PainRelief.com Interview with:
Vertex Pharma Company Spokesperson

PainRelief.com: What is the background for this study? How does VX-548 work?

Response: VX-548 is an oral, selective NaV1.8 inhibitor that is highly selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that plays a critical role in pain signaling in the peripheral nervous system. NaV1.8 is a genetically validated target for the treatment of pain, and Vertex has previously demonstrated clinical proof-of-concept with a small molecule investigational treatment targeting NaV1.8 in multiple pain indications including acute pain, neuropathic pain and musculoskeletal pain.

 Vertex’s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of medicines that have the potential to provide superior relief of pain without the limitations of opioids, including their addictive potential. VX-548 is the most advanced NaV1.8 inhibitor in Vertex’s program.

PainRelief.com: What are the main findings?

·  Our Phase 2 data from two Phase 2 acute pain studies; one following abdominoplasty surgery (soft tissue) and one following bunionectomy (hard tissue), has shown a favorable benefit-risk profile with excellent consistency in safety, tolerability and efficacy across the two trials. 

·  Results from both trials showed rapid, clinically meaningful pain relief for the “high-dose” (100 mg first dose, 50 mg every 12 hrs) VX-548 and were statistically significant for the pre-specified primary end point of SPID48 difference from placebo. VX-548 was well-tolerated in both trials.  

·  The NEJM publication includes new data demonstrating VX-548’s potency and selectivity for NaV1.8, the consistency of pain relief vs. placebo over the duration of treatment and across trials, as well as information on adverse events and discontinuation rates that support an overall favorable benefit risk profile for VX-548.

·  In preclinical studies, VX-548 demonstrated high selectivity for the Na_V1.8 sodium channel (≥30,000-fold selectivity versus the other eight Na_V sodium channel subtypes). VX-548’s selectivity for the Na_V1.8 channel maximizes potency while minimizing interactions with other sodium channels.  High potency of VX-548 was measured in proprietary translational assays derived from human primary neurons isolated from the dorsal root ganglion.

·  You can view our press release we issued in March 2022 highlighting our Phase 2 data for more info. 

PainRelief.com: What should readers take away from your report?

• 548 is a novel, selective NaV1.8 inhibitor that has the potential to be a first-in-class non-opioid treatment for moderate to severe acute pain. 
• Publication of the VX-548 preclinical and Phase 2 clinical trial results in acute pain in the New England Journal of Medicine (NEJM), a prestigious medical journal with some of the most rigorous publication criteria, is a major accomplishment for our pain program and further illustrates the potential significance of VX-548.

What are the next steps for future research as a result of this study?

Response: We are working with urgency to complete the pivotal program for VX-548 in acute pain in late 2023, with results available in late 2023/early 2024.  

PainRelief.com: Is there anything else you would like to add? Any disclosures?

Response: There hasn’t been a new class of pain medicine in more than 20 years. We believe we could redefine the treatment of pain with the first new mechanism of action in decades.

Citation:

Jones J, Correll DJ, Lechner SM, Jazic I, Miao X, Shaw D, Simard C, Osteen JD, Hare B, Beaton A, Bertoch T, Buvanendran A, Habib AS, Pizzi LJ, Pollak RA, Weiner SG, Bozic C, Negulescu P, White PF; VX21-548-101 and VX21-548-102 Trial Groups. Selective Inhibition of Na_V1.8 with VX-548 for Acute Pain. N Engl J Med. 2023 Aug 3;389(5):393-405. doi: 10.1056/NEJMoa2209870. PMID: 37530822.

https://pubmed.ncbi.nlm.nih.gov/37530822/

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Last Updated on August 3, 2023 by PainRelief.com