On April 26, 2022 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported the positive results from the GLP toxicology study of PMC-403, the Company’s novel TIE2-activating antibody (Press release, PharmAbcine, APR 26, 2022, View Source;bmode=view&idx=11279911&t=board [SID1234649181]).
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PMC-403 can stabilize and repair damaged and pathologically leaky blood vessels, and it is being developed to treat AMD (Age-related Macular Degeneration), one of the most prevalent neovascular ophthalmology diseases.
With the goal of establishing safety profile in animal models before entering the human trial, the study was conducted to evaluate the toxicokinetics and toxicity of PMC-403. The drug was administered via monthly intravitreal injection to monkeys in different dosing groups.
The result of the study showed that there were no serious safety issues in the test subjects (n=32). There were no unscheduled deaths and no organ weight changes even when PMC-403 was administered with twice the dosage of that of the existing drugs.
"We concluded that PMC-403 is safe enough to be administered in human trials," said Dr. Jin-San Yoo, CEO of PharmAbcine. "The vessel-normalizing mechanism makes PMC-403 a potent drug that can offer longer dosing interval and also be utilized in many other vessel-related diseases, such as chronic kidney diseases, ARDS (Acute Respiratory Distress Syndrome), and sepsis."
Dr. Yoo added, "In addition to the study result, Dr. Quan Dong Nguyen, our newly appointed Scientific Advisory Board member and a world-renowned expert in ophthalmology from Stanford University, will provide tremendous insight to our development efforts. Both of these events are critical milestones in the preparation of PMC-403 for the Phase I clinical trial in ophthalmology. The Company will submit the IND package in 3Q22."