Biotech Values

[DewDiligence]

GSK Advances ‘572 Integrase Inhibitor to Phase-3

[S/GSK1349572 (nickname ‘572) is the HIV integrase inhibitor that GSK (d/b/a/ ViiV Healthcare) plans to test in a “nuke-sparing” trial with IDIX’s IDX899 (#msg-48915175). GSK in-licensed the drug from Japan’s Shionogi, who is the author of this PR. (‘Shionogi-ViiV Healthcare LLC’ is the subordinate JV within ViiV [itself a JV between GSK and PFE] to hold title to the Shionogi-furnished compounds within Viiv.)

This PR touts the fact that ‘572 is the only unboosted qD integrase inhibitor to advance as far as phase-3—the point being that GILD’s Elvitegravir requires PK boosting and MRK’s Isentress is dosed BID. All told, ‘572 looks like a promising compound and a good one for IDIX to have its HIV future hitched to.]

http://finance.yahoo.com/news/ShionogiViiV-Healthcare-prnews-2113635332.html?x=0&.v=1

›Shionogi-ViiV Healthcare Announces Commitment to Phase III Development Program for Investigational Once-Daily HIV Integrase Inhibitor

Source: Shionogi-ViiV Healthcare LLC
Wednesday July 21, 2010, 4:00 am

LONDON, July 21 /PRNewswire/ -- Shionogi-ViiV Healthcare LLC today announced that it will be progressing its once-daily, unboosted investigational integrase inhibitor, S/GSK1349572 ('572) into Phase III clinical trials. '572 will be the only once-daily, unboosted integrase inhibitor in Phase III clinical development.

This decision is based on promising results from two Phase IIb trials, SPRING-1 and VIKING, which are being presented this week at the XVIII International AIDS Conference in Vienna, Austria (Abstract Numbers THLBB205 & MOAB0105). These trials explored the efficacy of '572 in treatment-naive HIV subjects as well as in treatment-experienced subjects resistant to raltegravir. Further study in Phase III is necessary to determine conclusively the safety, efficacy and resistance profile of '572.

"ViiV Healthcare is committed to developing promising new options for the treatment of HIV. As a once-daily, unboosted integrase inhibitor, '572 could be an important new therapy to help people living with HIV," stated Dr. Dominique Limet, Chief Executive Officer, ViiV Healthcare. "'572 has the potential to offer naive and experienced patients a new option, one which in Phase II has shown positive antiviral activity and resistance results once a day. We hope to explore the potential further in the Phase III studies, which are expected to begin this year."

"We are very pleased with the progress of '572 in collaboration with ViiV Healthcare. Reaching the important milestone of initiating Phase III studies is a credit to the hard work and commitment of teams in both Shionogi and ViiV Healthcare. We look forward to starting the Phase III program for '572 and demonstrating its potential to benefit HIV infected patients across the treatment spectrum," said Dr. Sapan Shah, President & CEO, Shionogi Inc.

About the Phase IIb Trials

SPRING-1 Study Design (Abstract THLBB205)

SPRING-1 is an ongoing Phase IIb, multicenter, partially-blinded, dose-ranging study comparing '572 to efavirenz (EFV) in 205 treatment-naive subjects. Individuals were randomized 1:1:1:1 to 10 mg, 25 mg or 50 mg of '572 or EFV 600 mg once daily in combination with either tenofovir/emtricitabine (TDF/FTC) or abacavir/lamivudine (ABC/3TC).

VIKING Study Design (Abstract MOAB0105)

The VIKING study is a Phase IIb multicenter, open-label, single arm study designed to assess the antiviral activity, safety and tolerability of '572 in treatment-experienced, HIV-infected adult subjects with raltegravir (RAL) resistance as short term functional monotherapy, and over a 24-week treatment period with optimized background therapy. Genotypic and phenotypic changes in HIV integrase were also evaluated.

The study enrolled 27 subjects with screening plasma HIV-1 RNA =1000c/mL showing genotypic resistance to RAL and at least two other antiretroviral classes. All subjects had RAL-associated mutations at screening. Subjects received '572 50mg QD while continuing their failing regimen (without RAL) to Day 11 when the background regimen was optimized, where feasible, and '572 continued.

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 IIb clinical development. Shionogi-ViiV Healthcare LLC is also developing second-generation integrase inhibitors, including S/GSK1265744, currently in Phase II development.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established by GlaxoSmithKline (NYSE:GSK) and Pfizer (NYSE:PFE) 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.‹