Ainos aims to complete all regulatory approvals for the study in Q4 2024
SAN DIEGO, CA / ACCESSWIRE / September 23, 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, is pleased to announce that it plans to conduct a Taiwan clinical study for very low-dose interferon alpha (VELDONA) on treating Sjögren's syndrome at Taipei Medical University-Shuang Ho Hospital. A total of eight clinical trials have been conducted in the U.S. by the Company to evaluate the use of VELDONA® for treating Sjögren's syndrome. Three Prior Phase 3 studies show positive benefits in increasing unstimulated whole saliva secretion without significant adverse effects.
Disease overview Sjögren's syndrome is an autoimmune disease in which the body's immune system mistakenly attacks its own tissues. The disease can be classified as primary (without associated autoimmune diseases) or secondary (associated with conditions such as lupus, rheumatoid arthritis, and systemic sclerosis). The global prevalence of Sjögren's syndrome is estimated to be 1 to 4 per 1,000 people, with approximately 90,000 patients in Taiwan. The disease primarily affects middle-aged women between 40 and 60 years old, with a female-to-male ratio of 9:1.
According to a 2022 report from the National Center for Biotechnology Information (NCBI), Sjögren's syndrome affects between 400,000 to 3.1 million adults globally, with an average onset age of 45 to 55 years.
The global market for Sjögren's syndrome treatment is projected to grow at a compound annual growth rate of 4.2% from 2023 to 2030.
Clinical Study Design and Objectives The upcoming study will be conducted by the Allergy, Immunology, and Rheumatology Department at Shuang Ho Hospital. The trial will follow the diagnostic criteria established by the American College of Rheumatology and the European League Against Rheumatism in 2016, aiming to recruit 24 patients. Each participant will take three sublingual tablets of VELDONA® daily for 24 to 48 weeks.
The primary objective is to evaluate the efficacy of VELDONA® in improving saliva secretion and dryness symptoms in patients with primary Sjögren's syndrome.
Secondary objectives include: 1. Measuring the change in the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) for dryness symptoms on a scale from 0 to 10 (0 = no symptoms, 10 = worst imaginable symptoms); 2. Evaluating changes in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI); 3. Assessing improvements in oral and ocular symptoms using a visual analog scale (VAS) for eight dryness-related items; 4. Monitoring salivary gland function using a nuclear medicine salivary gland scan.
Study Timeline and Progress ComboTrial Consultancy Ltd., a contract research organization certified by the Taiwan Food and Drug Administration (TFDA), will manage the clinical trial.
Institutional Review Board (IRB) submission has been completed at Shuang Ho Hospital. TFDA approval is expected to be submitted in October, 2024. The trial is anticipated to complete all regulatory approvals by November 2024, with a site initiation meeting (SIV) and first patient visit (FPFV) projected for December 2024.
The patient enrollment will last approximately six months, with the last patient's first visit (LPFV) expected by May 2025, and the last patient's last visit (LPLV) by November 2025. The study is expected to conclude in January 2026.
Prior VELDONA® Studies: A total of eight clinical trials have been conducted by the Company for evaluating VELDONA® for treating Sjögren's syndrome in the U.S., including three Phase 3 trials. Three prior Phase 3 clinical trials demonstrated promising results in improving oral dryness symptoms without significant adverse effects.
1. First Study: A total of 241 patients were randomized in a 24-week double-blind, placebo-controlled study. Patients were given either placebo or 150 IU HBL IFNα three times daily. Results showed a significant increase in unstimulated whole saliva (p<0.05) in the treatment group compared to the placebo group. No other significant treatment effects were observed. There were no serious adverse events or deaths, and no significant differences in adverse event rates or severity between the groups.
2. Second Study: This 24-week double-blind, placebo-controlled trial included 256 patients. The treatment group showed a trend toward increased unstimulated whole saliva (p<0.10), but it did not reach statistical significance. No serious adverse events were reported, and safety profiles between the treatment and placebo groups were similar.
3. Third Study: A total of 288 patients participated in a 48-week open-label safety study. All patients received 150 IU HBL IFNα three times daily. By the end of the treatment, patients experienced significant improvements in oral dryness and comfort (p<0.0001), along with significant improvements in all eight dryness symptoms assessed (p<0.05). No serious adverse events were observed, and no clinically significant changes in safety parameters were detected.
"Based on these findings, Ainos is optimistic about VELDONA®'s potential to improve the quality of life for people living with primary Sjögren's syndrome and believes it may become a valuable treatment option for the condition," Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented.
About Ainos, Inc. Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and low-dose interferon therapeutics (VELDONA). The Company's clinical-stage product pipeline includes VELDONA human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform.
The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. To learn more, visit https://www.ainos.com.
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The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Any forward-looking statements contained in this press release represent Ainos' views only as of today and should not be relied upon as representing its views as of any subsequent date. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.
