- Tavapadon met the primary endpoint in the pivotal Phase 3
TEMPO-2 flexible-dose monotherapy trial, demonstrating a
statistically significant improvement from baseline in the
MDS-UPDRS Parts II and III combined score at week
261
- Trial also met its key secondary endpoint, demonstrating
statistically significant improvement from baseline in
the MDS-UPDRS Part II score at week 261
- Positive results across all three Phase 3 TEMPO trials
demonstrate the potential of tavapadon as a first-in-class
D1/D5 partial agonist in Parkinson's disease
- AbbVie is on track to submit an NDA for tavapadon to the FDA
in 2025
NORTH
CHICAGO, Ill., Dec. 9, 2024
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive
topline results from its pivotal Phase 3 TEMPO-2 trial evaluating
investigational tavapadon as a flexible-dose monotherapy in early
Parkinson's disease. Tavapadon is the first and only D1/D5 partial
agonist under investigation as a once-daily treatment for
Parkinson's disease.
The TEMPO-2 trial evaluated the efficacy, safety and
tolerability of a flexible-dose (5 mg to 15 mg, once daily)
treatment with tavapadon as a monotherapy in adults with early
Parkinson's disease. The trial met its primary endpoint – patients
treated with tavapadon experienced a statistically significant
reduction (improvement) from baseline compared to placebo (placebo:
-1.2; tavapadon 5-15 mg: -10.3; p-value <0.0001 versus placebo)
in the Movement Disorder Society - Unified Parkinson's Disease
Rating Scale (MDS-UPDRS) Parts II and III combined score at week
26.1
The TEMPO-2 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 the tavapadon group (5-15 mg) compared to
placebo at week 26.1
"The positive results across all three Phase 3 TEMPO trials
underscore the potential of tavapadon as a first-in-class D1/D5
partial agonist for the treatment of Parkinson's disease," said
Primal Kaur, M.D., MBA, senior vice president, immunology,
neuroscience, eye care and specialty development, AbbVie. "With
these data in hand, we look forward to working with regulatory
agencies to assess next steps, bringing us one step closer to
providing tavapadon for those living with this chronic,
debilitating disease."
The safety profile observed in the TEMPO-2 trial was consistent
with prior clinical trials.1,2,6 The majority of adverse
events reported were mild to moderate in severity.1
"Parkinson's disease imposes a profound burden on individuals
living with this challenging neurological condition, significantly
affecting their quality of life and management of daily activities.
Right now, there is still an unmet need for treatments that deliver
efficacy while minimizing unwanted side effects," said Hubert H. Fernandez, M.D., global principal
investigator and the James and Constance Brown endowed chair in
movement disorders, professor of neurology and director at the
Center for Neurological Restoration at Cleveland Clinic. "The
results from TEMPO-2, and across the entire TEMPO clinical
development program, add to the growing evidence which suggests
that tavapadon has the potential to offer an important new option
for individuals living with Parkinson's disease."
Full results from the TEMPO-2 trial will be submitted for
presentation at a future medical meeting. AbbVie is on track to
submit the New Drug Application (NDA) to the U.S. Food & Drug
Administration (FDA) in 2025.
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 the first and only selective D1/D5 receptor partial
agonist under investigation 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 evaluated 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-2 was a Phase 3 double-blind, randomized,
placebo-controlled, parallel-group, 27-week trial to evaluate the
efficacy, safety and tolerability of flexible doses of tavapadon
(5-15 mg QD) 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 304 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 5-15 mg QD or
placebo, orally and once daily.
AbbVie plans to submit an NDA for tavapadon leveraging data from
the TEMPO program to the FDA in 2025.
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
- AbbVie. Data on file ABVRRTI79943.
- 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
- Flexible-Dose Trial in Early Parkinson's Disease (PD)
(TEMPO-2). National Library of Medicine. Accessed on December 2, 2024.
https://clinicaltrials.gov/study/NCT04223193
- 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.
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