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Acucela Initiates Phase 2 Clinical Trial Addressing Proliferative Diabetic Retinopathy

2016年05月09日 AM08:36
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Acucela Inc. (Tokyo: 4589) (“Acucela”), a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases, announced today that the company initiated a phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT02753400) with the successful enrollment of the first patient, to assess the benefits of emixustat hydrochloride (emixustat) for the treatment of proliferative diabetic retinopathy (PDR).

Acucela has submitted a clinical study protocol to the US Food and Drug Administration (FDA) and has received Institutional Review Board approval to initiate a randomized, placebo-controlled, phase 2 clinical trial evaluating emixustat in patients with PDR. In this three-month study, 20 patients will be dosed once daily with oral emixustat. Pre-specified study endpoints include changes in cytokine expression levels associated with PDR severity and changes in ocular neovascularization. With the enrollment of the first patient, the phase 2 clinical trial is under way.

Diabetic retinopathy is a progressive condition in which damage to the retinal microvasculature occurs as a result of chronic hyperglycemia. These vascular changes eventually lead to a chronic decrease in oxygen supply (hypoxia) to the retina. PDR occurs when chronic retinal hypoxia causes proliferation of new, fragile vessels that tend to leak fluid and blood. This is the most advanced stage of diabetic eye disease and can result in permanent vision loss. PDR affects over 19 million people worldwide today, and this number is expected to grow to almost 22 million by 2020.1

“I am excited to explore the potential benefit of emixustat in this serious sight threatening retinal disease affecting millions throughout the world,” stated Ryo Kubota, MD, PhD, and Chairman, President and CEO of Acucela.

1 Market Scope, The Global Retinal Pharmaceuticals & Biologic Market, 2015

About Emixustat Hydrochloride

Emixustat hydrochloride (emixustat) is a once-daily, orally administered small molecule that inhibits RPE65, an enzyme crucial to the visual cycle, the chemical pathway in the retina central to the initiation of visual perception. Emixustat has been shown to play a critical role in slowing the progression of multiple retinal degenerative diseases in animal models, including geographic atrophy (GA) secondary to age related macular degeneration (AMD). Emixustat is being developed by Acucela in collaboration with Otsuka Pharmaceutical Co., Ltd. (“Otsuka”). Acucela and Otsuka share commercial rights for emixustat in the USA. Otsuka has exclusive rights in Japan and Asia, while Acucela has exclusive rights in Europe and other countries. Acucela has received fast-track designation for emixustat for the treatment of GA secondary to dry AMD by the U.S. Food and Drug Administration (FDA).

About Acucela Inc.

Acucela Inc. (http://www.acucela.com/ or http://www.acucela.jp) is a clinical-stage ophthalmology company that specializes in identifying and developing novel therapeutics to treat and slow the progression of sight-threatening ophthalmic diseases affecting millions of people worldwide. Acucela’s lead investigational drug candidate, emixustat hydrochloride, is currently in clinical development in collaboration with Otsuka Pharmaceutical Co., Ltd. for geographic atrophy secondary to dry age-related macular degeneration based on Acucela’s proprietary visual cycle modulation technology. Acucela’s pipeline include drug candidates for the treatment of GA, retinitis pigmentosa, proliferative diabetic retinopathy, cataract, and glaucoma.

Cautionary Statements

Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include statements regarding our expectations regarding corporate development activities and the ultimate success of the enterprise; our development plans and ability to successfully commercialize our product candidates; the timing of and results from our and our collaborators’ ongoing clinical trials and pre-clinical development activities; the potential efficacy, future development plans and commercial potential of our and our collaborators’ product candidates and the progress and potential of ongoing development programs. These statements are based on current assumptions that involve risks, uncertainties and other factors that could cause the actual results, events or developments to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: our investigational product candidates may not demonstrate the expected safety and efficacy; our pre-clinical development efforts may not yield additional product candidates; any of our or our collaborators’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; the success of our investigational product candidate, emixustat hydrochloride, depends heavily on the willingness of our collaboration partner to continue to co-develop our investigational product candidate; our clinical trials could be delayed; new developments in the intensely competitive ophthalmic pharmaceutical market may require changes in our clinical trial plans or limit the potential benefits of our investigational product candidates; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. For a detailed discussion of the foregoing risks and other risk factors, please refer to our filings with the Securities and Exchange Commission, which are available on the Company’s investor relations website (http://ir.acucela.com/) and on the SEC’s website (http://www.sec.gov).

“Acucela” and the Acucela logo are registered trademarks or trademarks of Acucela Inc. in various jurisdictions.

View source version on businesswire.com: http://www.businesswire.com/news/home/20160508005034/en/

CONTACT

Acucela Inc.
Corporate Communications
Tomoko Miles
pr@acucela.com

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