Ainos to Launch Taiwan Clinical Study of VELDONA for Sjögren’s Syndrome

Ainos, Inc., a healthcare company specializing in advanced AI-driven point-of-care testing (POCT) and low-dose interferon therapeutics, has announced plans to initiate a clinical study in Taiwan for its very low-dose interferon alpha (VELDONA) in treating Sjögren’s syndrome. This study will be conducted at Taipei Medical University-Shuang Ho Hospital. Ainos has previously conducted eight clinical trials in the U.S. to assess VELDONA®'s efficacy for this condition, with three Phase 3 studies showing positive results in improving unstimulated whole saliva secretion and minimal adverse effects.

Sjögren’s syndrome is an autoimmune disorder where the immune system mistakenly attacks the body’s tissues. This condition can be primary or secondary, the latter associated with other autoimmune diseases like lupus or rheumatoid arthritis. Globally, the prevalence ranges from 1 to 4 per 1,000 people, with about 90,000 patients in Taiwan. It predominantly affects women between 40 and 60 years old, with a female-to-male ratio of 9:1.

A 2022 report from the National Center for Biotechnology Information (NCBI) states that Sjögren’s syndrome affects between 400,000 to 3.1 million adults worldwide, with an average onset age of 45 to 55 years. The global market for Sjögren’s syndrome treatment is expected to grow at a compound annual growth rate of 4.2% from 2023 to 2030.

The upcoming study at Shuang Ho Hospital will be managed by the Allergy, Immunology, and Rheumatology Department and will follow the diagnostic criteria established by the American College of Rheumatology and the European League Against Rheumatism in 2016. The trial aims to recruit 24 patients, each of whom will take three sublingual tablets of VELDONA® daily for 24 to 48 weeks. The main goal is to evaluate the drug’s efficacy in improving saliva secretion and alleviating dryness symptoms in patients with primary Sjögren’s syndrome.

Secondary objectives include measuring changes in the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) for dryness symptoms, evaluating changes in the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI), assessing improvements in oral and ocular symptoms using a visual analog scale (VAS) for eight dryness-related items, and monitoring salivary gland function using a nuclear medicine salivary gland scan.

ComboTrial Consultancy Ltd., a contract research organization certified by the Taiwan Food and Drug Administration (TFDA), will oversee the trial. The Institutional Review Board (IRB) submission has already been completed at Shuang Ho Hospital, and TFDA approval is expected to be submitted in October 2024. Regulatory approvals are anticipated to be completed by November 2024, with the first patient visit projected for December 2024.

Patient enrollment will take approximately six months, with the last patient's first visit expected by May 2025 and the final patient visit by November 2025. The study is expected to conclude in January 2026.

Ainos has previously conducted eight clinical trials in the U.S. to evaluate VELDONA® for treating Sjögren’s syndrome, including three Phase 3 trials. The first Phase 3 study involved 241 patients in a 24-week double-blind, placebo-controlled trial. The treatment group showed a significant increase in unstimulated whole saliva compared to the placebo group, with no serious adverse events. The second study, also 24 weeks long and double-blind, included 256 patients and showed a trend toward increased saliva secretion, though it did not reach statistical significance. The third study was a 48-week open-label safety study with 288 patients, showing significant improvements in oral dryness and comfort, along with all eight dryness symptoms assessed, without serious adverse events.

Chun-Hsien (Eddy) Tsai, Chairman, President, and CEO of Ainos, expressed optimism about VELDONA®'s potential to improve the quality of life for Sjögren’s syndrome patients, believing it could become a valuable treatment option for the condition.