RegeneRx Biopharmaceuticals Inc (RGRX)

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GTRIBNT completes phase 3 clinical trial for dry eye syndrome (ARISE-3) data lock-up

By GtreeBNT 2021 years 2 24-days Mon. - , Press Releases

GTRIBNT (115450) is a data lock-up that prevents modification of all numbers and information of clinical data conducted at 20 hospitals across the United States for ARISE-3, phase 3 clinical trial of dry eye treatment (RNG-259). It was announced on the 24th that it was completed.

A GTRIBNT official said, "We have completed data cleaning, which is the current ARISE-3 clinical data cleanup task, and have completed Data Lock-Up to confirm and collect clinical data in 20 US hospitals." As soon as the statistical analysis of variables as well as all endpoints in the protocol is completed, the results will be disclosed in Korea and the United States, especially as some multinational companies are already waiting for the results of ARISE-3 I will derive data.”

GTRIBNT has already secured major intellectual property rights such as patents for compositions and pharmaceutical formulations, and patents for manufacturing method of eye drops for future market monopoly along with the progress of phase 3 clinical trials related to the development of new dry eye drugs, as well as the US FDA. As the product approval process is divided into a biologics license application (BLA), a 12-year monopoly on the new drug market can be granted upon approval.

Meanwhile, in a report published in June 2020 regarding the dry eye treatment market,'Global Data', an overseas analysis agency, predicts the dry eye treatment market in 9 countries, including the United States, at 13 trillion won. Compared to Zydra, Gtree B&T's RGN-259 is predicted to have the largest cumulative sales from 2022 to 2028, as it has a competitive edge in that it has no discomfort such as a burning sensation and rapid drug expression.

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