Ainos, Taiwan Tanabe to manufacture low-dose interferon alpha for Sjögren’s
Treatment improved saliva production, eased dryness in clinical trials
Ainos is partnering with Taiwan Tanabe Seiyaku, a subsidiary of Mitsubishi Tanabe Pharma, to advance the manufacturing and promotion of its investigational low-dose formulation of interferon alpha for Sjögren’s disease in Taiwan.
Both parties will clarify the details of the partnership in a formal agreement. According to Ainos, the collaboration is expected to accelerate the therapy’s introduction into the global market, a key step toward ensuring that patients have a timely and efficient access to treatment.
“This partnership with Taiwan Tanabe Seiyaku marks an important milestone in our global strategy and we will continue to focus on developing breakthrough therapies that improve the quality of life for patients worldwide,” the company said in a press release.
A systemic disease, Sjögren’s occurs when the immune system mistakenly launches an inflammatory attack against the glands that produce tears and saliva, which leads to eye and mouth dryness, the disease’s hallmark symptoms. Sjögren’s is classified as primary if it appears isolated and secondary when it’s associated with other autoimmune conditions, such as lupus or systemic sclerosis.
Clinical trial results of interferon-alpha
Interferon alpha is a signaling molecule involved in the immune response to viral infections. It triggers several effects to stop a viral infection, including destroying infected cells, activating immune cells to participate in the fight against the infection, and preventing viral replication.
The efficacy of a low-dose formulation of interferon alpha, known as Veldona, was evaluated in three Phase 3 clinical trials that showed the treatment significantly improved the production of saliva and eased dryness symptoms in people with primary Sjögren’s disease.
Ainos announced plans this year to launch a new clinical trial in Taiwan to evaluate the efficacy of Veldona in primary Sjögren’s disease. The company recently announced it received Institutional Review Board (IRB) approval from Shuang Ho Hospital, which is affiliated with Taipei Medical University and where the study will take place. This is a key step in initiating a clinical trial to ensure it’s scientifically valid and carried out ethically.
The new open-label trial will assess the therapy’s effectiveness at improving salivary flow and easing dryness symptoms in 24 people with primary Sjögren’s. The participants will receive three sublingual tablets of low-dose interferon alpha daily for 24 to 48 weeks, that is, six months to about a year.
Secondary goals include assessing changes in dryness symptoms using the European League Against Rheumatism Sjögren’s Syndrome Patient Reported Index (ESSPRI), as well as changes in disease activity. The effects of treatment on specific dryness symptoms, including mouth and eye dryness, and salivary gland function based on imaging tests will also be assessed.
Ainos plans to submit the trial design to Taiwan’s Food and Drug Administration by the end of the year and anticipates completing all approvals by the beginning of next year. Patient recruitment will span six months and the first patient visit is expected to happen in May 2025. The study is anticipated to be completed by the end of 2026.
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