-VX-150 was generally well tolerated and showed
statistically significant relief of acute pain compared to placebo;
study included an active reference arm of the opioid pain medicine
hydrocodone+acetaminophen to support evaluation of VX-150 treatment
effect-
-Phase 2 study in acute pain is the second
positive proof-of-concept study for VX-150 and provides further
validation for NaV1.8 inhibition in the treatment of pain-
-Vertex advances additional NaV1.8 inhibitor,
VX-128, into clinical development-
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
announced positive results of a Phase 2 study of the NaV1.8
inhibitor VX-150 in patients with acute pain following bunionectomy
surgery. Treatment with VX-150 showed statistically significant
relief of acute pain compared to placebo, as determined by the
time-weighted Sum of the Pain Intensity Difference over the first
24 hours of treatment (SPID24), a standard measure of acute pain
relief. The study also included a standard-of-care reference arm of
the commonly prescribed opioid medicine hydrocodone+acetaminophen
to support the evaluation of a potential treatment effect for
VX-150. VX-150 was generally well tolerated, and there were no
discontinuations for adverse events in any arm of the study.
This Phase 2 study is the second positive proof-of-concept study
for VX-150 and provides further validation for the use of a NaV1.8
inhibitor for the treatment of pain. A third Phase 2 study of
VX-150 is currently ongoing in neuropathic pain with data expected
in early 2019. Vertex also recently initiated a Phase 1 study of a
second NaV1.8 inhibitor, VX-128, in healthy volunteers.
“Both VX-150 and VX-128 represent an innovative new approach to
the treatment of pain, and we are encouraged to now have positive
proof-of-concept data from two studies of VX-150 that demonstrate
for the first time the potential role of NaV1.8 inhibition in the
future treatment of a variety of pain conditions,” said Jeffrey
Chodakewitz, M.D., Executive Vice President and Chief Medical
Officer at Vertex. “We look forward to generating additional data
from ongoing and planned studies of our two NaV1.8 inhibitors to
inform future development plans to bring these potentially
transformative new pain medicines to patients.”
About the Phase 2 Study in Acute Pain
The data announced today were from a Phase 2 randomized,
double-blind, placebo-controlled study that evaluated two days of
treatment with VX-150, hydrocodone+acetaminophen or placebo in 243
patients with acute pain following bunionectomy surgery. 82
patients received placebo, 80 patients received VX-150 and 81
patients received hydrocodone+acetaminophen.
Hydrocodone+acetaminophen (5mg+325mg q6h) was included as a
standard-of-care reference arm to enable better evaluation of a
potential treatment effect for VX-150. The reference arm was not
included to make statistical comparisons to VX-150. VX-150 was
dosed orally as 1500 mg for the first dose, followed by 750 mg
every 12 hours over the 48-hour treatment period.
The primary endpoint of the study was the time-weighted Sum of
the Pain Intensity Difference over the first 24 hours of treatment
(SPID24), as recorded on a Numeric Pain Rating Scale (NPRS), for
those treated with VX-150 compared to placebo. Increases in SPID24
values represent improvements in pain relief. Secondary endpoints
included safety and tolerability assessments as well as other
efficacy measurements, including SPID over the first 48 hours of
treatment (SPID48) for those treated with VX-150 compared to
placebo. Additional pre-specified analyses of other endpoints
included SPID24 and SPID48 for hydrocodone+acetaminophen compared
to placebo.
Efficacy Results
The study met its primary endpoint, showing a statistically
significant improvement in SPID24 for those treated with VX-150
compared to placebo. The SPID24 values for those treated with
VX-150 and placebo were 36.14 and 6.64, respectively. The SPID24
value for hydrocodone+acetaminophen was 40.16. Data from the
efficacy analyses are noted below:
Efficacy Outcomes Placebo
VX-150
hydrocodone+
acetaminophen
SPID24
6.64
36.14
40.16
SPID24 Treatment Difference N/A
29.50*
p<0.0001
33.52***
p<0.0001
SPID48
49.43
112.22
116.80
SPID48 Treatment Difference N/A
62.79**
p<0.0001
67.38***
p<0.0001
All p-values are based on comparing to placebo
*Primary Analysis **Secondary Analysis
***Additional Analyses
Safety Results
In this study, VX-150 was generally well tolerated. More than 90
percent of patients in each arm of the study completed treatment.
There were no discontinuations due to adverse events and there were
no serious adverse events in any arm of the study. The majority of
adverse events were mild or moderate. Adverse events were observed
in 35 percent, 31 percent and 37 percent of patients who received
placebo, VX-150 or hydrocodone+acetaminophen, respectively. The
most common adverse events (≥5% in any treatment group) were
nausea, headache, vomiting and dizziness.
Next Steps
Based on these data, Vertex plans to initiate a Phase 1 study of
VX-150 using an intravenous formulation for the treatment of acute
pain. This study is planned to begin in the second half of 2018. An
additional Phase 2 proof-of-concept study of VX-150 dosed orally is
currently ongoing in patients with neuropathic pain caused by small
fiber neuropathy. Vertex expects to obtain data from the study in
neuropathic pain in early 2019.
Vertex also today announced that it has recently initiated a
Phase 1 study of a second NaV1.8 inhibitor, VX-128, in healthy
volunteers. The study will evaluate single and multiple ascending
oral doses of VX-128 to support the initiation of a Phase 2 study
in acute pain. VX-128 is a NaV1.8 inhibitor with an enhanced
profile, including greater potency.
Upon completion of the study in neuropathic pain, Vertex will
have Phase 2 data for VX-150 in three types of pain – acute,
chronic and neuropathic pain. Data from these three Phase 2 studies
of VX-150, together with initial Phase 1 and 2 data for VX-128 and
Phase 1 data for the intravenous dosing study of VX-150, will
inform future development plans for the NaV1.8 inhibitors VX-150
and VX-128.
About Vertex
Vertex is a global biotechnology company that invests in
scientific innovation to create transformative medicines for people
with serious and life-threatening diseases. In addition to clinical
development programs in CF, Vertex has more than a dozen ongoing
research programs focused on the underlying mechanisms of other
serious diseases.
Founded in 1989 in Cambridge, Mass., Vertex's headquarters is
now located in Boston's Innovation District. Today, the company has
research and development sites and commercial offices in the United
States, Europe, Canada and Australia. Vertex is consistently
recognized as one of the industry's top places to work, including
being named to Science magazine's Top Employers in the life
sciences ranking for eight years in a row. For additional
information and the latest updates from the company, please visit
www.vrtx.com.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995,
including, without limitation, the statements in the third
paragraph of the press release and statements regarding ongoing and
planned studies of VX-150 and VX-128 and how these studies will
inform future development plans for VX-150 and VX-128. While Vertex
believes the forward-looking statements contained in this press
release are accurate, these forward-looking statements represent
the company's beliefs only as of the date of this press release and
there are a number of factors that could cause actual events or
results to differ materially from those indicated by such
forward-looking statements. Those risks and uncertainties include,
among other things, that data from the company's development
programs may not support registration or further development of its
compounds due to safety, efficacy or other reasons, and other risks
listed under Risk Factors in Vertex's annual report and quarterly
reports filed with the Securities and Exchange Commission and
available through the company's website at www.vrtx.com. Vertex
disclaims any obligation to update the information contained in
this press release as new information becomes available.
(VRTX-GEN)
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Vertex Pharmaceuticals
IncorporatedInvestors:Michael Partridge,
617-341-6108orEric Rojas, 617-961-7205orZach Barber,
617-341-6470orMedia:mediainfo@vrtx.comorNorth America:Megan
Goulart, + 1-617-341-6992orEurope & Australia:Rebecca Hunt, +44
7718 962 690
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