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Sjogren's Syndrome is a rare autoimmune disease with limited treatment options
Prior U.S. Phase 3 data demonstrated benefits
SAN DIEGO, CA / ACCESSWIRE / September 24, 2024 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), an innovative healthcare company focused on advanced AI-driven point-of-care testing ("POCT") and low-dose interferon therapeutics, today announced that Water Tower Research ("WTR") has published a report highlighting the Company's upcoming clinical study for VELDONA® in treating primary Sjogren's syndrome, targeted to begin in December 2024 in Taiwan.
The report emphasizes Ainos' capital-efficient strategy in conducting clinical trials within Taiwan. Following a planned November 2024 VELDONA study for oral warts in HIV+ patients, next will be a single-site clinical trial for Sjogren's syndrome. 24 patients will be enrolled to assess VELDONA®'s effectiveness in reducing dryness symptoms over a 24 to 48-week period. Approval from Taiwan's Food and Drug Administration (TFDA) for the study is expected by November 2024, with the trial projected to complete by January 2026.
Key Highlights from the Report:
Sjogren's Syndrome Study: The primary endpoint is to evaluate VELDONA® in the improvement of saliva secretion and dryness symptoms, with secondary endpoints of EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI), EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), a visual analog scale (VAS) and salivary gland function.
No Approved Therapies: Sjogren's syndrome, a systemic autoimmune disease, affects up to 1% of the global population, predominantly middle-aged women, and lacks approved curative therapies.
Previous U.S. Phase 3 Data: VELDONA® demonstrated significant improvements for unstimulated whole saliva flow and oral dryness in previous U.S. clinical trials.
