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Acucela Announces End of Treatment Period in Phase 2b/3 Clinical Trial of Emixustat Hydrochloride

2016年04月19日 PM03:36
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SEATTLE

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 the completion of the treatment period in the ongoing Phase 2b/3 clinical trial, the S.E.A.T.T.L.E. study, of the investigational visual cycle modulator emixustat hydrochloride (emixustat).

The study enrolled 508 patients with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The last patient has completed the treatment period of 24 months. The primary objective of the study is to detect differences in lesion growth rate between treatment groups. Acucela expects to analyze and report top-line data from this clinical trial by June 2016.

“We are very excited to achieve this critical milestone in the development of emixustat. I would like to thank all patients and physicians participating in the trial. We now look forward to receiving the top-line results from our clinical trial,” stated Dr. Ryo Kubota, MD, PhD, and Chairman, President and CEO of Acucela.

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 GA secondary to 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 The Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride (the S.E.A.T.T.L.E.) Study

The S.E.A.T.T.L.E study compared the efficacy and safety of emixustat to placebo for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). A total of 508 subjects were randomized to receive emixustat 2.5 mg, 5 mg, 10 mg, or placebo, administered orally once daily for up to 24 months. The primary efficacy endpoint was the mean rate of change from baseline in the total area of the GA lesion(s) in the study eye as imaged by fundus autofluorescence. Secondary efficacy endpoints included the mean change from baseline in normal luminance best-corrected visual acuity score and the proportion of subjects who developed choroidal neovascularization in their study eye. Safety and tolerability were assessed on the basis of ocular and non-ocular adverse events, serious adverse events, ophthalmic examination findings, vital signs, physical examination findings, electrocardiogram findings, and laboratory analyses.

About Geographic Atrophy Secondary to Age-related Macular Degeneration

Geographic atrophy (GA) is a severe and advanced form of age-related macular degeneration (AMD), affecting more than 9 million people worldwide (Market Scope, The Global Retinal Pharmaceuticals & Biologic Market, 2015). In GA, the center of the retina (the macula) responsible for high acuity and color vision becomes atrophic; the atrophic lesion grows over time, eventually leading to irreversible blindness. GA is typically present in both eyes and patients frequently report problems with every day activities such as reading and recognizing faces. GA represents a significant unmet medical need as there are currently no approved treatments for this condition.

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, 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/20160418006812/en/

CONTACT

Acucela Inc.
Michael Hasegawa, +81-3-5789-5872
Senior
Director, Corporate Communications
mhasegawa@acucela.com

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