Ainos Announces IRB Approval for Sjögren’s Syndrome Clinical Study at Shuang Ho Hospital, Affiliated with Taipei Medical University, and Plans to Initiate New Phase of Treatment Evaluation in Q1 2025
Ainos (NASDAQ:AIMD) has received IRB approval from Shuang Ho Hospital for its clinical trial of VELDONA® in treating Sjögren's syndrome. The company plans to commence a site initiation visit around April 2025, pending regulatory approvals. The study will recruit 24 patients for a 24- to 48-week treatment period. Previous U.S. clinical trials, including three Phase 3 studies, demonstrated VELDONA® significantly increases unstimulated whole salivary flow. The trial's primary endpoint is to evaluate VELDONA®'s efficacy in improving salivary flow and alleviating dryness symptoms. Patient recruitment will begin in May 2025, with study completion expected by December 2026.
Ainos (NASDAQ:AIMD) ha ricevuto l'approvazione IRB dall'Ospedale Shuang Ho per il suo studio clinico su VELDONA® nel trattamento della sindrome di Sjögren. L'azienda prevede di iniziare una visita per l'avvio del sito intorno a aprile 2025, in attesa delle approvazioni regolatorie. Lo studio recluterà 24 pazienti per un periodo di trattamento da 24 a 48 settimane. I precedenti studi clinici negli Stati Uniti, compresi tre studi di Fase 3, hanno dimostrato che VELDONA® aumenta significativamente il flusso salivare totale non stimolato. L'obiettivo principale dello studio è valutare l'efficacia di VELDONA® nel migliorare il flusso salivare e alleviare i sintomi di secchezza. Il reclutamento dei pazienti inizierà a maggio 2025, con completamento dello studio previsto entro dicembre 2026.
Ainos (NASDAQ:AIMD) ha recibido la aprobación IRB del Hospital Shuang Ho para su ensayo clínico de VELDONA® en el tratamiento del síndrome de Sjögren. La compañía planea llevar a cabo una visita de inicio de sitio alrededor de
Ainos (NASDAQ:AIMD)는 Sjögren 증후군 치료를 위한 VELDONA®의 임상 시험에 대해 Shuang Ho 병원으로부터 IRB 승인을 받았습니다. 이 회사는 규제 승인이 남아 있는 상태에서 2025년 4월에 현장 개시 방문을 시작할 계획입니다. 이번 연구는 24주에서 48주 동안 24명의 환자를 모집할 예정입니다. 이전의 미국 임상 시험, 특히 세 개의 3상 연구에서 VELDONA®가 자극 없는 전체 타액 흐름을 유의미하게 증가시키는 것으로 나타났습니다. 시험의 주요 목표는 VELDONA®의 효과를 평가하여 타액 흐름을 개선하고 건조 증상을 완화하는 것입니다. 환자 모집은 2025년 5월에 시작되며, 연구 완료는 2026년 12월로 예상됩니다.
Ainos (NASDAQ:AIMD) a obtenu l'approbation IRB de l'hôpital Shuang Ho pour son essai clinique sur VELDONA® dans le traitement du syndrome de Sjögren. La société prévoit de commencer une visite d'initiation de site vers avril 2025, en attente des approbations réglementaires. L'étude recrutera 24 patients pour une période de traitement de 24 à 48 semaines. Les essais cliniques précédents aux États-Unis, y compris trois études de Phase 3, ont démontré que VELDONA® augmente significativement le flux salivaire total non stimulé. L'objectif principal de l'essai est d'évaluer l'efficacité de VELDONA® dans l'amélioration du flux salivaire et le soulagement des symptômes de sécheresse. Le recrutement des patients débutera en mai 2025, avec une fin d'étude prévue d'ici décembre 2026.
Ainos (NASDAQ:AIMD) hat die IRB-Genehmigung des Shuang Ho Krankenhauses für seine klinische Studie zu VELDONA® zur Behandlung des Sjögren-Syndroms erhalten. Das Unternehmen plant, rund um April 2025 einen Startbesuch am Standort vorzunehmen, vorbehaltlich der regulatorischen Genehmigungen. Die Studie wird 24 Patienten für einen Behandlungszeitraum von 24 bis 48 Wochen rekrutieren. Frühere klinische Studien in den USA, einschließlich dreier Phase-3-Studien, haben gezeigt, dass VELDONA® den nicht stimulierten gesamten Speichelfluss signifikant erhöht. Das Hauptziel der Studie besteht darin, die Wirksamkeit von VELDONA® bei der Verbesserung des Speichelflusses und der Linderung von Trockenheitssymptomen zu bewerten. Die Rekrutierung von Patienten beginnt im Mai 2025, und mit einem Studienabschluss wird bis Dezember 2026 gerechnet.
- Previous Phase 3 trials showed significant improvement in oral dryness symptoms
- No serious adverse reactions reported in previous clinical trials
- Global Sjögren's syndrome treatment market expected to grow at 4.2% CAGR through 2030
- Second study results didn't reach statistical significance (p<0.10)
- Extended timeline with study completion not expected until end of 2026
Insights
This clinical trial announcement represents a significant milestone for Ainos' VELDONA treatment for Sjögren's syndrome. The IRB approval and detailed trial design demonstrate strong scientific rigor with clear endpoints. Previous Phase 3 data showing significant improvements in salivary flow and symptom relief without serious adverse events provides compelling evidence for VELDONA's potential.
The market opportunity is substantial, with
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
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
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.
Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date.
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: IR@ainos.com
SOURCE: Ainos, Inc.
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FAQ
When will Ainos (AIMD) begin patient recruitment for the Sjögren's syndrome VELDONA trial?
What were the results of AIMD's previous VELDONA clinical trials for Sjögren's syndrome?
How many patients will be enrolled in AIMD's new Sjögren's syndrome trial at Shuang Ho Hospital?
