Biogen Inc. (Nasdaq: BIIB) today announced positive topline results
from its Phase 2 CONVEY study of vixotrigine (BIIB074),
a non-opioid investigational oral pain drug being
evaluated for the treatment of small fiber neuropathy (SFN).
The CONVEY study 200 mg twice daily arm met its primary endpoint
of change from baseline to week 12 of the double-blind period in
mean average daily pain (ADP) score. In this study, all
participants who enrolled received the higher dose (350 mg twice
daily) in an open-label portion which preceded the double-blind
portion of the study. While the 350 mg twice daily arm did not meet
the primary endpoint, it met statistical significance in the
Patient Global Impression of Change (PGIC) at week 12, an important
self-reported measure of a patient’s overall improvement since with
the start of the study. The totality of data from the vixotrigine
program will inform potential doses for study in future Phase 3
clinical trials. There is a significant unmet need for non-opioid
treatments for people suffering from chronic neuropathic pain.
Small fiber neuropathy is often characterized by severe pain
that typically begins in the feet or hands. Painful symptoms are
described as burning, shooting and/or prickling. Pain can be caused
by stimuli that does not normally provoke pain (allodynia) and
potentially painful stimuli are increased in intensity
(hyperalgesia). Symptoms tend to be worse at night and during
periods of rest and can lead to a significant impact on overall
quality of life.
“We are encouraged by the overall results of the CONVEY study,
especially given the significant unmet medical need for additional
agents to treat chronic painful neuropathy,” said Katherine Dawson,
M.D., Senior Vice President, and Head of the Therapeutics
Development Unit at Biogen. “We are grateful to all the
participants, investigators and study staff who contributed to this
study and allowed us to evaluate vixotrigine as a non-opioid
treatment option for people living with chronic neuropathic pain
due to small fiber neuropathy.”
CONVEY Topline Study Results CONVEY was a Phase
2 placebo-controlled, double-blind, enriched enrollment, randomized
withdrawal study that evaluated the efficacy and safety of
vixotrigine in treating pain experienced by participants with
confirmed idiopathic or diabetes mellitus-associated small fiber
neuropathy. Statistical testing to compare each vixotrigine dose
with placebo was pre-defined at the 10% significance level without
multiplicity adjustment.
Vixotrigine 200 mg twice daily resulted in a statistically
significant reduction in the mean average daily pain (ADP) score
versus placebo at week 12 (p=0.0501). Treatment effect was noted in
participants with diabetes mellitus based on a subgroup analysis
but was not evident in the smaller subgroup of patients with
idiopathic SFN. The 200 mg dose also resulted in statistically
significant improvement versus placebo on the mean worst daily pain
score at week 12 (p=0.0455). Numeric advantage of 200 mg over
placebo was observed in additional secondary endpoints, including
the proportion of participants with a 2-point or greater
improvement in the average daily pain score and the proportion of
participants with ≥30% reduction in ADP at week 12, but these did
not meet statistical significance.
Vixotrigine 350 mg twice daily did not meet the primary endpoint
of mean change in ADP at week 12. However, treatment with 350 mg
vixotrigine resulted in a statistically significant increase in the
proportion of participants who reported they were “very much
improved” or “much improved” when compared to baseline, using the
Patient Global Impression of Change (PGIC) questionnaire
(p=0.0580). In addition, numeric advantage of 350 mg over placebo
was observed in some secondary endpoints, including the proportion
of participants with a 2-point or greater improvement in the
average daily pain score and the proportion of participants with
≥30% reduction in ADP at week 12, but these did not meet
statistical significance.
Both doses of vixotrigine were generally well tolerated and
the safety profile was consistent with previous studies of
vixotrigine with no evidence of abuse potential. In the open-label
period, common AEs (incidence ≥ 2.5%) were dizziness, headache,
vertigo, and nausea. 5.3% of subjects discontinued the open-label
part of the study due to adverse events; across the entire study
the majority of the AEs were mild or moderate in
severity.
Biogen will further evaluate the CONVEY data and plans to
complete a Phase 1 clinical study to inform potential next steps in
the development of vixotrigine. In addition, detailed results from
the CONVEY study will be made available in a future scientific
forum.
About vixotrigine (BIIB074)Vixotrigine
(BIIB074) is an investigational peripherally and centrally acting,
orally administered, voltage- and use-dependent voltage-gated
sodium channel blocker. Sodium channels are important for nerve
impulse conduction, including within pain-sensitive neurons which
respond to tissue damage and within the pain pathway in the spinal
cord and brain.
About the CONVEY Study
(NCT03339336)CONVEY was a Phase 2
placebo-controlled, double-blind, enriched enrollment randomized
withdrawal study that enrolled 265 patients to evaluate the
efficacy and safety of vixotrigine (BIIB074) in treating pain
experienced by participants with confirmed small fiber neuropathy
that is idiopathic or associated with diabetes mellitus. After a
4-week open-label run-in period, 123 responders to vixotrigine were
randomized to receive either 200 mg or 350 mg vixotrigine or
placebo twice-daily for 12 weeks in the double-blind portion of the
study.
The primary objective of the study is based on change from
baseline to week 12 of the double-blind period in the mean average
daily pain score on an 11-point numeric rating scale. The secondary
objectives of this study are to evaluate the effect on worst pain,
neuropathic pain quality, sleep interference due to pain, patient
global impression, use of rescue medication, and SFN symptoms in
participants treated with vixotrigine; to investigate the safety
and tolerability of vixotrigine in participants with SFN; and to
characterize the pharmacokinetics of vixotrigine in participants
with SFN. For more information about the CONVEY study, visit
https://clinicaltrials.gov/ct2/show/NCT03339336.
About small fiber neuropathy (SFN)Small fiber
neuropathy (SFN) is a type of peripheral neuropathy characterized
by degeneration of small-diameter sensory fibers, including those
responsible for pain. SFN can be idiopathic or associated with
conditions such as diabetes, immune-mediated diseases, infections,
or toxic substances and may also involve multiple sensory and
autonomic symptoms. Diabetes and impaired glucose tolerance are the
most common causes of SFN. For a significant portion of patients,
SFN is idiopathic as no cause can be identified. With no treatments
indicated specifically for this type of neuropathic pain and with
other pain medications, there is a high unmet medical need for new
effective and safe therapies.
About BiogenAt Biogen, our mission is clear: we
are pioneers in neuroscience. Biogen discovers, develops and
delivers worldwide innovative therapies for people living with
serious neurological and neurodegenerative diseases as well as
related therapeutic adjacencies. One of the world’s first global
biotechnology companies, Biogen was founded in 1978 by Charles
Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners
Walter Gilbert and Phillip Sharp. Today Biogen has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first approved treatment for spinal muscular atrophy,
commercializes biosimilars of advanced biologics and is focused on
advancing research programs in multiple sclerosis and
neuroimmunology, Alzheimer’s disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, neuropsychiatry,
immunology, acute neurology and neuropathic pain.
We routinely post information that may be important to investors
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Biogen Safe Harbor StatementThis news release
contains forward-looking statements, including statements made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including statements about results
from the Phase 2 CONVEY study of vixotrigine; the potential
clinical effects of vixotrigine; the potential benefits, safety and
efficacy of vixotrigine; the clinical development program for
vixotrigine; the identification and treatment of pain; our research
and development program for the treatment of pain; the potential of
our commercial business and pipeline programs, including
vixotrigine; and risks and uncertainties associated with drug
development and commercialization. These forward-looking statements
may be accompanied by words such as “aim,” “anticipate,” “believe,”
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of similar meaning. Drug development and commercialization involve
a high degree of risk and only a small number of research and
development programs result in commercialization of a product.
Results in early stage clinical trials may not be indicative of
full results or results from later stage or larger scale clinical
trials and do not ensure regulatory approval. You should not place
undue reliance on these statements or the scientific data
presented.
These statements involve risks and uncertainties that could
cause actual results to differ materially from those reflected in
such statements, including without limitation, uncertainty of
success in the development and potential commercialization of
vixotrigine; the risk that we may not fully enroll our clinical
trials or enrollment will take longer than expected; unexpected
concerns may arise from additional data, analysis or results
obtained during our clinical trials; regulatory authorities may
require additional information or further studies, or may fail or
refuse to approve or may delay approval of our drug candidates,
including vixotrigine; the occurrence of adverse safety events; the
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MEDIA CONTACT:Allison Parks+ 1 781 464
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