CORRECTION: Axovant Announces Negative Results for Intepirdine in Phase 2b HEADWAY and Pilot Phase 2 Gait and Balance Studies...
January 09 2018 - 7:00AM
Axovant Sciences (NASDAQ:AXON) today announced a correction to the
data related to the Company’s investigational drug nelotanserin
previously reported in its January 8, 2018 press release. In the
results of the pilot Phase 2 Visual Hallucination study, the
post-hoc subset analysis of patients with a baseline Scale for the
Assessment of Positive Symptoms - Parkinson's Disease (SAPS-PD)
score of greater than 8.0 was misreported. The previously reported
data for this population (n=19) that nelotanserin treatment at 40
mg for two weeks followed by 80 mg for two weeks resulted in a 1.21
point improvement (p=0.011, unadjusted) were incorrect. While
nelotanserin treatment at 40 mg for two weeks followed by 80 mg for
two weeks did result in a 1.21 point improvement, the p-value was
actually 0.531, unadjusted. Based on these updated results, the
Company will continue to discuss a larger confirmatory nelotanserin
study with the U.S. Food and Drug Administration (FDA) that is
focused on patients with dementia with Lewy bodies (DLB) with motor
function deficits. The Company may further evaluate nelotanserin
for psychotic symptoms in DLB and Parkinson’s disease dementia
(PDD) patients in future clinical studies.
About the Nelotanserin Visual Hallucinations
Study This multi-center, randomized, double-blind,
placebo-controlled, pilot Phase 2 crossover study evaluated the
safety, tolerability, and efficacy of nelotanserin over a four-week
treatment period and enrolled 30 patients with DLB and PDD who were
experiencing frequent and recurrent visual hallucinations. With the
crossover design, every patient received placebo for four weeks and
nelotanserin for four weeks (two weeks of a 40 mg dose followed by
two weeks of an 80 mg dose). Study participants were allowed to be
on stable antipsychotic treatments, stable anti-Parkinson’s disease
treatments, and stable background cholinesterase inhibitor therapy
for at least four weeks prior to screening.
The prespecified primary endpoint of the pilot study was safety
including assessment of extrapyramidal symptoms as measured by the
change in UPDRS scores. In addition, there were multiple
exploratory efficacy assessments in the study that included UPDRS
Part III, SAPS, SAPS-PD, PGIC-VH and an internally developed
patient diary, that evaluated the effects of nelotanserin over a
four-week treatment period. Individuals who completed this study
were eligible to receive nelotanserin in an extension study.
About DLBDementia with Lewy bodies (DLB) is a
progressive neurodegenerative disorder characterized by the
aggregation of Lewy bodies, abnormal deposits of a protein called
alpha-synuclein. Lewy bodies build up in areas of the brain that
regulate behavior, cognition and movement. DLB is the second most
prevalent cause of neurodegenerative dementia in elderly patients.
Approximately 1.1 million patients in the United States have DLB.
Patients with DLB can present with a range of symptoms including
fluctuations in cognition, attention and alertness; Parkinson’s
symptoms; visual hallucinations; and REM sleep behavior disorder
(RBD), in which people physically act out their dreams, impacting
their quality of life and endangering their bed partners. No
therapies are approved for the treatment of DLB in the United
States or Europe.i
About Nelotanserin Nelotanserin is a selective
inverse agonist of the 5-HT2A receptorii that was discovered by
Arena Pharmaceuticals, Inc.
About Axovant SciencesAxovant is a
clinical-stage biopharmaceutical company focused on developing and
commercializing innovative medicines to broadly address multiple
forms of dementia and related neurological disorders. Axovant is
developing a pipeline of product candidates that focuses on the
cognitive, functional and behavioral aspects of debilitating
conditions such as Alzheimer's disease, Lewy body dementia and
other neurological disorders. For more information, visit
www.axovant.com.
Forward-Looking Statements This press release
contains forward-looking statements, including statements regarding
Axovant’s plans for the development of nelotanserin.
Forward-looking statements can be identified by the words
“believe,” “anticipate,” “continue,” “estimate,” “project,”
“expect,” “plan,” “potential,” “intends,” “will,” “would,” “could,”
“should” or the negative or plural of these words or other similar
expressions that are predictions or indicate future events, trends
or prospects. Forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
and reported results should not be considered as an indication of
future performance. These risks and uncertainties include, but are
not limited to: risks associated with the success, cost and timing
of our product development activities and clinical trials,
increased regulatory requirements, and interim results or other
preliminary analyses do not ensure that later or final results in a
clinical trial or in related or similar clinical trials will
replicate those interim results. There can be no assurance that any
of our product candidates will ever receive regulatory approval or
be successfully commercialized. For a further description of the
risks and uncertainties that could cause actual results to differ
from those expressed in these forward-looking statements, as well
as risks relating to Axovant’s business in general, see the “Risk
Factors” section of our quarterly report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) on November 2, 2017,
and other filings that Axovant makes with the SEC from time to
time. These forward-looking statements are based on information
available to Axovant as of the date of this press release and speak
only as of the date of this release. Axovant disclaims any
obligation to update these forward-looking statements, except as
may be required by law.
Contacts:Investors &
Media
Samina Bari
Vice President,
Corporate Affairs
investors@axovant.com
media@axovant.com
MediaBrian ReidW2O Group
breid@w2ogroup.com 402.875.0525
_____________________________i Alzheimer's Association.
Dementia with Lewy bodies.
http://www.alz.org/dementia/dementia-with-lewy-bodies-symptoms.asp.
Accessed January 7, 2018.ii The Journal of Pharmacology and
Experimental Therapeutics. Nelotanserin, a novel selective human
5-hydroxytryptamine2A inverse agonist for the treatment of
insomnia. http://www.ncbi.nlm.nih.gov/pubmed/19841476. 2010
Jan;332(1):281-90. doi: 10.1124/jpet.109.160994. Epub 2009 Oct
19.
Axon Enterprise (NASDAQ:AXON)
Historical Stock Chart
From Mar 2024 to Apr 2024
Axon Enterprise (NASDAQ:AXON)
Historical Stock Chart
From Apr 2023 to Apr 2024