SARcode Bioscience, Inc., a privately-held biopharmaceutical company, announced today that the initial patient has been enrolled in the company’s pivotal Phase 3 clinical study (OPUS-1) of SAR 1118 ophthalmic solution.
SAR 1118 is a first-in-class molecule that inhibits T-cell inflammation by blocking the binding of two key cellular surface proteins (LFA-1 and ICAM-1) that mediate the chronic inflammatory cascade. SAR 1118 may be able to reduce inflammation associated with dry eye disease.
The OPUS-1 trial will study the safety and efficacy of SAR 1118 in the treatment of dry eye disease. Approximately 588 patients will be randomized to receive SAR 1118 5.0% ophthalmic solution or placebo twice daily over 12 weeks. The co-primary endpoints of the study are corneal fluorescein staining score and visual-related function score (reading, driving at night, computer use, and 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. The safety and tolerability of SAR 1118 compared to placebo at 12 weeks will also be evaluated.
The OPUS-1 study aims to replicate the positive results observed in the Phase 2 dry eye trial, which demonstrated increases in tear production as early as 2 weeks, an improvement in corneal staining, and better visual-functional outcomes in the SAR 1118 treatment groups compared to placebo,said Charles Semba, MD, Chief Medical Officer.Initiating patient enrollment in our Phase 3 trial is a significant milestone for SARcode Bioscience as we continue to progress towards our goal of making this therapy commercially available to millions of dry eye sufferers.
Dry eye is an extremely common and significant problem encountered by eye care professionals,commented Edward Holland, MD, a cornea specialist from the Cincinnati Eye Institute and consultant to SARcode Bioscience.It is exciting to see this new molecular entity, which was specifically designed for ocular use, enter pivotal trials. If the Phase 3 program is successful, this novel therapy will provide a much needed treatment option that not only alleviates the symptoms of dry eye, but also improves visual-related quality-of-life for patients suffering from this disease.
SARcode Bioscience anticipates completion of the OPUS-1 study and topline data in mid-year 2012.
Dry eye disease is a prevalent and often chronic condition estimated to affect approximately 20 million people in the US. This number is expected to grow substantially in the next decade due to an aging population and increased 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.
SAR 1118 is a potent novel small molecule lymphocyte function-associated antigen-1 (LFA-1) antagonist under investigation for a broad range of ocular inflammatory conditions including dry eye and diabetic macular edema. LFA-1 is member of the integrin family of adhesion receptors found on the surface of all leukocytes and represents a therapeutic target central to a number of inflammatory stimuli. SAR 1118 has demonstrated potency in blocking LFA-1 binding to its cognate ligand, intercellular adhesion molecule-1 (ICAM-1), 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, SAR 1118 demonstrated significant improvements in both signs and symptoms of dry eye as early as two weeks. SAR 1118 was well tolerated and ocular adverse events were mostly mild, transient, and related to initial instillation of the drug.
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
Media, Erin Parsons