Vertex’s Phase 2 study of NaV1.8 inhibitor VX-150 meets primary endpoint
Vertex Pharmaceuticals (VRTX) 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, 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.
The data announced 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 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, as recorded on a Numeric Pain Rating Scale, 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 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. 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. 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 were nausea, headache, vomiting and dizziness. 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.
VRTX closed at $154.14.
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