Ainos Inc. (NASDAQ:AIMD) is planning to launch a Phase 3 clinical trial in Taiwan to evaluate Veldona, its investigational low-dose formulation of interferon-alpha, for treating primary Sjögren's disease. The trial, expected to begin in December 2024, will assess Veldona's effectiveness in improving saliva secretion and reducing dryness symptoms, addressing a significant unmet need in this patient population.
The study, to be conducted at Taipei Medical University-Shuang Ho Hospital, anticipates regulatory approvals by November 2024 and aims for completion by January 2026. It will enroll 24 patients with primary Sjögren’s syndrome, each receiving three sublingual tablets of low-dose interferon-alpha daily for 24 to 48 weeks.
Prior Clinical Evidence
Ainos reports that previous Phase 3 trials in the U.S. have demonstrated that Veldona improved saliva production and eased dryness symptoms in Sjögren’s patients, without causing significant side effects. According to Chun-Hsien (Eddy) Tsai, chairman, president, and CEO of Ainos, the company is optimistic about Veldona’s potential to improve the quality of life for individuals with primary Sjögren’s, potentially offering a valuable treatment option.
Two earlier Phase 3 trials involved a total of 497 patients with primary Sjögren’s disease across 51 U.S. sites. Patients were treated with 150 international units (IU) of human interferon-alpha or a placebo, administered as sublingual tablets three times daily for 24 weeks. Results indicated a significant increase in unstimulated whole saliva flow rate in the interferon-alpha group compared to placebo, which correlated with reduced mouth and eye dryness. No significant differences in adverse event frequency or severity were observed between the groups.
Another open-label Phase 3 trial, involving 288 patients, showed that low-dose interferon-alpha significantly eased oral dryness and related symptoms after approximately one year of treatment, using the same dosage and administration route.
Trial Design and Endpoints
The upcoming trial's primary goal is to evaluate the efficacy of low-dose interferon-alpha in increasing saliva production and alleviating dryness symptoms. Secondary objectives include assessing changes in the EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) and the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI).
Sjögren's Syndrome: Disease Context
Sjögren’s disease is an autoimmune condition where the immune system mistakenly attacks moisture-producing glands, leading to hallmark symptoms of dry eyes and mouth. It can manifest as a primary condition or secondary to other autoimmune diseases like lupus or systemic sclerosis. Affecting up to 1% of the global population, Sjögren's syndrome lacks approved curative therapies, highlighting the need for effective treatments.
Interferon-alpha Mechanism
Interferon-alpha is a key signaling molecule in the body’s immune response to viral infections. It can halt viral infections by destroying infected cells, activating immune cells, and preventing viral replication. Prior research suggests that low doses of oral interferon-alpha can enhance saliva production in Sjögren’s disease patients.
Ainos' Strategy and Market Opportunity
Ainos is employing a capital-efficient strategy by conducting clinical trials in Taiwan. The company is also planning a VELDONA study for oral warts in HIV+ patients. The Sjogren's syndrome market, while niche, represents a potentially lucrative opportunity, as rare disease treatments often command premium pricing.
