Vertex Initiates Phase 2 Clinical Trial Program for VX-548 for the Treatment of Acute Pain
19 July 2021 - 10:00PM
Business Wire
- Proof-of-concept study of VX-548 in acute
pain following bunionectomy surgery open for enrollment -
- Second Phase 2 study of VX-548 in acute pain
following abdominoplasty surgery to begin in the coming weeks -
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today
announced that it has begun a Phase 2 proof-of-concept (POC) 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.
“Based on the favorable Phase 1 data, we are advancing this
program into Phase 2 with initiation of a dose-ranging POC study in
patients with acute pain after bunionectomy surgery followed
quickly by a second study in patients undergoing abdominoplasty
surgery. We expect to see results from the bunionectomy study by Q1
2022,” said Carmen Bozic, M.D., Executive Vice President, Global
Medicines Development and Medical Affairs, and Chief Medical
Officer at Vertex. “NaV1.8 is a genetically and pharmacologically
validated target and we are excited about the potential for VX-548
as a new class of effective pain treatments without the limitations
of current therapies, including the addictive potential of
opioids.”
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).
About VX-548
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.
About Vertex
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 (CF) — 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. For company updates and to learn more about
Vertex's history of innovation, visit www.vrtx.com or follow us on
Facebook, Twitter, LinkedIn, YouTube and Instagram.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended, including, without limitation, statements by Dr. Carmen
Bozic in this press release, and statements regarding our plans to
begin a Phase 2 study evaluating VX-548 in acute pain following
abdominoplasty surgery, the potential benefits of VX-548 as a
treatment for acute pain, and our plans, expectations and
anticipated timelines for these Phase 2 clinical studies, including
our expectations for available data. 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 risks and uncertainties that could cause actual events or
results to differ materially from those expressed or implied by
such forward-looking statements. Those risks and uncertainties
include, among other things, that data from a limited number of
patients may not be indicative of final clinical trial results,
that either or both of the studies may not be completed in the
expected timeframe, or at all, 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 the heading “Risk Factors” in
Vertex's most recent annual report and subsequent filings filed
with the Securities and Exchange Commission at www.sec.gov and
available through the company's website at www.vrtx.com. You should
not place undue reliance on these statements. Vertex disclaims any
obligation to update the information contained in this press
release as new information becomes available.
(VRTX-GEN)
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Vertex Pharmaceuticals Incorporated Investors:
Michael Partridge, +1 617-341-6108 or Brenda Eustace, +1
617-341-6187 or Manisha Pai, +1 617-429-6891 Media:
mediainfo@vrtx.com or U.S.: +1 617-341-6992 or Heather Nichols: +1
617-839-3607 or International: +44 20 3204 5275
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