First Subject Enrolled in OPUS-2, SARcode's Second Pivotal Study of Lifitegrast Ophthalmic Solution
Published: Jan 08, 2013
BRISBANE, Calif., Jan. 8, 2013 /PRNewswire/ -- SARcode Bioscience, Inc., a privately-held biopharmaceutical company, announced today that the initial subject has been enrolled in a second pivotal Phase 3 clinical efficacy study (OPUS-2) of lifitegrast ophthalmic solution 5.0%.
OPUS-2 will assess the efficacy and safety of lifitegrast in the treatment of dry eye disease. Approximately 700 subjects will be randomized to receive lifitegrast or placebo twice daily over 12 weeks. The co-primary endpoints of the study are inferior corneal fluorescein staining score and eye dryness.
"The OPUS-2 study aims to replicate the positive results observed in OPUS-1, the first pivotal Phase 3 efficacy study that was completed last year," said Quinton Oswald, Chief Executive Officer. "Initiating enrollment in our final efficacy study is a significant milestone for SARcode Bioscience as we continue to progress towards our goal of making this therapy commercially available to dry eye sufferers."
"We are very pleased to have enrolled the first patient in the OPUS-2 study. Lifitegrast is a promising treatment for dry eye disease, a common condition for which a new treatment is very much needed. I am encouraged by the positive results observed in OPUS-1, and am hopeful that this new therapy may provide faster and significant relief to the millions of patients living with dry eye," said Dr. Kenneth Sall, an OPUS-2 Principal Investigator from Sall Research Medical Center in Artesia, CA.
Lifitegrast has been studied in over 900 subjects to date and has demonstrated statistical significance in several signs and symptoms of dry eye disease. Dose-dependent improvements were observed in both corneal and conjunctival staining, key indicators of ocular surface health. Lifitegrast also improved eye dryness and ocular discomfort, the two most commonly reported symptoms of dry eye Lifitegrast was well tolerated and there were no unexpected or serious ocular adverse events. The most commonly reported ocular adverse events were irritation and pain upon initial instillation of lifitegrast, and were generally mild and transient in nature.
The results from OPUS-1 and OPUS-2, along with results from an ongoing year-long safety study called SONATA, will support a planned New Drug Application.
Lifitegrast is an investigational novel small-molecule integrin antagonist that was "purpose-built" to meet several specifications that would make it an ideal dry eye therapy candidate. It was chosen from over one thousand synthesized molecules for its ability to specifically and potently block the lymphocyte function-associated antigen-1/intercellular adhesion molecule (LFA-1/ICAM-1) interaction, a validated target in the chronic dry eye inflammatory cycle central to T-cell activation, proliferation, migration, and inflammatory cytokine release at sites of ocular surface stress. Lifitegrast was engineered to provide good penetration into target periocular tissues, but low absorption into the systemic circulation, allowing for local delivery without adverse side effects. The molecule is also highly soluble in water, permitting easy formulation into an ophthalmic solution. Lifitegrast ophthalmic solution is unpreserved and is administered in a single-use unit-dose vial.
About the OPUS-2 Study
OPUS-2 is a prospective, randomized, double-masked, Phase 3 study that will evaluate the efficacy and safety of lifitegrast ophthalmic solution, 5.0%, compared to placebo for the treatment of signs and symptoms of dry eye disease. The study, which includes 21 sites across the US, will enroll approximately 700 subjects with dry eye disease who have used artificial tears in the past 30 days. Subjects will receive lifitegrast or placebo dosed two times a day for 12 weeks. The co-primary endpoints are the mean change from baseline in inferior corneal staining score and the mean eye dryness score, both assessed at 12 weeks. Additional secondary endpoints include total corneal staining, nasal lissamine staining, and ocular/eye discomfort. The safety and tolerability of lifitegrast compared to placebo will also be evaluated.
About Dry Eye Disease
Dry eye disease is a prevalent and often chronic condition estimated to affect approximately 25 million people in the US and 370 million people worldwide. This number is expected to grow substantially in the next decade due to an aging population and increasing incidence of type-2 diabetes, both of which contribute to higher rates of this condition. Dry eye disease is among the most common disorders treated by ophthalmologists throughout the world, and has been shown to have a significant impact upon quality-of-life. Dry eye varies in severity and etiology, and symptoms most commonly manifest as ocular discomfort, eye dryness, and tear film instability due to decreased quality or quantity of tears. A major contributing factor towards the development of dry eye is inflammation caused by T-cell infiltration, proliferation and inflammatory cytokine production that can lead to reduction in tear film quality and ocular surface damage.
About SARcode Bioscience
SARcode Bioscience, Inc., founded in 2006, is a privately held biopharmaceutical company based in Brisbane, CA. SARcode Bioscience's lead development program is a novel class of lymphocyte function-associated antigen-1 (LFA-1) antagonists for the treatment of T-cell mediated inflammatory diseases. Institutional investors include Alta Partners, Clarus Venture Partners, Rho Ventures and Sofinnova Ventures. For more information: www.sarcode.com.
SOURCE SARcode Bioscience, Inc.