| |
Shionogi-ViiV Healthcare announces completion of initial clinical registration package for dolutegravir in HIV
|
| |
| |
London, United Kingdom, 4 October 2012: Shionogi-ViiV Healthcare LLC today announced that the phase III data required for initial regulatory filings of the investigational integrase inhibitor dolutegravir in adults infected with HIV are in house. Data from the two phase III studies in treatment-experienced patients (VIKING-3 and SAILING) have been received and will be the subject of future presentations at scientific meetings. Together with previously disclosed data from the SPRING-2 and SINGLE studies in treatment-naive patients, these additional study data support Shionogi-ViiV Healthcare's plans to commence global regulatory submissions for dolutegravir before the end of 2012. Dolutegravir is not yet approved as a treatment for HIV or any other indication anywhere in the world.
About the VIKING-3 and SAILING studies in treatment-experienced adults with HIV-1
VIKING-3 (ING112574) is an ongoing Phase III, multicentre, open-label, single arm study to assess the antiviral activity and safety of dolutegravir 50mg twice-daily in treatment-experienced adults with HIV-1 and historical or current evidence of resistance to raltegravir or elvitegravir.
SAILING (ING111762) is an ongoing Phase III, multicentre, double blind, double dummy study to compare the efficacy and safety of dolutegravir 50mg once-daily to raltegravir 400mg twice-daily in treatment-experienced, integrase inhibitor-naive adults with HIV-1.
The full results of these studies will be presented at upcoming scientific meetings.
About the SPRING-2 and SINGLE studies in treatment-naive adults with HIV-1
SPRING-2 (ING113086) is an ongoing Phase III, multicentre, double blind, double dummy study to compare the efficacy and safety of dolutegravir 50mg once-daily to raltegravir 400mg twice-daily in treatment-naïve adults with HIV-1. Full 48-week data from SPRING-2 were presented at the International AIDS Conference in July 2012.
SINGLE (ING114467) is an ongoing Phase III, multicentre, double blind, double dummy study to compare the efficacy and safety of once-daily dolutegravir 50mg plus abacavir/lamivudine versus Atripla (tenofovir/emtricitabine/efavirenz). Full 48-week data from SINGLE were presented at ICAAC in September 2012. Together with data from an ongoing bioequivalence study (ING114580), SINGLE is designed to support additional regulatory submissions for a fixed dose combination of dolutegravir/abacavir/lamivudine.
IAC: Once-Daily Dolutegravir(DTG; S/GSK1349572) is Non-Inferior to Raltegravir (RAL) in Antiretroviral-naïve Adults. 48 Week results from SPRING-2 (ING113086) - (07/26/12)
IAC: Phase 1/2, Multicenter, Open-label, Pharmacokinetic, Safety, Tolerability, and Antiviral Activity Study of Dolutegravir (DTG), a Novel Integrase Inhibitor, in Combination Regimens in HIV-1 Infected Infants, Children, and Adolescents: P1093 - (07/26/12)
ICAAC:Dolutegravir (DTG; S/GSK1349572) + Abacavir/Lamivudine Once Daily Statistically Superior to Tenofovir/Emtricitabine/Efavirenz: 48-Week Results - SINGLE (ING114467) - (09/10/12)
About Dolutegravir
S/GSK1349572 (dolutegravir) is an investigational integrase inhibitor (INI) currently in development by Shionogi-ViiV Healthcare LLC for the treatment of HIV for use in combination with other HIV medicines. Dolutegravir is being evaluated for safety and efficacy without an additional 'booster' drug being added to the regimen. Integrase inhibitors block HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Given the stage of development of this investigational HIV therapy, the full picture of the efficacy and safety of dolutegravir has not been conclusively determined.
About Shionogi-ViiV Healthcare LLC
The Shionogi-ViiV Healthcare LLC is a joint venture between Shionogi & Co., Ltd. and ViiV Healthcare Ltd., a global company with a sole focus on HIV established in 2009 by GlaxoSmithKline and Pfizer, Inc. Dolutegravir is the lead compound in the Shionogi-ViiV Healthcare LLC partnership. Shionogi-ViiV Healthcare LLC is also developing another integrase inhibitor which is at an earlier stage of development.
About Shionogi & Co., Ltd
Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi's Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company is the originator of innovative medicines which have been successfully delivered to millions of patients worldwide. In addition, Shionogi is engaged in new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp. For more information on Shionogi Inc. headquartered in Florham Park, NJ, please visit www.shionogi.com.
About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and new HIV medicines as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visitwww.viivhealthcare.com.
| |
| |
| |
|
|
|
