Business Wire

Vertex Announces Treatment with the NaV1.8 Inhibitor VX-150 Showed Significant Relief of Acute Pain in Phase 2 Study

Del

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today 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 (SPID24), 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.

“Both VX-150 and VX-128 represent an innovative new approach to the treatment of pain, and we are encouraged to now have positive proof-of-concept data from two studies of VX-150 that demonstrate for the first time the potential role of NaV1.8 inhibition in the future treatment of a variety of pain conditions,” said Jeffrey Chodakewitz, M.D., Executive Vice President and Chief Medical Officer at Vertex. “We look forward to generating additional data from ongoing and planned studies of our two NaV1.8 inhibitors to inform future development plans to bring these potentially transformative new pain medicines to patients.”

About the Phase 2 Study in Acute Pain

The data announced today 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 (5mg+325mg q6h) 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 (SPID24), as recorded on a Numeric Pain Rating Scale (NPRS), 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 (SPID48) 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.

Efficacy Results

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. Data from the efficacy analyses are noted below:

Efficacy Outcomes
        Placebo       VX-150       hydrocodone+

acetaminophen

SPID24      

6.64

 

     

36.14

 

40.16

 

SPID24 Treatment Difference       N/A       29.50*

p<0.0001

33.52***

p<0.0001

SPID48      

49.43

 

     

112.22

 

116.80

 

SPID48 Treatment Difference       N/A       62.79**

p<0.0001

      67.38***

p<0.0001

All p-values are based on comparing to placebo

* Primary Analysis ** Secondary Analysis *** Additional Analyses

Safety Results

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 (≥5% in any treatment group) were nausea, headache, vomiting and dizziness.

Next Steps

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.

Vertex also today announced that it has recently initiated a Phase 1 study of a second NaV1.8 inhibitor, VX-128, in healthy volunteers. The study will evaluate single and multiple ascending oral doses of VX-128 to support the initiation of a Phase 2 study in acute pain. VX-128 is a NaV1.8 inhibitor with an enhanced profile, including greater potency.

Upon completion of the study in neuropathic pain, Vertex will have Phase 2 data for VX-150 in three types of pain – acute, chronic and neuropathic pain. Data from these three Phase 2 studies of VX-150, together with initial Phase 1 and 2 data for VX-128 and Phase 1 data for the intravenous dosing study of VX-150, will inform future development plans for the NaV1.8 inhibitors VX-150 and VX-128.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases.

Founded in 1989 in Cambridge, Mass., Vertex's headquarters is now located in Boston's Innovation District. Today, the company has research and development sites and commercial offices in the United States, Europe, Canada and Australia. Vertex is consistently recognized as one of the industry's top places to work, including being named to Science magazine's Top Employers in the life sciences ranking for eight years in a row. For additional information and the latest updates from the company, please visit www.vrtx.com.

Special Note Regarding Forward-looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, the statements in the third paragraph of the press release and statements regarding ongoing and planned studies of VX-150 and VX-128 and how these studies will inform future development plans for VX-150 and VX-128. 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 factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, 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 Risk Factors in Vertex's annual report and quarterly reports filed with the Securities and Exchange Commission and available through the company's website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Contact information

Vertex Pharmaceuticals Incorporated
Investors:
Michael Partridge, 617-341-6108
or
Eric Rojas, 617-961-7205
or
Zach Barber, 617-341-6470
or
Media:
mediainfo@vrtx.com
or
North America:
Megan Goulart, + 1-617-341-6992
or
Europe & Australia:
Rebecca Hunt, +44 7718 962 690

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Universal Laser Systems Expands Its Materials Database with Henkel, Hexcel and Saint-Gobain Materials19.6.2018 12:05Pressemelding

Universal Laser Systems (ULS) announces the addition of Henkel, Hexcel® and Saint-Gobain materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The Henkel, Hexcel and Saint-Gobain materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: Henkel Bergquist™ Gap Pad® VO Thermal Material Henkel Bergquist™ Hi-Flow® 105 Thermal Material Henkel LOCTITE® EA 7000 AERO Film Henkel Hysol® EA 9696 AERO Film Henkel Bergquist™ Sil-Pad A2000 Thermal Material Hexcel® HexForce® 353 Aramid Fabric Hexcel® HexForce® 282 Carbon Fabric Saint-Gobain CHEMFILM® DF100 Cast PTFE Film Saint-Gobain CHEMFILM® ETFE-E2 Extruded Fluoropolymer Film Laser processing notes, describing the results of the laser-material interaction fo

Valence Advises Itaúsa on Sale of Brazilian Chemical Co Elekeiroz to H.I.G. Capital19.6.2018 11:57Pressemelding

The Valence Group acted as advisor to Itaúsa on its sale of Brazilian chemical company Elekeiroz for R$160 million (EV), reduced by the net debt and proportionate to its shareholding (96.5% of total capital stock). The Company is a leading local producer of oxo-alcohols, plasticizers and anhydrides. About Itaúsa Itaúsa is a Brazilian holding company which controls several companies active in areas such as the financial sector; industries include wood panels, bathroom fittings and fixtures; infra-structure; and retail. It is one of the largest private conglomerates in Brazil and one of the largest in the world. About Elekeiroz Founded in 1894 and headquartered in Várzea Paulista – São Paulo, Elekeiroz operates in the chemicals manufacturing market. Through two production sites in Várzea Paulista and Camaçari – Bahia, the Company’s portfolio includes Oxo-Alcohols, Plasticizers, Phthalic & Maleic Anhydrides, Sulfuric Acid and other by-products. Elekeiroz has a diversified client base, com

Dole Adds Industry Veteran Michael Solomon as President of Dole Fresh Vegetables19.6.2018 10:00Pressemelding

Dole Food Company, Inc. announced the appointment of Michael H. Solomon as the new President of Dole Fresh Vegetables effective June 18, 2018. As Dole Fresh Vegetables President, Solomon will have responsibility for all of the division's operations across North America. He will report directly to Dole Food Company President and Chief Executive Officer Johan Linden. With 30 years experience, including within the food and beverage industry, Solomon has a proven success record of taking high-performance brands to the next level, increasing performance and margins in sales, plant operations, and profit growth. Among other positions, Solomon has held roles of President of POM Wonderful and President and CEO of Ready Pac Foods, Inc., prior to joining Dole. “Michael has built an impressive track record of strategic, operational and commercial accomplishments,” said Johan Linden, President and Chief Executive Officer of Dole Food Company. “He has considerable experience and knowledge of the fr

IDEMIA Selected to Deliver Its Next Generation Fingerprint Matcher Engine as Part of the UK Home Office Biometrics Programme19.6.2018 07:54Pressemelding

This award will result in the deployment of the very latest IDEMIA fingerprint matching platform, which will deliver significant productivity improvements by offering increased accuracy fingerprint services to the stakeholders and users of the HOB Programme. In the first phase of the project IDEMIA’s solution will be deployed for use by United Kingdom National Law Enforcement agencies, to be closely followed by Immigration and Border stakeholders. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180619005576/en/ (Photo: IDEMIA) IDEMIA’s solution is based upon its MBSS Search Platform1 with additional Services. MBSS is a flagship product of IDEMIA, combining very high scalability (over 1 billion identities possible), very high availability – designed for mission-critical systems – and integrating IDEMIA’S world-leading biometric algorithms. The IDEMIA award results from a competitive procurement. Initially a five year contract,

Vincent Fournier Joins Binary Tree as Chief Innovation Officer19.6.2018 07:00Pressemelding

Binary Tree has named Vincent Fournier as its first chief innovation officer, reporting to CEO Nick Wilkinson. In this critical executive management role, Vincent will lead a fast-paced, innovative, and collaborative team that helps power digital transformation. His team will develop new products and services to meet the urgent and pervasive needs of customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180619005126/en/ Vincent Fournier, Chief Innovation Officer at Binary Tree. (Photo: Business Wire) “The appointment of Vincent to this important new role is a key part of our strategy to define and accelerate the next phase of growth for Binary Tree and continue to drive our competitive advantage,” said Binary Tree CEO Nick Wilkinson. “We have a clear strategy, focused on transformation, innovation and the evolution of Binary Tree within the broader Microsoft ecosystem.” “I am thrilled to be joining Binary Tree during suc

Janssen Phase 3 Study Programme of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Presented for the First Time in Europe19.6.2018 06:00Pressemelding

The Janssen Pharmaceutical Companies of Johnson & Johnson presented for the first time in Europe data from pivotal Phase 3 clinical studies of the investigational compound esketamine nasal spray in treatment-resistant depression.1,2,3,4 The studies, conducted by Janssen Research & Development, LLC, were presented at the 31st International College of Neuropsychopharmacology (CINP) congress in Vienna, Austria. Data discussed from the Phase 3 programme included results from the maintenance phase of a long-term relapse prevention study in adults with treatment-resistant depression. The data found that continuing treatment with esketamine nasal spray plus an oral antidepressant in patients beyond 16 weeks showed clinically meaningful and statistically significant superiority to treatment with an oral antidepressant plus placebo nasal spray in delaying time to relapse of symptoms of depression. Furthermore, the data indicated that patients in stable remission treated with esketamine nasal sp