Sunday, November 13, 2016 11:39:14 PM
http://www.aasld.org/sites/default/files/2016-AbstractSupplement-TheLiverMeeting.pdf
1453
Safety, Tolerability, Pharmacokinetics (PK) and Antiviral
Activity of EDP-494 a Potent Pan-Genotypic Cyclophilin (Cyp) Inhibitor for Chronic Hepatitis C Infection (CHC), in Healthy Subjects (HS) and in CHC Genotype 1 and 3
Patients: Preliminary Result
Background:
Current HCV Direct Acting Antiviral therapies
(DAAs) are not pangenotypic and can select for resistant
variants, thereby limiting retreatment options. Host Targeting Agents (HTA), like EDP-494, an oral Cyp inhibitor are being developed in response to this unmet medical need
The key objectives of this randomized, double-blind, placebo (P)-controlled single ascending dose (SAD) and food effect (FE) in HS and multiple ascending doses (MAD) in HS and in patients with CHC (POC) were to identify a safe and pharmacodynamically-active dose to be used in subsequent clinical studies.
[NCT0265237]
Methods:
Healthy and CHC men and women
(non-childbearing potential) aged 18-55/70 years were ran-
domized to receive a single (SAD) or multiple (MAD, POC) oral doses of EDP-494 or P.
In the SAD, 6 cohorts were evaluated, each containing 8 subjects (6 EDP-494, 2 P), starting with 50 mg followed by 100, 200 (fasted & fed), 400, 800 and 1200 mg.
In the ongoing MAD, 3 cohorts (200, 400 and
800 mg QD) of 8 subjects each have completed 14 days of
dosing and 1 week of follow-up. Safety assessments included
adverse events (AEs), vital signs, ECG and clinical laboratory
parameters. Serial blood samples were drawn for PK evalua-
tion.
Final SAD/ FE, and preliminary MAD results are reported
here; final MAD and preliminary POC results will be available at the time of presentation
.
Results:
All enrolled subjects but 2 who withdrew consent (72/74) completed the study (all males; mean age 28 years).
28/60 (47% SAD subjects) and 13/24 (54% MAD subjects) reported at least 1 AE. All AEs but one were mild and the most frequent were GI symptoms, headache and venipuncture bruises. There were no Grade 3 or 4 AEs, SAEs, discontinuations due to AEs, or dose-limiting toxicities.
Maximum tolerated dose was not reached in
the SAD and dose escalation continues in the MAD.
In SAD cohorts, exposure to single doses of EDP-494 increased in a dose-proportional manner (mean plasma Cmax, AUC0-24hr and AUC0-168hr).
Absorption was rapid with a median Tmax of 3-5 h.
As expected, higher concentrations of EDP-494 in blood compared to plasma were observed
.
Conclusions:
EDP-494 had a favorable safety profile and was well tolerated in
healthy subjects based on final and preliminary analysis of
subjects receiving a single dose up to 1200 mg or multiple QD
doses up to 800 mg for 14 days
.
EDP-494 also demonstrated a desirable PK profile, with rapid absorption, low PK variability, long half-life and dose-proportional exposure .
Preliminary viral kinetic data in the POC patients will be presented
Phase II studies are planned to explore combinations of this new HTA with DAAs in different patient populations.
===========================
(not much to comment on); it appears to be safe.
I haven't heard about the viral kinetics.
Since it is host based and not subject (or less so) resistance it had a longer monotherapy period. In this I would/could expect a large viral decline. Luly barely spoke about it as the last stock pitch.... I'm very interested in seeing how it did; heard nothing on twitter.
Most of the ENTA AASLD talk on twitter was NASH
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