IRB approval on track as scheduled
Next step is obtaining all regulatory approvals, followed by site initiation visit
VELDONA significantly increases unstimulated whole salivary flow in prior Phase 3 studies
SAN DIEGO, CA / ACCESSWIRE / November 11, 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 it has received Institutional Review Board ("IRB") approval from Shuang Ho Hospital, affiliated with Taipei Medical University (IRB Approval No.: TMU-JIRB No.: N202408042), for its clinical trial of VELDONA® in treating Sjögren's syndrome. Ainos plans to commence a site initiation visit ("SIV") for the study around April 2025, subject to regulatory approvals. The study aims to further assess the potential of VELDONA® in improving salivary gland function and alleviating symptoms of dryness. Ainos previously conducted eight clinical studies in the U.S., including three Phase 3 trials, showing that VELDONA® significantly increases unstimulated whole salivary flow.
"We are thrilled to receive IRB approval of our clinical study in Taiwan as scheduled. Given the previous clinical trials, we are enthusiastic about VELDONA®'s potential to enhance life quality for patients with Sjögren's syndrome. We look forward to positioning VELDONA®as a breakthrough treatment option," Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos, commented.
Disease Overview:
Sjögren's syndrome is an autoimmune disease in which the body mistakenly attacks its own tissues, perceiving them as "foreign invaders." First identified and named by Swedish physician Henrik Sjögren in 1933, the disease can be classified as either primary (without concurrent autoimmune disorders) or secondary (coexisting with other autoimmune diseases such as lupus and rheumatoid arthritis). The global prevalence is estimated to be between 0.1% and 0.4%, with approximately 90,000 patients in Taiwan, primarily affecting middle-aged women aged 40 to 60, 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 approximately 400,000 to 3.1 million adults, with an average onset age of 45 to 55 years.
The global market for treating Sjögren's syndrome is expected to grow at a compound annual growth rate (CAGR) of 4.2% through 2030.
Clinical Trial Design and Objectives:
The study will be conducted at Shuang Ho Hospital under the oversight of the Department of Allergy, Immunology, and Rheumatology. Its primary endpoint is to evaluate the efficacy of VELDONA® in improving salivary flow and alleviating dryness symptoms in patients with primary Sjögren's syndrome. The trial follows an open-label design (Protocol Title: An open-label study to evaluate the efficacy of VELDONA® in patients with primary Sjögren's syndrome) and will recruit 24 patients for a 24- to 48-week treatment period, based on the diagnostic criteria established by the American and European Rheumatology Associations in 2016.
Secondary endpoints include:
Assessing improvements in dryness symptoms using the European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI);
Measuring changes in disease activity using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI);
Evaluating eight specific dryness symptoms, including oral and ocular dryness, using the Visual Analog Scale (VAS);
Conducting nuclear medicine imaging to compare pre- and post-treatment salivary gland function.
Clinical Trial Timeline and Progress:
The trial is managed by ComboTrial Consultancy Ltd. under Good Clinical Practice (GCP) standards. Following the IRB approval from Shuang Ho Hospital (TMU-JIRB No.: N202408042), Ainos plans to submit to Taiwan's Food and Drug Administration (TFDA) by the end of December 2024 and anticipates to complete all approvals by Q1 2025, with the SIV scheduling for April 2025. Patient recruitment will span six months, with the First Patient First Visit (FPFV) anticipated for May 2025, the Last Patient Last Visit (LPLV) by the end of November 2025, and study completion by the end of December 2026.
Potential Benefits of VELDONA® from Prior Clinical Data:
Ainos has previously conducted three clinical trials in the U.S. evaluating VELDONA® for Sjögren's syndrome. Results indicate the product has the potential to significantly improve oral dryness symptoms without serious adverse reactions.
First Study: A total of 241 patients participated in a 24-week double-blind, placebo-controlled study, where patients were randomly assigned to receive either a placebo or 150 IU of HBL IFNα three times daily. Results showed a significant increase in unstimulated whole salivary flow (p<0.05) in the HBL IFNα group, with no other significant treatment effects observed. There were no reports of serious adverse reactions or deaths during the study, and no statistically significant difference in the incidence or severity of adverse events between the treatment and placebo groups.
Second Study: In a similar 24-week double-blind, placebo-controlled study with 256 patients, the difference in salivary flow between the treatment and placebo groups was assessed. Results indicated a trend toward increased unstimulated whole salivary flow in the 150 IU HBL IFNα treatment group (p<0.10), although this did not reach statistical significance. The incidence and severity of adverse events were comparable between the treatment and placebo groups.
Third Study: A 48-week open-label safety study was conducted with 288 patients, all of whom received 150 IU HBL IFNα three times daily. By the end of the treatment period, patients reported significant improvement in oral dryness and comfort (p<0.0001), with significant improvements observed in all eight symptom scores (p<0.05). No treatment-related serious adverse reactions were noted, and the safety analysis indicated no clinically significant changes.
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 VELDONA low-dose interferon therapeutics. 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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Safe Harbor Statements
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements can be identified by the use of words such as "anticipate," "believe," "estimate," "approximate," "expect," "intend," "plan," "predict," "project," "target," "future," "likely," "strategy," "foresee," "may," "guidance," "potential," "outlook," "forecast," "should," "will" or other similar words or phrases. Similarly, statements that describe the Company's objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company's current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company's control. The Company's actual results may differ materially from those indicated in the forward-looking statements.
Important factors that could cause the Company's actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the products announced in this press release; the Company's dependence on projected revenues from the sale of current or future products; the Company's limited cash and history of losses; the Company's ability to achieve profitability; the Company's ability to raise additional capital to continue the Company's product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos' current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos' product candidates; delays in completing the development and commercialization of the Company's current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company's industry that may outpace its technology; customer demand for the products and services the Company develops; the accuracy of third-party market research data, the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company's ability to realize the benefits of third party licensing agreements; the Company's ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company's success in managing growth. A more complete description of these risk factors and others is included in the "Risk Factors" section of Ainos' Annual Report on Form 10-K for the year ended December 31, 2023, and other public filings with the U.S. Securities and Exchange Commission ("SEC"), many of which risks are beyond the Company's control. In addition to the risks described above and in the Company's filings with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.
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.
Investor Relations Contact
Feifei Shen
Email: [email protected]
SOURCE: Ainos, Inc.