Odalasvir (also known as ACH-3102) by Achillion Pharmaceuticals is an pan-genotypic NS5A inhibitor to treat chronic Hepatitis C.
Janssen has initiated phase IIb study of simeprevir, odalasvir and AL-335
The objectives of the phase IIb study are to investigate the efficacy, safety and pharmacokinetics of JNJ-4178/ AL-335 (800mg QD), odalasvir (25mg QD), and simeprevir (75mg QD) in treatment-naive and treatment-experienced non-cirrhotic subjects with chronic hepatitis C virus genotype 1, 2, 4, 5, and 6 infection.
Nov 13 2016
Once-Daily Simeprevir, AL-335, and Odalasvir Combination Safe, Effective
By Bryant Furlow November 13, 2016
BOSTON, MA—Once-daily-administered combination of the investigative direct-acting antivirals AL-335 and odalasvir (ODV), and simeprevir (SMV) is well tolerated in healthy volunteers, and is now under study among patients with hepatitis C virus (HCV), according to findings from an open-label Phase 1 study presented at The Liver Meeting® 2016.
EASL/AASLD2016 - Achillion Reports 100% SVR In Phase2a Trial:Odalasvir, AL-335, and Simeprevir for Geno 1 Treatment-Naïve
New data released today in abstract for upcoming EASL / AASLD Special Conference: New Perspectives in Hepatitis C Virus Infection – The Roadmap For Cure -
- Janssen advancing triple combination into Phase 2b clinical trial -
NEW HAVEN, Conn., Sept. 09, 2016 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) announced today that new interim results from a phase 2a study being conducted by Alios BioPharma, Inc., part of the Janssen Pharmaceutical Companies (Janssen), were published as part of the abstracts released for the upcoming European Association for the Study of the Liver (EASL) Special Conference, September 23 - 24, 2016, in Paris, France.
Achillion, J&J's HCV Combo Drug Positive in Phase IIa Trial
Achillion Pharmaceuticals, Inc announced positive interim results from a phase IIa study on an all-oral triple combination of AL-335, odalasvir (also known as ACH-3102) and Johnson & Johnson's Olysio (simeprevir) for the treatment of patients suffering from genotype 1 chronic hepatitis C virus (HCV) infection.
In Jun 2015, Achillion outlicensed its HCV portfolio to Johnson & Johnson. Under the agreement, J&J has global rights to develop and commercialize one or more of Achillion's lead HCV candidates, including ACH-3102, ACH-3422 and sovaprevir.
The phase II study is being conducted by Alios BioPharma, Inc., part of a Johnson & Johnson subsidiary, Janssen. Note that AL-335 is a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir an HCV NS5A inhibitor and Olysio an HCV NS3/4A protease inhibitor.
The phase 2a study was designed to determine pharmacokinetics, efficacy and safety of odalasvir and AL-335, with or without simeprevir.
Cohort 1 consisted of 20 patients who received the triple combination of once-daily odalasvir (50mg), AL-335 (400mg) and simeprevir (100mg) for eight weeks. Interim results from the phase IIa study showed that 100% patients in cohort 1 remained HCV RNA-undetectable at 24 weeks after completing therapy. The phase IIa study also confirmed the required dose for each component and treatment duration.
The all-oral combination regimens, containing odalasvir, AL-335, with or without simeprevir, were well tolerated with no serious adverse events.
Interim results from phase IIa study were published as part of the abstracts released for the upcoming European Association for the Study of the Liver (EASL) Special Conference, Sep 23-24, in Paris, France.
Based on the interim results of the phase II study, Janssen plans to initiate a global phase IIb study on both treatment-naïve and treatment-experienced patients with genotypes 1-6 HCV, including patients with or without cirrhosis.
Achillion's collaboration with Johnson & Johnson for the HCV portfolio makes sense given the latter's expertise in development and commercialization capabilities. Moreover, the deal could see Achillion receiving up to $1.1 billion in the form of development, regulatory and sales milestone payments, apart from a separate equity investment. Achillion is also entitled to receive tiered royalties in the mid teens to low twenties on future worldwide sales. All development and commercialization costs will be borne by Johnson & Johnson.
Medivir (MVRBF): Updated Interim Phase IIa Data Demonstrate That The Combination Of Simeprevir, Odalasvir And AL-335 Has A High Level Of Efficacy In HCV Patients
“Short duration treatment with AL-335 and odalasvir (ODV), with or without simeprevir (SMV), in treatment naïve patients with hepatitis C virus (HCV) genotype (GT) 1 infection.”Medivir AB (STO:MVIRB) today announced that updated interim data from a phase IIa study being conducted by Alios BioPharma Inc., part of the Janssen Pharmaceutical Companies (Janssen), were presented on September 23rd at the European Association for the Study of the Liver (EASL) Special Conference in Paris, France.
The updated results, which include expanded safety and efficacy data, were presented in the ePoster entitled "Short duration treatment with AL-335 and odalasvir (ODV), with or without simeprevir (SMV), in treatment naïve patients with hepatitis C virus (HCV) genotype (GT) 1 infection." The data show that 100 percent of patients receiving treatment for as short as six weeks with a triple combination of once-daily (QD) simeprevir 75mg and AL-335 800mg with 50mg every other day (QOD) of ODV achieved a sustained viral response 12 weeks after the completion of treatment (SVR12)
Janssen to Start a Phase IIb Study/Combinations of Simeprevir, Odalasvir and AL-335 for the Treatment of Hepatitis C
Medivir AB (STO:MVIRB) today announces that Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies (Janssen), has decided to initiate a phase IIb study to investigate the efficacy, safety and pharmacokinetics of different treatment regimens of AL-335, odalasvir, and simeprevir in treatment-naïve and treatment-experienced patients with chronic Hepatitis C Virus (HCV) genotype 1-6 infection, with and without cirrhosis.
This global phase IIb study is a randomized, open-label, four-arm study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor, odalasvir, an HCV NS5A inhibitor and simeprevir, an HCV NS3/4A protease inhibitor. Approximately 400 patients will be randomized to one of four treatment arms and receive once daily treatment for a duration of six or eight weeks. Patients in two of the four arms will receive AL-335, odalasvir and simeprevir, a compound jointly developed by Janssen Sciences Ireland UC and Medivir AB, while patients in the other two arms will receive only AL-335 and odalasvir. The primary endpoint of the study is the percentage of chronic HCV-infected subjects who achieve a sustained virologic response 12 weeks after the end of treatment (SVR12). The study is intended to start in June 2016 and the estimated date for completion is July 2017.
Further information about the study can be found at www.clinicaltrials.gov.
Study identifier: NCT02765490.
Sept 17 2015
Achillion Reports 100% SVR12 From Second Cohort of Patients in the Previously-Completed Six Week Phase 2 Trial Evaluating Odalasvir (ACH-3102) and Sofosbuvir for Genotype 1 HCV ("Proxy Study")
- 100% SVR12 reported for all patients treated for six- (n=18) or eight-weeks (n=12)
- Odalasvir (ACH-3102) is the subject of an exclusive, worldwide development and commercialization license granted to Janssen
April 25 2015
Achillion Presents Detailed Clinical Results on ACH-3102 and ACH-3422 at the International Liver Congress
-Two late breaker presentations detail previously announced 100% SVR12 in Phase 2 trial evaluating 6- or 8-weeks of treatment with ACH-3102 and sofosbuvir in genotype 1 HCV patients
-Phase 1 proof-of-concept results with ACH-3422
- Clinical virology presentation continues to support improved barrier to resistance with ACH-3102 -
"We believe that the ability to achieve 100% SVR12 after six-weeks of treatment with ACH-3102 and sofosbuvir supports the potential for our proprietary doublet regimen to reduce treatment duration for HCV patients," commented Milind Deshpande, Ph.D., President and Chief Executive Officer of Achillion. "We are also very pleased with the robust Phase 1 proof-of-concept data reported on ACH-3422, our proprietary NS5B nucleotide polymerase inhibitor, and the clinical virology presentation that continues to support the differentiated higher barrier to resistance for ACH-3102."
Feb 9 2015
Achillion's NS5A inhibitor, ACH-3102, and Gilead's Sovaldi ;
Achillion, Gilead drug cocktail cures hepatitis C in six weeks
- Achillion achieves 100% SVR12 in six-week regimen with combination of ACH-3102 and sofosbuvir for treatment-naïve genotype 1 HCV -
- Achillion to initiate 4-week treatment regimens based on the strength of ACH-3102 antiviral data -
Achillion Data Shows Promise of Shorter-Duration Hep C Treatment
By Natalie Grover
December 23, 2014
(Reuters) - Data from Achillion Pharmaceuticals Inc's hepatitis C drug trials showed the company could develop a shorter-duration treatment rivaling offerings from Gilead Sciences Inc and Abbvie Inc.
The company said on Monday it would test a combination of two of its experimental hepatitis C drugs after they showed promise against the virus in separate studies.
Data from the first study, testing a combination of Achillion's NS5A inhibitor, ACH-3102, and Gilead's blockbuster Sovaldi, showed signs that the virus disappeared within four weeks, following a six-week course of therapy.
Gilead's Harvoni, which combines Sovaldi with the company's own NS5A inhibitor, achieves this response only after eight weeks of therapy.
The main goal of Achillion's ongoing mid-stage study is to achieve a sustained virological response 12 weeks after therapy that would constitute a cure.
The market for hepatitis C drugs has developed at a lightening pace in recent years, with several companies working on producing newer drugs to treat the disease that affects about 150 million around the world. The U.S. health regulator on Friday approved Abbvie's hep C cocktail.
In a separate early-stage study, Achillion's nucleotide inhibitor, ACH-3422, also demonstrated potent antiviral activity.
William Blair's Katherine Xu said the company's ACH-3422 was slower to exert its effects than Sovaldi, adding that its nucleotide inhibitor needs to be equally effective for Achillion to attract takeover interest.
Achillion, one of the few companies developing hepatitis C drugs independently, said it planned to start mid-stage studies to evaluate the combination next year.
Wells Fargo's Brian Abrahams said an all-Achillion combination could still have an edge over competition as ACH-3102's high barrier to resistance will offset ACH-3422's slower effect.
Aug 15 2014
Achillion's hepatitis C drug shows promise in trial
The mid-stage trial tested Achillion's drug, ACH-3102, in 12 patients in combination with Gilead Sciences Inc's Sovaldi, also known as sofosbuvir. Achievement of 100 percent cure rate confirms the competitive profile of NS5A, Wells Fargo Securities analyst Brian Abrahams wrote in a note.
April 25 2013
EASL: Achillion Presents New Data on ACH-3102 to Treat Hepatitis C
Achillion Initiates Phase 2 Interferon-Free Trial of Sovaprevir and ACH-3102 for Genotype 1 HCV
Jan 7 2013
Hepatitis C - Achillion Reports Interim Results on ACH-3102
Enrollment completed in pilot Phase 2a study of ACH-3102 and ribavirin for genotype 1b CC patients -
- Up to 12 weeks of once daily ACH-3102 appears safe and well tolerated with no on-treatment virologic breakthrough
observed to date -
- Profile of ACH-3102 supportive of continued development for genotype 1b and in combination with other direct-acting
antivirals for the broad treatment of HCV -
AASLD-Achillion Programs: Sovaprevir, ACH-3102 and ACH-2684
Achillion Pharmaceuticals moves up as a contender in the HCV market
ACH-3102-Achillion Announces Positive Proof-of-Concept Data
Achillion Pharma strikes deal to raise $41.8M as hep C results loom
Hepatitis C-ACH-3102 Receives Fast Track Designation From the FDA
Achillion Pan-Genotypic ACH-3102 begins dosing in a Phase 1 clinical trial
Achillions Announces Second Generation NS5A Inhibitor -ACH-3102