odalasvir (ACH-3102) / J&J, AstraZeneca - LARVOL DELTA

Drug-Drug Interactions between Direct Oral Anticoagulants and Hepatitis C Direct-Acting Antiviral Agents: Looking for Evidence Through a Systematic Review. (PubMed, Clin Drug Investig) - "DOACs and DAAs are under-investigated for DDI risk. Real-world studies are needed to assess the clinical relevance of the pharmacokinetic interactions with dabigatran and describe the actual spectrum of possible DDIs between DAAs and other DOACs."

Journal • Review • Hepatitis C Virus • Infectious Disease

[VIRTUAL] Drug-Drug Interactions between Direct Oral Anticoagulants and Hepatitis C Direct-Acting Antiviral Agents: A Systematic Review (ISTH 2020) - "Three were phase 1 clinical studies in healthy volunteers, each assessing interactions between dabigatran and glecaprevir/pibrentasvir or odalasvir/simeprevir or sofosbuvir/velpatasvir/voxilaprevir. DAAs increase dabigatran concentration, as predicted from pharmacokinetics. Real world studies are needed to assess clinical relevance of this interaction and describe actual spectrum of possible DDI between DAAs and other DOACs."

Review • Atrial Fibrillation • Cardiovascular • Hepatitis C Virus • Infectious Disease • Venous Thromboembolism • CYP3A4

JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-infected Patients without Cirrhosis: OMEGA-1. (PubMed, Hepatology) - P2b | "This multicenter, randomized, open-label study (NCT02765490) enrolled treatment-naïve and interferon (±ribavirin) treatment-experienced patients with HCV GT1, 2, 4, 5, or 6 infection. All randomized patients completed treatment. In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9% and 97.8%, respectively, and was well tolerated."

Clinical • Journal • Fibrosis • Hepatitis C Virus • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis

Achillion reports 2013 fourth quarter and year-end financial results (Achillion Press Release) - Anticipated completion of P1 drug-drug interaction study evaluating ACH-3102 and ACH-2684 in Q2 2014; Anticipated initiation of P2 trial evaluating ACH-3102 with ACH-2684 in Q2 2014; Anticipated initiation of P1 trial with ACH-3422 outside US in Q2 2014; Anticipated initiation of clinical trial with ACH-3422 in combination with other agents by the end of 2014; Anticipated initiation of P2 trial in Q2 2014 with ACH-3102 and sofosbuvir for durations of 8 weeks and less for the treatment of genotype 1 HCV; Anticipated submission and response from the FDA regarding the clinical hold on sovaprevir in H1 2014. "For the year ended December 31, 2013, the Company reported a net loss of $59.0 million, compared to a net loss of $47.1 million in 2012."

Anticipated FDA event • Anticipated new P1 trial • Anticipated new P2 trial • Anticipated new trial • Anticipated trial completion date • Commercial • Hepatitis C Virus

Achillion granted U.S. patent for ACH-3102 and structurally related NS5A inhibitors (Achillion Press Release) - "Achillion...announced that the U.S. Patent & Trademark Office has granted Achillion U.S. Patent No. 8,809,313, covering composition-of-matter and method of use claims for ACH-3102 and structurally related NS5A inhibitor compounds."

Patent • Hepatitis C Virus

Achillion: Pipeline Update (Achillion) - Anticipated completion of P2 trial for genotypes 2, 3, 4 treatment-naive HCV in Q2 2014; Anticipated initiation of P2 Cirrhotic trial in HCV patients with compensated cirrhosis in Q4 2013; Anticipated completion of P2 Cirrhotic trial in HCV patients compensated cirrhosis in Q4 2013; Anticipated initiation of Apollo-C P2b (sovaprevir + ACH-3102 combo) trial for genotype 1a/b tx-naive HCV patients in Q4 2013; Anticipated completion of Apollo-C P2b (sovaprevir + ACH-3102 combo) trial for genotype 1a/b tx-naive HCV patients in Q2 2014

Anticipated new P2 trial • Anticipated trial completion date • Hepatitis C Virus

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, ACH-3102, and Simeprevir (clinicaltrials.gov) - P2a; N=320; Recruiting; Sponsor: Alios Biopharma Inc.; Phase classification: P2 ➔ P2a; N=140 ➔ 320; Trial primary completion date: Jun 2016 ➔ Jul 2017

Enrollment change • Phase classification • Trial primary completion date • Biosimilar • Fibrosis • Hepatitis C Virus • Immunology

Achillion reports 2014 fourth quarter and year-end financial results (Achillion Press Release) - "Plan to initiate in the first half of 2015 a clinical trial with ACH-3422 in combination with ACH-3102 for patients with treatment-naïve genotype 1 HCV...SVR4 results are expected in the second half of 2015...Plan to initiate during the first quarter a Phase 1 proof-of-concept trial evaluating the anti-viral activity of ACH-3422 for HCV genotypes 2 and 3. Results are anticipated during the second quarter of 2015....Expect to initiate during the first half of 2015 a proxy triplet trial evaluating ACH-3102 and sovaprevir with sofosbuvir...SVR4 results are expected in the second half of 2015; and Expect to initiate by the end of 2015 a pharmacokinetic and viral kinetic study of ACH-3422, ACH-3102 and sovaprevir in patients with treatment-naïve genotype 1 HCV."

Anticipated new P1 trial • Anticipated new P2 trial • Anticipated P1 data • Anticipated P2 data • Hepatitis C Virus

Achillion: ACH-3102 Interim Results (Achillion) - Anticipated initial sustained virological response data from P2 (ACH-3102 + RBV combo) trial for HCV in Q2 2013; Anticipated expansion of enrollment to include non-CC GT 1b treatment-naïve patients in P2 (ACH-3102 + RBV combo) trial in Q1 2013

Anticipated enrollment status • Anticipated P2 data • Hepatitis C Virus

Best Performing 2014 Small Cap Pharmaceutical Stocks: ACHN, PTX & FOLD (SmallCap Network) - "...We expect to report top-line results from our ongoing Phase 1 trial of ACH-3422 later this quarter and look forward to initiating a proprietary combination program evaluating ACH-3422, ACH-3102 and sovaprevir during 2015."

Anticipated P1 data • Hepatitis C Virus

JNJ: Pharmaceutical Business Review (Johnson and Johnson Ltd) - "ACH-3102 + Sofosbuvir (‘Proxy’ Study): 6-week Treatment: Final Efficacy Results"

Clinical data • Hepatitis C Virus

Achillion: Cowen & Company Healthcare Conference (Achillion) - Anticipated initiation of P2 ACH-3422 + ACH-3102 +/- ACH-PI (triple regimen) trial in hep C infection in early 2015

Anticipated new P2 trial • Hepatitis C Virus

Short Duration AL-335, Odalasvir, With/Without Simeprevir, in Patients With HCV GT1 or 3 Infection Without Cirrhosis. (PubMed, Hepatology) - "In treatment-naïve subjects without cirrhosis, AL-335 + odalasvir + simeprevir for 6-8 weeks was generally safe and highly efficacious against HCV GT1. However, inadequate efficacy was observed for the 2-DAA regimen in GT1-infected subjects and the 3-DAA regimen in GT3-infected subjects."

Clinical • Journal • Biosimilar • Fibrosis • Hepatitis C Virus • Immunology • Infectious Disease

Achillion: Corporate Presentation (Achillion) - "ACH‐3102 has been safe and very well tolerated to date; Treatment with ACH‐3102 results in very rapid reduction in HCV RNA"

P2 data • Hepatitis C Virus

Evaluation of safety tolerability and antiviral activity of ACH-0143102 plus RBV treatment naive HCV GT1b subjects (clinicaltrials.gov) - P1, N=16; Sponsor: Achillion; Active, not recruiting -> Completed.

Trial completion • Hepatitis C Virus

A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers (clinicaltrials.gov) - P1; N=32; Completed; Sponsor: Alios Biopharma Inc.; Recruiting ➔ Completed

Trial completion • Biosimilar • Hepatitis C Virus • Immunology • Inflammation

Achillion shoulders its way into the hep C race with strong early data (FierceBiotech) - "The mid-stage results sent Achillion's shares up about 18% in premarket trading on Friday, stoking investors' hopes that the well-traveled biotech might attract a lucrative buyout offer now that hep C has become a cause célèbre among global drugmakers."

P2 data • Stock price • Hepatitis C Virus

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, ACH-3102, and Simeprevir (clinicaltrials.gov) - P2; N=140; Recruiting; Sponsor: Alios Biopharma Inc.; N=60 ➔ 140

Enrollment change • Biosimilar • Hepatitis C Virus • Immunology

Safety, tolerability and efficacy of 12-weeks of sovaprevir, ACH-3102 and ribavirin in treatment-naive GT-1 HCV subjects (clinicaltrials.gov) - P2, N=50; Sponsor: Achillion; Recruiting -> Active, not recruiting.

Enrollment closed • Hepatitis C Virus

Evaluation of the efficacy and tolerability of JNJ-4178 (AL-335, odalasvir, and simeprevir) in hepatitis C virus-infected patients without cirrhosis: The Phase IIb OMEGA-1 study (AASLD 2017) - P2a,P2b; "The OMEGA-1 study will provide further understanding of the efficacy and tolerability of AL-335, ODV, and SMV (as JNJ-4178) in HCV GT1, 2, 4, 5, and 6 infected-pts without cirrhosis. Treatment was well tolerated and not associated with premature discontinuation. SVR12 results will be presented at the meeting."

Clinical • P2 data • Biosimilar • Fibrosis • Hepatitis C Virus • Immunology • Infectious Disease

Achillion: Corporate Presentation (Achillion) - Anticipated presentation of data from P1 proof of concept trial in hepatitis C infection in H1 2015; Anticipated initiation of P2 SPARTA doublet program in combination with ACH-3102 for hepatitis C infection in H1 2015; Anticipated data from P2 SPARTA doublet trial in combination with ACH-3102 for hepatitis C infection in H2 2015; Anticipated initiation of multi-dose pharmacokinetic study in combination with ACH-3102 and sovaprevir for hepatitis C infection in H2 2015

Anticipated new P2 trial • Anticipated new trial • Anticipated P1 data • Anticipated P2 data • Hepatitis C Virus

Achillion: Corporate Presentation (Achillion) - "ACH-3102: Phase 1 Activity Second-generation NS5A Inhibitor"; "Robust activity against genotype 1a and 1b HCV in Phase 1"; "Single dose as low as 25 mg achieved greater than 4.5 log10 reduction in GT 1b HCV"; "Well tolerated with prolonged antiviral activity observed"; "Consistent antiviral effect despite presence of baseline NS5A mutations"

P1 data • Hepatitis C Virus

Achillion: Cowen & Company Healthcare Conference (Achillion) - Anticipated initiation of P2 ACH-3102 + sofosbuvir combo trial in treatment naïve GT1a/1b hep C infected patients in Q2 2014

Anticipated new P2 trial • Anticipated trial initiation date • Hepatitis C Virus

Achillion announces updated phase 2 results including early sustained virologic response on ACH-3102 plus ribavirin in genotype 1b treatment-naive hepatitis C patients (Achillion) - P2, N=8; "In all, 75% of patients (6 of 8) had HCV RNA < 25 IU/ml at the end of treatment and 63% (5 of 8) achieved early sustained virologic response 4 weeks (SVR4) after the completion of therapy ...recently initiated Phase 2 -007 trial ...we look forward to reporting interim results beginning in the third quarter of this year ..."

Anticipated P2 data • P2 data • Hepatitis C Virus

Achillion reports HCV pipeline progress and outlines 2014 HCV milestones (Achillion Press Release) - Anticipated initiation of P1 first-in-human trial ex-US in Q2 2014 and P1 proof-of-concept trial in mid-2014 for ACH-3422 in HCV pts; Anticipated initial results from HCV-infected patients in Q3 2014 for ACH-3422; Anticipated initiation of pilot P2 study early in Q2 2014 for ACH-3102 + sofosbuvir in treatment-naive HCV pts; Anticipated initiation of P2 combination study for ACH-3422 by year-end 2014; Anticipated initiation of P2 trial early 2015 for ACH-3422 + ACH-3102 ± NS3/4A protease inhibitor in treatment-naive HCV pts; Anticipated initiation of P1 drug-drug interaction study in Q1 2014 and anticipated initiation of proof-of-concept study in mid-2014 for ACH-3102 + ACH-2684; Anticipated complete response package on the previously disclosed sovaprevir clinical hold and anticipated response from the FDA by the end of H1 2014.

Anticipated FDA event • Anticipated new P1 trial • Anticipated new P2 trial • Hepatitis C Virus