Biotech Values

[DewDiligence]

GSK Starts Phase-3 Trials for ‘572 Integrase Inhibitor

[S/GSK1349572 (nickname ‘572) is an HIV integrase inhibitor that GSK (d/b/a/ Shionogi-ViiV Healthcare) hopes can supplant MRK’s Isentress. (‘572 is also a potential candidate for combination with IDIX’s IDX899, but that’s not the subject of this PR.) Phase-2b data for ‘572 is in #msg-52728888 and #msg-52730834.

Two phase-3 trials, one in the first-line and one in the second-line, will test ‘572 vs Isentress when each is added to a standard dual-nuke backbone. The primary and secondary endpoints, described below, are typical for phase-3 HIV trials. The goal is non-inferiority of ‘572 to Isentress, the idea being that qD dosing (which Isentress does not have) will enable ‘572 to be incorporated into an Atripla-like combo pill. (GILD’s Elvitegravir, an integrase inhibitor in phase-3 that’s a component of ‘Quad’, requires PK-boosting to be given qD.)]

http://finance.yahoo.com/news/ShionogiViiV-Healthcare-LLC-prnews-1547763028.html?x=0&.v=1

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

Source: Shionogi-ViiV Healthcare LLC
October 21, 2010, 4:00 am EDT

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 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 [Isentress] (RAL); both treatment arms will be administered with investigator-selected dual nucleoside reverse transcriptase inhibitor therapy (either ABC/3TC or TDF/FTC) [i.e. the dual-nuke backbone will be either Truvada or Epzicom].

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 [Isentress].

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.‹