Last Patient Enrolled in Pivotal Phase 3 Dry Eye Study (OPUS-1) of SAR 1118 Ophthalmic Solution Lifitegrast Adopted as Generic Name for SAR 1118
BRISBANE, Calif., March 5, 2012 /PRNewswire/ -- SARcode Bioscience, Inc., a privately held biopharmaceutical company, announced today that it has completed patient enrollment in their first pivotal Phase 3 clinical study (OPUS-1) of SAR 1118 ophthalmic solution. SAR 1118 is a first-in-class small-molecule integrin antagonist that inhibits T-cell inflammation by blocking the binding of two key surface proteins (LFA-1 and ICAM-1) that mediate the chronic inflammatory cascade associated with dry eye disease.
OPUS-1 is a randomized, double-masked study evaluating the safety and efficacy of SAR 1118 5.0% ophthalmic solution compared to placebo over a 12 week period. A total of 588 patients with dry eye disease have been enrolled at 13 clinical sites across the US. The primary endpoints in this study will assess both a sign and a symptom of dry eye disease, and include corneal fluorescein staining score and vision-related function score (reading, driving at night, computer use, watching television) as measured by the Ocular Surface Disease Index (OSDI; a validated instrument designed to assess the impact of dry eye upon vision-related activities).
"We are pleased to have reached this significant milestone in our clinical development of SAR 1118 and appreciate the dedication of our investigators, the clinical trial team, and patients who have volunteered for this important study," said Charles Semba, MD, Chief Medical Officer. "We look forward to the eventual analysis of the top-line data once OPUS-1 is completed and expect to announce these results mid-year."
Additionally, SARcode Bioscience announced that the United States Adopted Name (USAN) Council and the World Health Organization's International Nonproprietary Names (INN) program have adopted "lifitegrast" as the nonproprietary name for SAR 1118. Lifitegrast is an integrin antagonist specifically developed for topical ophthalmic use and targets a key cellular step that initiates a perpetual cycle of inflammation recognized to be central to the most common forms of dry eye disease.
"We believe that lifitegrast will represent a significant advance in dry eye treatment, since it may address not only a clinical sign but also improve a patient's ability to function in the face of this often debilitating condition," commented Quinton Oswald, Chief Executive Officer. "Completion of recruitment for this trial and the adoption of a generic name for this new molecular entity are both important achievements as we continue the development of this much-needed therapeutic for dry eye patients."
About Dry Eye Disease
Dry eye disease is a prevalent and often chronic condition estimated to affect approximately 25 million people in the US. 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 discomfort, visual disturbances, 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 Lifitegrast (SAR 1118)
Lifitegrast is a potent novel small molecule lymphocyte function-associated antigen-1 (LFA-1; CD11a/CD18) antagonist under investigation for a broad range of ocular inflammatory conditions including dry eye. LFA-1 is member of the integrin family of adhesion receptors found on the surface of CD4+ lymphocytes (T-cells) and represents a therapeutic target central to a number of inflammatory stimuli. Lifitegrast has demonstrated potency in blocking LFA-1 binding to its cognate ligand, intercellular adhesion molecule-1 (ICAM-1; CD54), thereby inhibiting cell adhesion, cytokine production, and cellular proliferation in in vitro models. In a Phase 2 trial randomized, placebo-controlled trial of 230 subjects with dry eye disease, lifitegrast demonstrated significant improvements in both signs and symptoms of dry eye as early as two weeks. Lifitegrast was well tolerated and ocular adverse events were mostly mild, transient, and related to initial instillation of the drug.
About SARcode Bioscience
SARcode Bioscience, Inc., founded in 2006, is a venture-backed ophthalmic 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 T-cell mediated inflammatory diseases. Institutional investors include Alta Partners, Clarus Venture Partners, Rho Ventures and Sofinnova Ventures. www.sarcode.com.
SOURCE SARcode Bioscience, Inc.