BUSINESS WIRE
Phase 1 Findings for ACU-4429, a Novel Oral Treatment to be Presented
BOTHELL, Wash.--(BUSINESS WIRE)--Acucela, a clinical-stage biotechnology company focused on developing
new treatments for blinding eye diseases, announced today that data for
the company’s novel visual cycle modulator, ACU-4429, a potential oral
treatment for dry age-related macular degeneration (dry AMD), will be
featured at the 8th International Symposium on Ocular Pharmacology and
Therapeutics (ISOPT) being held in Rome, Italy from December 3 to
6, 2009. The data will be presented during the Retina: Dry AMD portion
of the ISOPT program on Saturday, December 5, 2009 at 10:20 a.m. CET in
Hall A of the Rome Cavalieri Hilton.
Nancy Boman, M.D., Ph.D., Acucela’s vice president, clinical development
and regulatory affairs, will present data from a recently completed
Phase 1 study assessing the safety, tolerability, pharmacokinetics and
pharmacodynamics of ACU-4429 administration in healthy volunteers aged
55-80. This Phase 1 trial was a single-center, randomized,
double-masked, placebo-controlled, dose-escalation study. Data from the
trial demonstrated a well-tolerated, dose-dependent modulation of the
visual cycle using electroretinography (ERG), an established eye test in
the evaluation of response and recovery of the retina that is used to
help diagnose disease. Importantly, these data also marked the first
time that a non-retinoid therapeutic in a convenient, oral pill form has
effectively targeted the visual cycle in a dose-dependent manner.
“Dry AMD is a leading cause of vision loss in people over the age of 50
and there are no therapies currently approved to treat this condition,”
stated Dr. Boman. “These data suggest that ACU-4429 may effectively slow
the eye’s visual cycle and have broad potential for treating a range of
degenerative eye conditions. As we further advance our clinical
development program, it is exciting that ACU-4429 clinical data continue
to reinforce our preclinical findings and we look forward to discussing
these data in greater detail at ISOPT 2009.”
Initial data from this Phase 1 clinical trial have been presented at key
scientific meetings earlier this year and, along with these full
findings, provide support and clinical rationale for Acucela’s ACU-4429
clinical development program in patients with dry AMD. The company
expects to launch an ACU-4429 Phase 2 clinical trial shortly.
About ACU-4429
ACU-4429 utilizes Acucela’s proprietary visual cycle modulation (VCM)
technology, and is designed to prevent or inhibit the generation of
toxic by-products of the visual cycle that can lead to degenerative eye
conditions like dry AMD. Data indicate that ACU-4429 slows the rod
visual cycle, resulting in decreased accumulation of a toxic by-product
that is the precursor of lipofuscin, which are deposits of toxic
substances. The chronic accumulation of lipofuscin has been implicated
in degenerative retinal diseases. ACU-4429 is administered to patients
as an oral, daily pill rather than by injection into the eye, which is
typical of many current eye therapeutics. Acucela has forged a strategic
partnership with Otsuka Pharmaceutical, Co. Ltd. to co-develop ACU-4429
in dry AMD as well as other potential indications in North America.
About Acucela Inc.
Acucela Inc. is a clinical-stage biotechnology company focused on
leveraging promising science in visual cycle modulation (VCM) to develop
new methods for treating blinding eye diseases that affect tens of
millions of people worldwide. The company’s orally-delivered VCM
therapies, which selectively target cells within the retina to protect
visual acuity, have the potential to be used to treat several
devastating eye diseases, including dry age-related macular degeneration
(AMD), retinopathy of prematurity, Stargardt disease and diabetic
retinopathy. Acucela is also developing, with Otsuka Pharmaceutical,
Rebamipide ophthalmic suspension, a product candidate for dry eye. For
more information, please visit www.Acucela.com.