Ainos, Inc. announced significant progress in advancing its VELDONA oral interferon drug platform for rare diseases. The Taiwan Food and Drug Administration (TFDA) has approved the company's clinical trial for human immunodeficiency virus (HIV)-related oral warts. Concurrently, Institutional Review Board (IRB) clearance has been granted for its upcoming Sjögren's Syndrome (pSS) study.
These dual regulatory advancements accelerate VELDONA's path toward market entry in the rare disease space. The company is employing a bridging strategy aimed at fast-tracking U.S. regulatory approvals. This progress underscores Ainos' commitment to developing novel therapeutic candidates for underserved medical conditions.
The TFDA approval for HIV-related oral warts follows previous IRB approval, allowing the trial to commence. The IRB clearance for Sjögren's Syndrome also moves that study closer to initiation. These milestones are critical for validating VELDONA's potential and expanding its clinical development.
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