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Another Evergreen Me-Only Drug Cleared by the FDA for Phase II Clinical Trial
Source:Evergreen Date: Feb,2022 Views: 981

On February 4, 2022, Evergreen Therapeutics Co., Ltd. ("Evergreen Therapeutics" or "Evergreen") announced that the IND for an oral drug for the treatment of dry macular degeneration with independent intellectual property rights, EG-301, was cleared by the US FDA to proceed to its phase II clinical trial.


EG-301, part of Evergreen Therapeutic's ophthalmic pipeline, is an oral medication for the treatment of dry maculopathy in patients over 50 years of age. EG-301 has complete safety data in humans and demonstrated efficacy in animal studies. According to statistics, there were about 100 million people with maculopathy globally in 2020, 90% of which were Dry macular disease (AMD) patients. There are currently no marketed drugs for dry maculopathy, thus EG-301's approval puts Evergreen at the forefront of the global effort to develop drugs for this indication.


Dr. Charles Lee, CMO of Evergreen Therapeutics, said: "We used our own artificial intelligence driven mechanism of drug action assessment platform to explore and predict novel targets, pathogenesis, intraocular effects, lysosomal pharmacokinetics, and development risks of EG-301. EG-301 can enhance the anti-inflammatory and anti-oxidation function of retinal pigment epithelial cells, improve the autophagosome transport function of epithelial cells, inhibit the activation of complement in epithelial cells, and protect the mitochondria. This is the world's first phase II clinical study focusing on this target to confirm the clinical efficacy of EG-301 on dry AMD."


Dr. David Du, CEO of Evergreen Therapeutics, stated: "EG-301 is an important part of Evergreen Therapeutics 's research and development pipeline, and another small molecule product the company is moving to phase II clinical trials. The ability of EG-301 to enter clinical trials demonstrates the company's ability to broaden its product pipeline. Given that there are currently no marketed products to treat this condition, the FDA also has high hopes for EG-301. During our preclinical communication meetings with the FDA, the agency was eager to accelerate the clinical development of this drug candidate and provided many valuable and constructive comments regarding our clinical design. We are committed to ensuring our global leadership position in an indication with great clinical need to lay the foundation for an early launch of EG-301."