NASDAQ OMX

Atea Pharmaceuticals Reports Positive Proof of Concept Clinical Data With AT-527 for the Treatment of Chronic Hepatitis C

Dela
  • 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.

About AT-527

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. 

About Atea
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.

Contact:

Company:
Andrea J. Corcoran
617-669-4272
corcoran.andrea@ateapharma.com

Investors and Media:
Constantine Davides
Westwicke Partners
Tel: 339-970-2846
constantine.davides@westwicke.com




This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
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 OMX
NASDAQ OMX



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

Immunicum AB (publ) Announces Appointment of Pawel Kalinski and Inge Marie Svane to Scientific Advisory Board17.9.2018 08:00Pressmeddelande

Press Release 17 September 2018 Immunicum AB (publ) Announces Appointment of Pawel Kalinski and Inge Marie Svane to Scientific Advisory Board Immunicum AB (publ; IMMU.ST) announced today the appointment of leading oncology experts to its Scientific Advisory Board with the addition of Pawel Kalinski, MD, PhD, Vice Chair for Translational Research within the Department of Medicine at Roswell Park Comprehensive Cancer Center, and Inge Marie Svane, MD, PhD, Professor, Head of the Clinical Cancer Research programme, Faculty of Health Sciences, University of Copenhagen, Director, Centre for Cancer Immunotherapy (CCIT), and consultant in Oncology, Herlev University Hospital. Both Scientific Advisory Board members will serve as a strategic resource to Immunicum as the company continues to advance the clinical development of its lead product, ilixadencel. "We are honored to have such highly specialized experts in the field of immuno-oncology and cell therapy join our Scientific Advisory Board a

Immunicum AB (publ) meddelar att Pawel Kalinski och Inge Marie Svane har valts in i det vetenskapliga rådet17.9.2018 08:00Pressmeddelande

Pressmeddelande 17 september 2018 Immunicum AB (publ) meddelar att Pawel Kalinski och Inge Marie Svane har valts in i det vetenskapliga rådet Immunicum AB (publ; IMMU.ST) meddelade i dag att två ledande immun-onkologiska experter har valts in i bolagets vetenskapliga råd för att fungera som strategiska resurser för Immunicum under bolagets fortsatta kliniska utveckling av sin ledande produkt, ilixadencel. Pawel Kalinski, MD, PhD, vice ordförande för translationell forskning vid den medicinska institutionen vid Roswell Park Comprehensive Cancer Center, och Inge Marie Svane, MD, PhD, professor, chef för det kliniska cancerforskningsprogrammet på medicinska fakulteten vid Köpenhamns universitet, chef för Center för cancerimmunterapi (CCIT) samt överläkare inom onkologi, Herlevs universitetssjukhus har valts in i rådet. - Vi är hedrade att ha experter med specialistkompetens inom området immunonkologi och cellterapi i vårt vetenskapliga råd, vilka kan erbjuda ytterligare vägledning när det

Hoylu AB: HOYLU HIRES NEW CTO, SATOSHI NAKAJIMA AND ANNOUNCES EXPANSION INTO JAPAN14.9.2018 08:30Pressmeddelande

Malmo, Sweden, September 14, 2018 - Hoylu, a leading enterprise collaboration company, announced today Satoshi Nakajima will join Hoylu in the newly created position, as Chief Technology Officer and President of Hoylu Japan. Nakajima will guide the strategic technology direction and innovation of Hoylu while also leading the new Hoylu office in Tokyo, Japan. "Satoshi is a visionary and world-class technologist who has substantial experience in delivering world class innovations. He is joining the Company as we are extending our reach and expanding into Japan," said Stein Revelsby, CEO. "Satoshi's extensive experience in strategy and delivering technology that support a great user experience will make an immediate impact on the company." Nakajima will serve as President of Hoylu Japan and will report to Stein Revelsby. His leadership will strengthen customer relations and help develop new business among emerging and established Japanese companies while strengthening the global position

Hoylu AB: HOYLU ANSTÄLLER SATOSHI NAKAJIMA SOM NY CTO OCH EXPANDERAR TILL JAPAN14.9.2018 08:30Pressmeddelande

Malmö, Sverige, 14 september 2018 - Hoylu, ett ledande företag inom samarbetsmjukvara för företagsmarknaden annonserar idag att Satoshi Nakajima tar anställning som CTO (Chief Technology Officer) och President för Hoylu Japan. Nakajima kommer styra den strategiska inriktningen för företagets produkter och leda innovationsarbetet. Han kommer också leda Hoylus nyöppnade kontor i Tokyo, Japan. Satoshi är en visionär teknologiexpert som har stor erfarenhet av att skapa innovativa lösningar. Han kommer till Hoylu samtidigt som vi utökar marknaden till att även täcka in Japan säger Stein Revelsby, VD. "Satoshis långa och gedigna erfarenhet i strategiska frågor och tekniska lösningar med fokus på användarupplevelse kommer få stor betydelse för oss." Nakajima kommer även att bli President för Hoylu Japan och kommer rapportera till Stein Revelsby. Hans ledarskap kommer stärka existerande kundrelationer och utveckla nya affärer på den japanska marknaden och samtidigt bidra till att flytta fram p

LeoVegas AB: LeoVentures invests in esports betting - Pixel.bet13.9.2018 08:45Pressmeddelande

The LeoVegas Group, through its wholly owned investment company LeoVentures Ltd, has acquired 51% of the shares in Pixel Holding Group Ltd, which runs the esports betting operator Pixel.bet. The investment amounts to EUR 1.5 million for 51 percent of the company and is made through a new issue. Pixel.bet's vision is to create the greatest gaming experience in betting on esports www.pixel.bet "Esports is an international and fast-growing area that engages millions of viewers and players every month. With this investment in Pixel.bet we as a Group will gain unique insight into a new and fast-growing segment," comments Gustaf Hagman, LeoVegas' Group CEO and co-founder of LeoVegas Mobile Gaming Group. "In Pixel.bet we have found a passionate team of entrepreneurs who come from the esports community. With its strong technology and mobile-first gaming experience, Pixel.bet is a perfect match for the LeoVegas Mobile Gaming Group. Together we will drive development for the absolute premier exp

LeoVegas AB: LeoVentures investerar i esport betting - Pixel.bet13.9.2018 08:45Pressmeddelande

LeoVegas-koncernen har, genom sitt helägda investmentbolag LeoVentures Ltd förvärvat Pixel Holding Group Ltd, som driver esport betting operatören pixel.bet. Investeringen uppgår till 1,5 miljoner euro för 51 procent av bolaget och görs genom en nyemission. Pixel.bets vision är att skapa den främsta spelupplevelsen inom betting på esport www.pixel.bet "Esport är ett internationellt och snabbt växande område som engagerar miljontals tittare och utövare varje månad. Med investeringen i Pixel.bet får vi som koncern en unik inblick i ett nytt och snabbt växande segment.", säger Gustaf Hagman, Group CEO och co-founder av LeoVegas Mobile Gaming Group. "I Pixel.bet fann vi ett passionerat entreprenörsteam som verkligen kommer inifrån esport communityn. Med en riktigt bra teknik och spelupplevelse utvecklad mobile-first är det en perfekt match med LeoVegas Mobile Gaming Group. Tillsammans ska vi driva utveckling för den absolut främsta upplevelsen inom esport betting.", säger Robin Ramm-Ericso

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum