Gilead Announces Positive Phase 2 Results for GS-9674 in Primary Sclerosing Cholangitis (PSC) at The Liver Meeting® 2018
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that treatment with GS-9674, an investigational, selective, nonsteroidal farnesoid X receptor (FXR) agonist, led to significant improvements in liver biochemistry and markers of cholestasis in patients with primary sclerosing cholangitis (PSC). Data were presented at The Liver Meeting® 2018 in San Francisco.
PSC is a rare, chronic condition that causes the network of ducts that drain bile from the liver to become inflamed and scarred over time. Progressive damage to the bile ducts in patients with PSC can lead to cirrhosis, liver failure, and cholangiocarcinoma (cancer of the bile ducts). Fatigue, pruritus and abdominal discomfort are common symptoms of PSC that can greatly impact patients’ quality of life. There are no approved treatments for PSC.
“Gilead is committed to applying our research expertise in liver disease to address this debilitating condition which may lead to serious liver-related complications for PSC patients,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “These latest results from our Phase 2 program of GS-9674 are a positive step forward in the search for effective therapy.”
In the Phase 2, double-blind, placebo-controlled trial, 52 non-cirrhotic patients with PSC were randomized to receive GS-9674 100 mg (n=22), GS-9674 30 mg (n=20), or placebo (n=10) orally once daily for 12 weeks. After 12 weeks of treatment, patients receiving GS-9674 100 mg demonstrated significant improvements in liver biochemistry tests, with a median reduction in serum alkaline phosphatase (ALP) of 20.5 percent vs. an increase of 3.4 percent with placebo (p=0.029), median reduction in gamma-glutamyl transferase (GGT) of 30.3 percent vs. an increase of 1.1 percent with placebo (p<0.001), median reduction in alanine aminotransferase (ALT) of 49.4 percent vs. 12.9 percent with placebo (p=0.009), and a median reduction in aspartate aminotransferase (AST) of 42.3 percent vs. 10.8 percent with placebo (p=0.019). In both groups treated with GS-9674, reduced serum levels of C4, an intermediate in the synthesis of bile acids, were observed compared with placebo (-23.2 percent in the 100 mg group, p=0.21; and -30.5 percent in the 30 mg group, p=0.024). Reductions in serum bile acids were greatest with the 100 mg dose.
GS-9674 was well tolerated and the incidence of Grade 2 or 3 pruritus was numerically lower with GS-9674 100 mg (13.6 percent) and 30 mg (20 percent) compared with placebo (40 percent). There were no elevations in serum lipids. Treatment was discontinued due to adverse events in three patients treated with GS-9674 100 mg (14 percent), including one discontinuation due to pruritus, and one patient with placebo (10 percent).
A separate analysis of health-related patient-reported outcome measures (PROs) among patients enrolled in the Phase 2 trial demonstrated significant impairment of PRO scores among PSC patients with pruritus or fatigue. In the evaluation, patients treated with GS-9674 100 mg experienced significant improvement of the Primary Biliary Cholangitis – 40 (PBC-40) Emotional score (p=0.04) compared with patients treated with placebo.
“Patients living with PSC urgently need effective and tolerable treatment options,” said Michael Trauner, MD, presenting author and Head of the Division of Gastroenterology and Hepatology at the Medical University of Vienna, Austria. “These Phase 2 results are encouraging in terms of beneficial changes in liver biochemistry, markers of bile acid homeostasis, and patient-reported outcome measures. We look forward to further determining the safety and efficacy of this investigational agent.”
GS-9674 is an investigational compound and is not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Its safety and efficacy have not been determined.
GS-9674 is an investigational, selective, non-steroidal agonist of the farnesoid X receptor (FXR), a nuclear hormone receptor that is highly expressed in the gastrointestinal tract and liver. FXR is the primary regulator of bile acid synthesis and plays important roles in glucose and lipid metabolism. GS-9674 is being investigated for the treatment of PSC, primary biliary cholangitis (PBC), and advanced fibrosis due to nonalcoholic steatohepatitis (NASH), a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring or fibrosis. GS-9674 is an investigational agent and its efficacy and safety have not been determined.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to complete the clinical trial programs evaluating GS-9674 for the treatment of primary sclerosing cholangitis in the currently anticipated timelines, or at all. In addition, there is the possibility of unfavorable results from additional clinical trials involving GS-9674. Further, it is possible that Gilead may make a strategic decision to discontinue development of GS-9674, and as a result, GS-9674 may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000
Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Arran Attridge, 650-425-8975
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Proteus Digital Health® Founder to Present at World Economic Forum in Davos21.1.2019 18:54 | Pressemelding
Proteus Digital Health® announced today that Andrew Thompson, its President, Chief Executive Officer and Co-Founder, will present on the progress of Proteus’ digital medicines to improve patient treatment and outcomes at the 2019 World Economic Forum Annual Meeting in Davos-Klosters, Switzerland. Mr. Thompson will present on the official programme: With leaders from financial and academic institutions to address “Theory of the Firm in a World of Digital Ecosystems,” on Tuesday, January 22 beginning at 9:45 a.m. CET in the Congress Centre, Jakobshorn; and Joining state and religious leaders in the Open Forum “Bridging Science with Society,” scheduled to begin at 9:00 a.m. CET on Friday, January 25 at the Swiss Alpine High School Auditorium. This session will be live-streamed on TopLink and the Forum website. Mr. Thompson will also present at two other events during the World Economic Forum Meeting: January 22 at 8:05 p.m., Polish House: Mr. Thompson will provide a keynote address on the
CNIM Is to Equip the French Navy with 14 New Standard Amphibious Landing Craft (EDA-S)21.1.2019 18:36 | Pressemelding
CNIM - in partnership with Socarenam, Mauric and CNN MCO - has been awarded the contract to replace the French Navy's landing crafts. Fourteen new Standard Amphibious Landing Crafts (EDA-S) are to be built over a ten-year period. This contract reasserts CNIM's status as a key partner to the French Navy and a European leader in the area of amphibious operations, supplying the complementary innovative vessels: EDA-S and EDA-R (already in service in the French Navy, designed by CNIM). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190121005420/en/ CNIM is to equip the French Navy with 14 new Standard Amphibious Landing Craft (EDA-S) - (c) CNIM Next-generation of vessels designed by CNIM "Winning this European tender reasserts CNIM's status as experts in amphibious craft design. CNIM is to replace the French Navy's existing landing craft with fourteen new Standard Amphibious Landing Craft, also called EDA-S", notes Philippe Demi
Naspers Progresses Plans to List MultiChoice Group Limited and Unbundle Its Shares in MultiChoice Group to Naspers Shareholders21.1.2019 16:04 | Pressemelding
On 17 September 2018, Naspers Limited (JSE: NPN; LSE: NPSN) announced its intention to list its video entertainment business separately on the Johannesburg Stock Exchange (JSE) as MultiChoice Group Limited (MultiChoice Group) and simultaneously unbundle its shares in this business to Naspers shareholders. It is expected that the Admission and dealings in the Shares will commence on Wednesday, 27 February 2019. In relation to the Admission, MultiChoice Group today published a pre-listing statement compliant with the requirements of the JSE. MultiChoice South Africa (MCSA), MultiChoice Africa, Showmax and Irdeto and their subsidiaries and affiliates, will, among others, be subsidiaries of MultiChoice Group. MultiChoice Group is the leading video entertainment operator on the African continent, with an extensive local and international content offering. It is one of the fastest-growing pay-TV broadcast providers globally and provides entertainment to around 14 million households across 50
MultiChoice Group Limited (MCG) Today Released Its Pre-Listing Statement in Compliance with the JSE Listings Requirements21.1.2019 15:59 | Pressemelding
Naspers Limited (JSE: NPN; LSE: NPSN) : MultiChoice Group Limited (MCG) today released its pre-listing statement in compliance with the JSE Listings Requirements (www.multichoice.com) providing further details about its listing on the Johannesburg Stock Exchange (JSE). Trading in MCG shares is expected to commence on the JSE on Wednesday, 27 February 2019. As announced on 17 September 2018, MCG will include, amongst others, MultiChoice South Africa (MCSA), MultiChoice Africa, Showmax, as well as the global digital platform security provider, Irdeto and all their subsidiaries and affiliates (“the Group”). Calvo Mawela, Group Chief Executive Officer of MCG said: “We believe the listing of MultiChoice provides an excellent opportunity to invest in the leading provider of video entertainment on the African continent. MCG brings an incomparable local and international content offering to around 14-million households and is one of the fastest growing pay-TV broadcast providers globally. With
ResMed’s First Top-of-Head CPAP Mask, AirFit N30i, Now Available across U.S.21.1.2019 14:05 | Pressemelding
ResMed (NYSE: RMD, ASX: RMD), today introduced AirFit N30i, its first top-of-head-connected nasal CPAP mask, across the United States, with a newly designed nasal cradle cushion that sits just under the wearer’s nose. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190121005035/en/ AirFit N30i nasal CPAP mask, front view (Photo: Business Wire) The top-of-head connection keeps tubing out of the wearer’s way, letting them move and sleep in any position. The nasal cradle cushion – ResMed’s first – is designed to reduce facial markings and irritation. AirFit N30i is also convenient for equipment providers and sleep labs – it fits 96 percent of PAP users with just two frame sizes and four cushion sizes. How AirFit N30i compares to the market-leading nasal top-of-head mask In side-by-side comparisons, three out of four users preferred AirFit N30i over the other nasal mask with a top-of-head connection. A majority stated they loved
Metabolon Appoints Michael Rasche as President of International Business21.1.2019 13:06 | Pressemelding
Metabolon, the world leader in metabolomics, today announced that Michael Rasche joined the company as President of International Business. Michael will report to Rohan Hastie, Metabolon’s President and CEO, and become a member of the corporate executive team. He will lead all of Metabolon's international business activities with a strong focus on customer and team expansion. "We are thrilled to have Michael join the Metabolon team," said Hastie. "Michael brings a wealth of commercial and business experience across multiple areas of life sciences, from Pharma to Diagnostics and Biotech. I know he will make an immediate impact on our existing and future customers." "I am very excited to become part of the Metabolon success story," added Rasche. "I will passionately lead our team to drive accelerated business expansion across all international markets. Our Precision Metabolomics™ technology is delivering biomarker discoveries, innovative diagnostic tests, and groundbreaking data in genom