Arrowhead Research Corporation ARWR, a biopharmaceutical company
developing targeted RNAi therapeutics, today announced that COO and Head of
R&D, Bruce Given, M.D., presented data on the Phase 1 clinical study of
ARC-520, the company's clinical candidate for the treatment of chronic
hepatitis B infection, at the HepDART 2013 conference being held on The Big
Island, Hawaii. New data including pharmacokinetics (PK) and adverse event
(AE) attribution presented today in a poster and in an oral presentation
tomorrow, support the previous findings that ARC-520 appears to be generally
safe and well-tolerated at all six dose levels studied.
The Phase 1 study was designed to characterize the safety profile of ARC-520
across a range of doses and evaluate pharmacokinetics. It is a single-center,
randomized, double-blind, placebo-controlled, single dose-escalation,
first-in-human study of ARC-520 administered intravenously to healthy adult
volunteers. 36 subjects have been enrolled in 6 groups randomized at a ratio
of 2:1 to receive ARC-520 or placebo: Placebo (n=12), ARC-520 0.01 mg/kg
(n=4), 0.1 mg/kg (n=4), 0.3 mg/kg (n=4), 0.6 mg/kg (n=4), 1.2 mg/kg (n=4), and
2.0 mg/kg (n=4). The placebo group included 7 male and 5 female subjects with
average of 28.1 +/- 9.6 years. The treatment group included 12 male and 12
female subjects with average age of 26.9 +/- 6.7 years. Subjects were admitted
to the unit overnight pre-dose and vital signs, telemetry, ECGs, safety labs,
PK, and adverse events were monitored for 24 hours post-dose. Return visits
occurred for repeat safety evaluations and recording of adverse events at 48
hrs, 72 hours, day 7, day 14 and day 28 post dosing.
Preliminary results from the phase 1 clinical study of ARC-520 indicate that
to date there have been no serious AEs, no dose limiting toxicities, no
discontinuations, and a modest occurrence rate of AEs with no dose related
increase in frequency or severity, with the possible exception of mild
lightheadedness which occurred in two subjects in the 2 mg/kg dose group.
There were no general differences observed or findings rated clinically
significant on vital signs, ECGs, physical examinations, or clinical
laboratories in the ARC-520 groups relative to placebo. Adverse event
frequency and severity did not differ between placebo and ARC-520, with 75% of
both treated and placebo subjects reporting mild or moderate AEs. There was a
low occurrence rate of abnormal laboratory tests, with no observed
relationship to timing or dose. PK results appear to indicate that C[0]
(equivalent to C[Max]) and AUC[0-∞] increase linearly with dose (r^2=0.984).
The Phase 1 study has thus demonstrated that a single intravenous
administration of ARC-520 appears to be safe and well tolerated up to and
including a dose of 2 mg/kg, the highest dose tested. A copy of the poster
presentation is available on the Presentations and Events page of Arrowhead
website at http://www.arrowheadresearch.com/presentations.
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