PRG S&Tech Launches Phase 2 Trial of Anti-Aging Drug in Adult Progeria Patients
PRG S&Tech is launching a Phase 2 clinical trial of progerinin, an anti-aging drug, in patients with adult progeria.
According to PRG S&Tech on October 8, the company completed the Site Initiation Visit (SIV) for the Phase 2 trial of progerinin in patients with adult progeria at the University of Michigan in the United States last month and began enrolling patients.
An SIV is a procedure conducted before a clinical trial begins to share the trial plan and key procedures with the research team and make final checks on matters necessary to carry out the trial, including patient enrollment and drug administration.
In this Phase 2 trial, progerinin will initially be administered to five patients with adult progeria to evaluate its efficacy and safety. The patient group is expected to expand to up to 20 as the trial progresses.
Progerinin has previously undergone three Phase 1 clinical trials in healthy adults to evaluate its safety and tolerability, and the trials were completed without serious adverse events. The drug was also made available to patients with adult progeria through an Expanded Access Program (EAP) at Cincinnati Children's Hospital Medical Center in the United States for about two years. No serious adverse events were identified during treatment under the program, and meaningful results were observed in some measures.
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"With the SIV completed and patient enrollment underway, we have officially launched the Phase 2 trial of progerinin in patients with adult progeria in the United States," said Park Beomjun, CEO of PRG S&Tech. "We will work closely with the research team at the University of Michigan on patient enrollment and treatment, and systematically assess progerinin's efficacy and safety through the Phase 2 trial."
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