[Asia Economy Reporter Jang Hyowon] GeneOne Life Science announced on the 30th that it has received approval from the U.S. Food and Drug Administration (FDA) for the Phase 2 clinical trial protocol of GLS-1027, an oral therapeutic agent that suppresses severe lung disease following infection with the novel coronavirus disease (COVID-19).
GLS-1027 is an oral low-molecular drug that inhibits cytokines, which are inflammation-inducing substances, and is known to prevent severe lung disease caused by COVID-19 virus infection. The Phase 2 clinical study will evaluate whether administering GLS-1027 preemptively from the time of COVID-19 virus infection can prevent severe pneumonia caused by COVID-19 in 132 confirmed patients.
Dr. Joel Maslow, Chief Medical Officer of GeneOne Life Science, stated, “GLS-1027 has demonstrated excellent efficacy in various inflammatory and autoimmune disease animal model experiments through numerous studies conducted by external research institutions. In particular, GLS-1027 showed efficacy comparable to or better than high doses of dexamethasone, which is currently used as a severe COVID-19 treatment.”
Park Younggeun, CEO of GeneOne Life Science, said, “GLS-1027 is a pill that patients can self-administer at home through a prescription. When taken immediately after COVID-19 infection, it helps prevent severe lung disease and aids patient recovery. In the reality of ongoing pandemics, it can alleviate public anxiety and reduce the burden on the healthcare system, and is expected to replace high-dose steroid COVID-19 treatments that have serious immunosuppressive side effects.”
Meanwhile, GeneOne Life Science is conducting a Phase 2 clinical trial of GLS-1200, a nasal spray treatment to prevent COVID-19 infection, in the United States. With the recent FDA approval for the Phase 2 clinical trial of GLS-1027, a COVID-19 treatment, the company will be conducting two Phase 2 clinical trials in the U.S.
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