Ainos, Inc. (Nasdaq: AIMD, AIMDW), a San Diego-based pioneer in low-dose oral interferon therapeutics, has secured critical regulatory approvals to advance its proprietary VELDONA® platform in two rare disease indications. The Taiwan Food and Drug Administration (TFDA) has approved the company's clinical trial for HIV-related oral warts, while Institutional Review Board (IRB) clearance has been granted for its upcoming Sjögren's Syndrome study.
Both trials will utilize Ainos' next-generation VELDONA® formulation, aiming to confirm or improve upon previous efficacy results while accelerating regulatory approval pathways in both Taiwan and the United States.
Strategic Approach to Rare Disease Market Entry
"The upcoming Taiwan trials using our new formulation aim to confirm efficacy equal to or better than previous results," said Chun-Hsien (Eddy) Tsai, Chairman, President, and CEO of Ainos. "We are also pursuing bridging consultations with both Food and Drug Administration (FDA) and TFDA. If regulators confirm alignment, we could accelerate market entry through a harmonized approval process."
This bridging strategy represents a potentially expedited path to commercialization, leveraging data from Taiwan trials to support U.S. regulatory submissions. The company has also secured a partnership with Taiwan Tanabe Seiyaku for manufacturing and market development of its Sjögren's Syndrome program, further strengthening its commercialization pathway.
Addressing Significant Unmet Needs
Both target indications represent substantial unmet medical needs. HIV-related oral warts, a painful complication affecting many HIV-positive patients, currently lack effective standard treatments. According to UNAIDS data, approximately 39.9 million people globally lived with HIV in 2023, with oral warts representing a poorly addressed therapeutic niche.
Similarly, Sjögren's Syndrome—a chronic autoimmune disease affecting salivary and tear glands—has limited treatment options despite affecting an estimated 400,000 to 3.1 million people in the U.S. alone, primarily women aged 45-55.
"HIV-related oral warts and primary Sjögren's Syndrome both lack effective standard treatments and impose meaningful burdens on quality of life," noted Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos. "As an oral therapy, VELDONA® provides a convenient, non-invasive alternative to injectable interferons—especially important for chronic or immune-compromised patients."
HIV Oral Warts Trial Details
The HIV-related oral warts trial, titled "Evaluation of Human Interferon Alpha Administered Oromucosally in the Treatment of Oral Warts in HIV-Seropositive Subjects Receiving Combination Anti-Retroviral Therapy" (Protocol ID: 03HUHI19), will be conducted at National Taiwan University Hospital (NTUH).
Ainos plans to begin enrollment in June 2025 with targeted completion in the second half of 2026. The study will evaluate the efficacy of VELDONA® plus antiretroviral therapy compared to placebo, with Bestat Pharmaservices Corporation managing the trial under Good Clinical Practice standards.
The market for managing HIV-related HPV manifestations, including oral warts, is estimated at $500-700 million globally, driven by demand for safer and more tolerable long-term treatments.
Sjögren's Syndrome Trial Progress
The Sjögren's Syndrome trial, "An Open-Label Study to Evaluate the Efficacy Of VELDONA® in Patients with Primary Sjögren's Syndrome" (Protocol ID: 24PSS01), received IRB approval from Taipei Medical University - Joint IRB on October 25, 2024. TFDA submission is underway, with clearance expected in August 2025.
This trial will take place at Shuang Ho Hospital and evaluate whether VELDONA® improves salivary flow and alleviates dryness symptoms. Secondary endpoints include ESSPRI/ESSDAI scores, symptom-specific VAS ratings, and salivary gland imaging. Ainos aims to initiate the first patient visit in October 2025 and conclude the trial in the first half of 2027.
The global market for Sjögren's Syndrome therapeutics is projected to reach approximately $3.3 billion by 2030, driven by rising prevalence and increasing demand for effective therapies.
Notably, Ainos has previously completed three U.S. clinical trials evaluating VELDONA® in primary Sjögren's Syndrome. Results showed significant improvement in oral dryness with a favorable safety profile.
VELDONA® Technology Platform
VELDONA® represents Ainos' proprietary low-dose oral interferon-alpha platform, designed to activate immune responses via oromucosal delivery. The technology delivers therapeutic benefit at ultra-low doses, minimizing the systemic side effects often associated with injectable interferons.
With nearly four decades of development behind it, the platform is positioned as a versatile, scalable solution for chronic autoimmune and infectious diseases across global markets. By targeting rare and underserved indications, Ainos aims to establish VELDONA® as a significant player in the immunotherapy landscape.
Broader Corporate Strategy
These clinical advances align with Ainos' broader corporate strategy, which includes three core growth pillars: scent digitization with AI Nose technology, AI-powered point-of-care testing, and VELDONA®.
"We're executing rapidly and building momentum across the VELDONA® platform. Our ability to launch two Taiwan trials in parallel reflects our dedication to capital efficiency, operational strength and delivering innovative, patient-friendly therapies to the market," Mr. Tsai emphasized.
As these trials progress, Ainos will be positioned to potentially address significant unmet needs in two distinct rare disease markets, while advancing its novel approach to oral interferon delivery.
