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

LONDON, Oct. 21 /PRNewswire/ — Shionogi-ViiV Healthcare LLC
today announced the start of the Phase III clinical programme
evaluating its once-daily, unboosted investigational integrase
inhibitor, S/GSK1349572 (‘572). The Phase III clinical programme,
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 TrialsSPRING-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 or TDF/FTC).

The primary objective for SPRING-2 will be to demonstrate the
antiviral activity of ‘572 50mg administered once-daily compared to
RAL 400mg administere

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