltrials.gov/study/NCT04201093
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