The Shionogi-ViiV Healthcare collaboration announced last week that it has started Phase 3 clinical trials to further evaluate its investigational next-generation integrase inhibitor S/GSK1349572 (or S/GSK572 for short). As reported at the XVIII International AIDS Conference (AIDS 2010) this summer in Vienna, S/GSK572 demonstrated potent antiviral activity and good tolerability in Phase 2 studies, including activity against HIV strains with raltegravir (Isentress) resistance mutations. The Phase 3 SPRING-2 trial will enroll treatment-naive participants, while the SAILING trial will enroll treatment-experienced patients.

Below is an edited excerpt from a ViiV-Shionogi press release describing the new studies.

Further information about the SPRING-2 trial is available from the federal government's ClinicalTrials.gov website at www.clinicaltrials.gov/ct2/show/NCT01227824.

Shionogi-ViiV Healthcare LLC Initiates Phase III Clinical Program for Investigational Once-Daily HIV Integrase Inhibitor

Phase III Treatment-naive and Treatment-experienced Trials Underway for S/GSK1349572 ('572)

London -- October 21, 2010 -- Shionogi-ViiV Healthcare LLC today announced the start of the Phase III clinical program evaluating its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 ('572). The Phase III clinical program, which began this month, includes two studies (SPRING-2 and SAILING) that will evaluate '572 in both treatment-naive patients and treatment-experienced, but integrase-naive patients.

"Progression of one of our lead pipeline compounds into late stage development for use in treatment-naive and treatment-experienced patients is an important milestone for ViiV Healthcare in its first year and ultimately we hope for those living with HIV. We believe that this clearly demonstrates the benefit of our 100% focus on HIV and commitment to delivering new or improved treatment options," stated Dr. John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare.

"We are pleased to see '572 progressing into Phase III clinical trials and are optimistic about its potential for HIV-infected patients," said Dr. Sapan Shah, President & CEO, Shionogi Inc. "As the only once-daily, unboosted integrase inhibitor in Phase III clinical development, '572 may help address certain treatment challenges that continue to face people living with HIV."

About the Phase III Trials

SPRING-2 Study Design (ING113086)

SPRING-2 is a Phase III, randomized, blinded, active-controlled, multicenter, parallel group, non-inferiority study. The study will include approximately 788 HIV-1 infected treatment-naive patients. The non-inferiority study will compare efficacy and safety outcomes of '572 and raltegravir (RAL); both treatment arms will be administered with investigator-selected dual nucleoside reverse transcriptase inhibitor therapy (either ABC/3TC [Combivir] or TDF/FTC [Truvada]).

The primary objective for SPRING-2 will be to demonstrate the antiviral activity of '572 50mg administered once-daily compared to RAL 400mg administered twice daily over 48-weeks. Secondary objectives include the assessment of antiviral activity of '572 compared to RAL at 96-weeks, to compare the tolerability, long-term safety and antiviral and immunologic activity of '572 to RAL, and to evaluate viral resistance in subjects experiencing virological failure.

SAILING Study Design (ING111762)

SAILING is a Phase III, randomized, double-blind, active-controlled, multicenter, parallel group, non-inferiority study. The study will include approximately 688 HIV-1 infected treatment-experienced, integrase-naive subjects. The non-inferiority study will assess the antiviral efficacy of '572 compared to RAL.

The primary objective for SAILING will be to demonstrate the antiviral efficacy of '572 50mg once-daily compared to RAL 400mg twice-daily both in combination with a background regimen consisting of one to two fully active agents at 48-weeks. Secondary objectives will evaluate the long-term antiviral activity, pharmacokinetics (PK), the relationship between PK and antiviral activity, tolerability and safety of '572 versus RAL.

About Shionogi-ViiV Healthcare LLC

'572 is the lead compound in Shionogi-ViiV Healthcare LLC. It is currently the only once-daily, unboosted integrase inhibitor in Phase III clinical development. Shionogi-ViiV Healthcare LLC is also developing other second-generation integrase inhibitors, including S/GSK1265744, currently in Phase II development.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline and Pfizer dedicated to delivering advances in treatment and care for people living with HIV. Our 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 visit www.viivhealthcare.com.

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-inc.com.

The full press release, including cautionary statement regarding forward-looking statements, is available at http://www.viivhealthcare.com/media-room/press-releases/2010-10-21.aspx.

10/26/10

Source

ViiV Healthcare. Shionogi-ViiV Healthcare LLC Initiates Phase III Clinical Programme for Investigational Once-Daily HIV Integrase Inhibitor. Press release. October 21, 2010.