19 July 2021 - - US-based biotechnology company Vertex Pharmaceuticals Inc. (NASDAQ: VRTX) has begun a Phase 2 proof-of-concept study in acute pain following bunionectomy surgery with the selective NaV1.8 inhibitor VX-548 and that it expects to commence a second Phase 2 study in acute pain following abdominoplasty surgery in the coming weeks, the company said.

The Phase 2 studies are randomized, double-blind, placebo-controlled trials that will evaluate multiple doses of VX-548 in patients with acute pain following bunionectomy surgery or abdominoplasty surgery. Both studies will also include a hydrocodone bitartrate /acetaminophen reference arm.

The primary endpoint in both studies is the time-weighted Sum of the Pain Intensity Difference over the first 48 hours of treatment (SPID48).

VX-548 is an oral, selective NaV1.8 inhibitor that has completed Phase 1 studies in healthy volunteers. Based on a favorable pharmacokinetic, safety and tolerability profile, it was advanced to Phase 2 studies in 2021.

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 novel 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 acute pain without the limitations of opioids, including their addictive potential.

VX-548 is the most recent molecule to enter clinical development from Vertex's portfolio of NaV1.8 inhibitors.

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases.

The company has multiple approved medicines that treat the underlying cause of cystic fibrosis, a rare, life-threatening genetic disease, and has several ongoing clinical and research programs in CF.

Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases.

In addition, Vertex has a rapidly expanding pipeline of cell and genetic therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London.

Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America.

Vertex is consistently recognized as one of the industry's top places to work, including 11 consecutive years on Science magazine's Top Employers list and a best place to work for LGBTQ equality by the Human Rights Campaign.