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Ocumension Therapeutics ᆄੰၪൖ͛ي
(Incorporated in the Cayman Islands with limited liability)
(Stock code: 1477)
VOLUNTARY ANNOUNCEMENT
SECOND PHASE III CLINICAL TRIAL OF OT-301 APPROVED IN CHINA
This announcement is made by Ocumension Therapeutics (the "Company", together with its subsidiaries, the "Group") on a voluntary basis to keep the shareholders of the Company and potential investors informed of the latest business updates of the Group.
The board of directors of the Company (the "Board") is pleased to announce that one of the Group's key drug candidates, OT-301(NCX 470), a first-in-class, nitric oxide (NO)-donating prostaglandin analog under joint development by Nicox S.A. ("Nicox") and the Company, has recently obtained an approval from the Center for Drug Evaluation of the National Medical Products Administration of the People's Republic of China for initiating its second phase III clinical trial, namely the Denali trial, in China. The first phase III clinical trial of NCX 470, namely the Mont Blanc trial, has been initiated by Nicox in the United States in June 2020, in which the 0.1% dose was selected over the 0.65% dose through an adaptive design. The 0.065% dose of NCX 470 was the highest dose tested in the phase II clinical trial, namely the Glaucoma Dolomites trial, where demonstrated a superior intraocular pressure ("IOP") lowering treatment effect compared with latanoprost 0.005%, the most widely prescribed first-line therapy for glaucoma and ocular hypertension in China.
The Denali trial is a three-month phase III multi-regional clinical trial evaluating the safety and efficacy of OT-301(NCX 470) ophthalmic solution, 0.1%, versus the current standard of care, latanoprost ophthalmic solution, 0.005%, for the lowering of IOP in patients with open-angle glaucoma or ocular hypertension. The Denali trial, which will also include a long-term safety extension, is expected to randomize approximately 670 patients, at approximately 50 clinical sites in the United States and China. As of the date of this announcement, the Denali trial has been initiated in the United States by Nicox with the first patient enrolled on November 9, 2020.
INFORMATION ON OT-301(NCX 470)
OT-301 (NCX 470) is a new chemical entity invented by Nicox and designed to release both bimatoprost, a United States Food and Drug Administration approved prostaglandin analog, and nitric oxide, for the lowering of intraocular pressure in patients with open-angle glaucoma and ocular hypertension. The Group obtained an exclusive license from Nicox to develop, make, have made, import, export and sell OT-301 (NCX 470) in the Greater China in December 2018, and extended the exclusive right to Korea and 12 countries in Southeast Asia in March 2020.
Cautionary Statement required by Rule 18A.05 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited: The Company cannot guarantee that it will ultimately commercialize OT-301(NCX 470) successfully. Shareholders of the Company and potential investors are advised to exercise caution when dealing in the shares of the Company.
By order of the Board
Ocumension Therapeutics
Dr. Lian Yong CHEN
Chairman and Executive Director
Hong Kong, March 3, 2021
As of the date of this announcement, the Board comprises Dr. Lian Yong CHEN, Mr. Ye LIU, Dr. Zhaopeng HU and Dr. Wei LI as executive directors, Mr. Yanling CAO and Mr. Lefei SUN as non-executive directors, and Mr. Ting Yuk Anthony WU, Mr. Lianming HE, and Mr. Yiran HUANG as independent non-executive directors.