Atea Pharmaceuticals Reports Positive Proof of Concept Clinical Data With AT-527 for the Treatment of Chronic Hepatitis C
- AT-527 is a novel pan-genotypic purine nucleotide prodrug NS5B polymerase inhibitor which has been safe and well tolerated in this ongoing multiple part trial
- AT-527 exhibits potent antiviral activity in genotype (GT)-1b and GT-3 hepatitis C virus (HCV) infected patients with once-daily (QD) dosing of 550 mg for 7-days
- Preliminary data suggest that AT-527 has potent and equivalent antiviral activity in both cirrhotic and non-cirrhotic (NC) HCV-infected patients
BOSTON, April 12, 2018 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the development of next-generation therapeutics for the treatment of hepatitis C and other single stranded RNA viral infections, today reported positive data from its ongoing clinical trial of AT-527 in patients with GT-1b and GT-3 HCV infection. The company will present the data today at The International Liver Congress(TM) 2018 sponsored by the European Association for the Study of the Liver taking place in Paris, France.
"Although the introduction of new therapies has improved cure rates in recent years, hepatitis C continues to represent a serious global health burden, particularly within more difficult-to-treat patient populations. Given the limitations of currently available agents, we are very excited about the emerging clinical profile of AT-527, a novel, highly differentiated purine nucleotide prodrug, which has an attractive safety profile and very significant antiviral potency. Most notably, preliminary data indicate that AT-527 exhibits potent antiviral activity, regardless of genotype or cirrhosis status in HCV-infected subjects," stated Jean-Pierre Sommadossi, PhD, Atea's Founder, Chairman and Chief Executive Officer.
Poster No. THU-341
Title: AT-527, a pan-genotypic purine nucleotide prodrug, exhibits potent antiviral activity in subjects with chronic hepatitis C
Date/Time: Thursday, April 12, 2018; 9:00 am - 5:00 pm CET
A summary of the data to be presented shows a mean maximum HCV RNA reduction of 2.3 log10 IU/mL after a single dose, and 4.4 log10 IU/mL after 7 days of dosing, of AT-527 in NC GT-1b HCV-infected subjects. A mean reduction of 2.4 log10 IU/mL after first dose and 4.6 log10 IU/mL after 7 days of dosing was achieved in NC GT-3 HCV-infected subjects, respectively. In ongoing cohorts, antiviral activity in Child Pugh A cirrhotic GT-1b/3 HCV infected subjects was similar to NC GT-1b and NC GT-3 cohorts. Emax modeling confirms the clinical observation that 550 mg AT-527 QD will produce maximum efficacy. No serious adverse events, dose-limiting toxicities or premature discontinuations were observed.
About the Trial
The five part study commenced patient enrollment in 2017, and was designed to assess the safety and efficacy of single and multiple doses of AT-527 in healthy and HCV-infected subjects. All HCV-infected subjects were treatment-naïve with HCV RNA greater than or equal to 5 log10 IU/mL. The objectives of the study were to assess safety/tolerability, pharmacokinetics (PK) and antiviral activity.
The trial evaluated single oral doses up to 367 mg (400 mg salt form) in healthy subjects (Part A), single doses up to 550 mg (600 mg salt form) in NC GT-1b HCV-infected subjects (Part B) and multiple doses up to 550 mg once-daily (QD) for 7 days in NC GT-1b HCV-infected subjects (Part C). Ongoing cohorts are evaluating 550 mg QD for 7 days in NC GT-3 (Part D) and Child Pugh A cirrhotic GT-1b/3 (Part E) HCV-infected subjects. Plasma levels of AT-273, the nucleoside metabolite of the active triphosphate, were measured using LC-MS/MS; HCV RNA was quantified using COBAS® AmpliPrep/TaqMan® HCV Test v2.0 with a limit of quantitation (LOQ) of 15 IU/mL.
AT-527, a proprietary investigational agent discovered at Atea, is the salt form of a purine nucleotide prodrug NS5B polymerase inhibitor. Unique structural modifications of AT-527 result in differentiated pharmacologic and antiviral properties as compared to other anti-HCV nucleotides. AT-511, the free base of AT-527, showed potent antiviral activity in vitro against wild-type clinical isolates with EC95 values less than 80 nM in all HCV genotypes, and demonstrated about 10- to 14-fold more potency than sofosbuvir (SOF) in GT-1 and GT-3 replicons. AT-511 maintained activity against SOF-resistant S282T single and S282T/L159F double variants, with about 50-fold greater potency than SOF.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and transplants. According to the World Health Organization, over 70 million people suffer from chronic hepatitis C. Direct-acting antiviral agents (DAAs) have markedly improved the prognosis of many patients infected with the hepatitis C virus and allow the achievement of a cure in 8 - 12 weeks in select patient populations. Further shortening of the treatment duration in those patients and extending it to more difficult-to-treat HCV patient populations continues to be a sought-after goal of the biotech and pharma industry. Global sales of DAAs for the treatment of HCV infection were $12.5 billion in 2017.
Atea Pharmaceuticals is a clinical stage biopharmaceutical company engaged in the discovery and development of proprietary and novel therapeutics for the treatment of hepatitis C and other single stranded RNA viral infections. Atea was founded in 2013 by its Chairman and Chief Executive Officer Jean-Pierre Sommadossi, PhD, and is headquartered in Boston, MA.
Andrea J. Corcoran
Investors and Media:
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Atea Pharmaceuticals, Inc. via Globenewswire
Om Nasdaq GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York
+1 212 401 8700http://www.nasdaqomx.com
NASDAQ (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.
Følg saker fra Nasdaq GlobeNewswire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Nasdaq GlobeNewswire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Nasdaq GlobeNewswire
Williams Scotsman to Announce First Quarter 2018 Results on May 3, 201824.4.2018 21:59 | Pressemelding
BALTIMORE, April 24, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (NASDAQ:WSC) ("Williams Scotsman") today announced that it will release its first quarter 2018 financial results on Thursday, May 3, 2018, after the markets close. President and Chief Executive Officer Bradley Soultz, and Chief Financial Officer Timothy Boswell will host a conference call and webcast on Friday, May 4, 2018, at 10:00 a.m. EDT to discuss the results for the first quarter. The live call can be accessed by dialing (855) 312-9420 (U.S./Canada toll-free) or (210) 874-7774 (international). A live webcast will also be accessible via the "Events & Presentations" section of the Company's Investor Relations website https://investors.willscot.com. An archived version of the webcast will be available for 60 days following the call. About WillScot Corporation Headquartered in Baltimore, Maryland, WillScot Corporation is the public holding company for the Williams Scotsman family of companies in the United States, Can
Nasdaq Announces Results from 2018 Annual Meeting of Stockholders24.4.2018 20:00 | Pressemelding
Jacob Wallenberg, New Director, Elected to the Board and Nine Directors Re-elected Nasdaq Board Re-elects Michael R. Splinter as Chairman of the Board NEW YORK, April 24, 2018 (GLOBE NEWSWIRE) -- Nasdaq, Inc. (Nasdaq:NDAQ) stockholders today elected all nominated directors at the company's Annual Meeting of Stockholders. All directors will serve one-year terms. Elected board members include: Melissa M. Arnoldi, President of Technology & Operations, AT&T Communications Charlene T. Begley, Retired SVP & CIO, General Electric Company Steven D. Black, Co-CEO, Bregal Investments Adena T. Friedman, President and CEO, Nasdaq Essa Kazim, Governor, Dubai International Financial Center and Chairman, Borse Dubai and Dubai Financial Market Thomas A. Kloet, Retired CEO & Executive Director, TMX Group Limited John D. Rainey, CFO and EVP of Global Customer Operations, PayPal Holdings, Inc. Michael R. Splinter, Retired Chairman and CEO, Applied Materials, Inc. Jacob Wallenberg, Chairman, Investor AB L
Inspiration Updates Proposed Acquisition of Compassion Cannabis24.4.2018 17:00 | Pressemelding
TORONTO, April 24, 2018 (GLOBE NEWSWIRE) -- Inspiration Mining Corporation (CSE:ISM) (the "Corporation") is pleased to announce that its ongoing negotiations with Compassion Cannabis Corp ("Compassion") and the related due diligence is going very well and ahead of the targeted date. The Corporation has commenced discussions pertaining to the terms and conditions of a proposed share exchange agreement and the resulting structure of the Corporation's board of directors. Compassion is a private Ontario company which has expertise to forward various facets of the explosive new market of the marijuana industry, including but not limited to the "Vape" market and dispensary centers for the industry. The Corporation believes that this is an extremely lucrative space with tremendous demand in the medical cannabis industry. The cannabis market is growing exponentially every day with new and exciting innovations in the industry. Compassion has narrowed down its possible research and development l
Barings Supports Liberty Hall on Refinancing of AIM Aerospace24.4.2018 16:00 | Pressemelding
CHARLOTTE, N.C., April 24, 2018 (GLOBE NEWSWIRE) -- Barings, one of the world's leading financial services firms, announced today that it served as the sole agent and lead arranger on first lien senior credit facilities to support Liberty Hall Capital Partners' refinancing of the existing debt of its portfolio company, AIM Aerospace. AIM Aerospace, based in Renton, Washington, is a leading designer and producer of advanced composite structures, systems, engine components and thermoplastic technology for the global aerospace industry. The company supplies thermoset and thermoplastic composite solutions to Tier 1 aero-structure and aero-equipment suppliers and to aircraft original equipment manufacturers (OEMs). "Liberty Hall appreciates the partner-like approach that Barings brought to support our investment in AIM Aerospace," said Rowan Taylor, Liberty Hall's founding Partner. "Barings' creativity in structuring, ability to move quickly and speak for the entire facility helped expedite
Appian Announces Strategic Technology Alliance with Genesys24.4.2018 15:04 | Pressemelding
Companies align development, marketing, and sales to deliver intelligent case management for contact center excellence RESTON, Va., April 24, 2018 (GLOBE NEWSWIRE) -- Appian (NASDAQ:APPN) today announced a strategic technology alliance with Genesys®, the global leader in omnichannel customer experience and contact center solutions. The partnership will benefit organizations seeking next-generation customer engagement solutions that integrate the case management, intelligent automation, and low-code application development capabilities of Appian with the Genesys Customer Experience Platform. "Over the last several years, Serco has used Appian technology, alongside Genesys, to deliver contact solutions to its Federal customers, having processed tens of millions of cases across thousands of contact center agents through our systems. We are excited to hear about the tighter technology partnership between Appian and Genesys as it opens up the possibility to deliver more efficient solutions
Appian and KPMG Apply Artificial Intelligence to Create Business Value24.4.2018 15:03 | Pressemelding
Appian's low-code development platform operationalizes KPMG machine learning experience RESTON, Va., April 24, 2018 (GLOBE NEWSWIRE) -- Appian (NASDAQ:APPN) and KPMG LLP today announce an expansion of their strategic alliance. Together, the companies are focused on making it easier to realize the business value of artificial intelligence (AI) by combining the KPMG Ignite portfolio of AI services with the speed, features, and intelligent automation (IA) capabilities of Appian's low-code platform. KPMG and Appian will expand their relationship around AI-related applications, and Appian's platform will be leveraged by KPMG Lighthouse, a Center of Excellence for Data & Analytics, to demonstrate application and operational delivery of innovative AI services. AI technology holds immense promise for smarter decisions, faster action, and smoother business operations in scenarios ranging from frontline customer service to back-office risk management and regulatory compliance. Real-world deploym
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom