Press Release
Vertex Announces Treatment with the NaV1.8 Inhibitor VX-150 Showed Significant Relief of Acute Pain in Phase 2 Study
-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-
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
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
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
(VRTX-GEN)
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