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Clinical Trials

Date: 2015-12-21

Type of information: Halting of the trial

phase: 1

Announcement: halting of the development

Company: Alios Biopharma, a J&J company (USA - NJ) Janssen Pharmaceutica, a J&J company (USA - NJ)

Product: JNJ-54257099/AL-704

Action mechanism:

  • NS5B polymerase inhibitor/enzyme inhibitor/nucleotide. AL-704 is a nucleotide based NS5B polymerase inhibitor intended for the treatment of chronic hepatitis C virus (HCV) infection in combination with other direct acting antiviral agents.
  • Medivir entered a R&D agreement in the field of HCV polymerase with Janssen Products in May 2008.

Disease: chronic hepatitits C

Therapeutic area: Infectious diseases

Country: France, Georgia, Republic of Moldova

Trial details: This  Phase 1, randomized, double-blind, placebo-controlled, first-in-human, 3-part study evaluated the safety, tolerability, and pharmacokinetics of orally administered AL-704  in healthy adult subjects and in adult subjects with CHC infection. Part 1: Healthy adult subjects will receive one of 5 single ascending oral doses (SAD) of AL-704 ranging from 100 mg to 1,500 mg (Cohorts 1 to 5). Within each cohort subjects will be randomized to receive either AL-704 or placebo (n=8 per cohort; 6 assigned to AL-704 and 2 assigned to placebo), in a fasted state. The planned dose-escalation scheme may be changed based on the emerging PK and safety data. Two additional cohorts (Cohorts 6 and 7) may be enrolled for evaluation of additional doses at the discretion of the Sponsor and Investigator, based on the emerging pharmacokinetic (PK) profile, and the presence of an acceptable safety profile. Part 2: To assess the food effect on pharmacokinetics, 8 healthy subjects from one full Part 1 cohort who received a single dose of AL-704 or placebo in a fasted state, will receive the same single dose of AL-704 or placebo in a fed state in Part 2 after a washout period of 7-14 days (depending on PK results). It is expected that Cohort 3 of Part 1 (600 mg dose) will be selected, however this depends on the evaluation of available PK and safety data from Part 1 of the study. Part 3: The following cohorts of 10 adult subjects each, with CHC infection, will be evaluated. Subjects with CHC genotype 1 infection (Cohorts 8 to 10) and subjects with CHC genotype 3 infection (Cohort 11) will be randomized to receive AL-704 or placebo for 7 consecutive days (n=10 per cohort, 8 assigned to AL-704 and 2 assigned to placebo) in a fed state. The treatment is anticipated to be administered in a once daily dose regimen or a twice daily dose regimen. The dose and dose regimen to be administered will be determined by the Sponsor depending on the PK and safety outcomes of previous cohorts.

Latest news:

  • • On December 21, 2015, Medivir announced that the development of AL-704 (also known as JNJ-54257099) has been terminated following completion of phase I clinical studies conducted by Alios Biopharma, one of the Janssen Pharmaceutical Companies. These studies demonstrated that AL-704 was safe, well tolerated and had acceptable pharmacokinetic properties. However its clinical antiviral activity in persons infected with HCV genotype 1 was insufficient to justify further clinical studies. No further compounds arising from Medivir’s license agreement with Janssen on HCV NS5B polymerase inhibitors are expected to be progressed into clinical studies, and therefore no further revenues from this agreement will be received.
  • • On July 29, 2015, Medivir announced the start of a phase I clinical trial with AL-704, also known as JNJ-54257099, by Alios Biopharma, part of the Janssen Pharmaceutical Companies.

Is general: Yes