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▎WuXi AppTec content team editors Today, Vertex Pharmaceuticals announced that its investigational selective NaV1.
8 channel inhibitor VX-548 has two Phase 2 proofs of concept in the treatment of acute pain after abdominoplasty or bunionectomy Positive results in clinical trials
.
High-dose VX-548 treatment resulted in a rapid, statistically significant and clinically meaningful improvement in the primary endpoint of pain compared to placebo
.
Based on these positive results, Vertex plans to advance the pivotal clinical development of VX-548 in the second half of this year, following discussions with regulatory agencies
.
VX-548 is an oral selective inhibitor of NaV1.
8, which is highly selective for NaV1.
8 compared to other NaV ion channels
.
NaV1.
8 is a voltage-gated sodium channel that plays a key role in pain signaling in the peripheral nervous system
.
It is a genetically validated pain treatment target
.
Vertex's strategy is to selectively inhibit NaV1.
8 to develop new types of drugs that may offer better pain relief than opioids while avoiding side effects such as addiction
.
In a Phase 2 clinical trial in abdominoplasty patients, VX-548 met the primary endpoint, with a statistically significant increase in pain score SPID48 in patients treated with high doses of VX-548 compared to placebo
.
The higher the SPID48 score, the better the pain relief effect
.
Please see the figure below for specific data
.
Image source: Reference [1] In a phase 2 clinical trial for the treatment of bunionectomy, high-dose VX-548 achieved similar efficacy and significantly improved patients' SPID48 scores
.
Image source: Reference [1] In terms of safety, VX-548 is well tolerated, and there are no serious adverse events related to VX-548
.
Dr.
Carmen Bozic, Chief Medical Officer and Executive Vice President, Global Pharmaceutical Development and Medical Affairs, Vertex, said: "VX-548 demonstrated excellent consistency in efficacy, safety and tolerability across the two trials
.
Potential for a potential 'first-in-class' non-opioid pain relief therapy
.
We are accelerating this program into Phase 3 clinical development with the goal of delivering the first innovative pain relief therapy in decades to address an unmet patient need
.
" Reference Source: [1] Vertex Announces Statistically Significant and Clinically Meaningful Results From Two Phase 2 Proof-of-Concept Studies of VX-548 for the Treatment of Acute Pain.
Retrieved March 31, 2022, from https://news.
vrtx.
com /press-release/vertex-announces-statistically-significant-and-clinically-meaningful-results-twoDisclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.
8 channel inhibitor VX-548 has two Phase 2 proofs of concept in the treatment of acute pain after abdominoplasty or bunionectomy Positive results in clinical trials
.
High-dose VX-548 treatment resulted in a rapid, statistically significant and clinically meaningful improvement in the primary endpoint of pain compared to placebo
.
Based on these positive results, Vertex plans to advance the pivotal clinical development of VX-548 in the second half of this year, following discussions with regulatory agencies
.
VX-548 is an oral selective inhibitor of NaV1.
8, which is highly selective for NaV1.
8 compared to other NaV ion channels
.
NaV1.
8 is a voltage-gated sodium channel that plays a key role in pain signaling in the peripheral nervous system
.
It is a genetically validated pain treatment target
.
Vertex's strategy is to selectively inhibit NaV1.
8 to develop new types of drugs that may offer better pain relief than opioids while avoiding side effects such as addiction
.
In a Phase 2 clinical trial in abdominoplasty patients, VX-548 met the primary endpoint, with a statistically significant increase in pain score SPID48 in patients treated with high doses of VX-548 compared to placebo
.
The higher the SPID48 score, the better the pain relief effect
.
Please see the figure below for specific data
.
Image source: Reference [1] In a phase 2 clinical trial for the treatment of bunionectomy, high-dose VX-548 achieved similar efficacy and significantly improved patients' SPID48 scores
.
Image source: Reference [1] In terms of safety, VX-548 is well tolerated, and there are no serious adverse events related to VX-548
.
Dr.
Carmen Bozic, Chief Medical Officer and Executive Vice President, Global Pharmaceutical Development and Medical Affairs, Vertex, said: "VX-548 demonstrated excellent consistency in efficacy, safety and tolerability across the two trials
.
Potential for a potential 'first-in-class' non-opioid pain relief therapy
.
We are accelerating this program into Phase 3 clinical development with the goal of delivering the first innovative pain relief therapy in decades to address an unmet patient need
.
" Reference Source: [1] Vertex Announces Statistically Significant and Clinically Meaningful Results From Two Phase 2 Proof-of-Concept Studies of VX-548 for the Treatment of Acute Pain.
Retrieved March 31, 2022, from https://news.
vrtx.
com /press-release/vertex-announces-statistically-significant-and-clinically-meaningful-results-twoDisclaimer: The WuXi AppTec content team focuses on introducing global biomedical health research progress
.
This article is for information exchange purposes only, and the views expressed in this article do not represent WuXi AppTec's position, nor do they represent WuXi AppTec's support or opposition to the views expressed in this article
.
This article is also not a treatment plan recommendation
.
For guidance on treatment options, please visit a regular hospital
.