Ainos Announced Plan to Initiate Taiwan Clinical Study of VELDONA for Treating Sjögren's Syndrome, a Rare Disease With Limited Treatment Options
Ainos (NASDAQ:AIMD) has announced plans to conduct a Taiwan clinical study for VELDONA in treating Sjögren's syndrome, a rare autoimmune disease. The study, to be conducted at Taipei Medical University-Shuang Ho Hospital, aims to recruit 24 patients who will take three sublingual VELDONA tablets daily for 24-48 weeks. The primary objective is to evaluate VELDONA's efficacy in improving saliva secretion and dryness symptoms.
The company has previously conducted eight clinical trials in the U.S., including three Phase 3 studies that showed positive benefits in increasing unstimulated whole saliva secretion without significant adverse effects. Ainos expects to complete all regulatory approvals for the Taiwan study by November 2024, with patient enrollment lasting approximately six months. The study is projected to conclude in January 2026.
Ainos (NASDAQ:AIMD) ha annunciato piani per condurre uno studio clinico in Taiwan per VELDONA nel trattamento della sindrome di Sjögren, una rara malattia autoimmune. Lo studio, che si svolgerà presso il Taipei Medical University-Shuang Ho Hospital, mira a reclutare 24 pazienti che assumeranno tre compresse sublinguali di VELDONA al giorno per un periodo di 24-48 settimane. L'obiettivo principale è valutare l'efficacia di VELDONA nel migliorare la secrezione salivare e i sintomi di secchezza.
L'azienda ha precedentemente condotto otto studi clinici negli Stati Uniti, inclusi tre studi di Fase 3 che hanno mostrato benefici positivi nell'aumentare la secrezione di saliva intera non stimolata senza effetti avversi significativi. Ainos si aspetta di completare tutte le approvazioni regolatorie per lo studio in Taiwan entro novembre 2024, con un reclutamento di pazienti che durerà circa sei mesi. Si prevede che lo studio si concluda a gennaio 2026.
Ainos (NASDAQ:AIMD) ha anunciado planes para llevar a cabo un estudio clínico en Taiwán para VELDONA en el tratamiento del sindrome de Sjögren, una enfermedad autoinmunitaria rara. El estudio, que se realizará en el Taipei Medical University-Shuang Ho Hospital, tiene como objetivo reclutar a 24 pacientes que tomarán tres tabletas sublinguales de VELDONA al día durante 24-48 semanas. El objetivo principal es evaluar la eficacia de VELDONA en la mejora de la secreción salival y los síntomas de sequedad.
La empresa ha llevado a cabo previamente ocho ensayos clínicos en EE.UU., incluidos tres estudios de Fase 3 que mostraron beneficios positivos en el aumento de la secreción de saliva total no estimulada sin efectos adversos significativos. Ainos espera completar todas las aprobaciones regulatorias para el estudio en Taiwán para noviembre de 2024, con la inscripción de pacientes que durará aproximadamente seis meses. Se proyecta que el estudio concluirá en enero de 2026.
Ainos (NASDAQ:AIMD)는 타이완 임상 연구를 실시할 계획을 발표했습니다. 이 연구는 드문 자가면역 질환인 쇼그렌 증후군 치료를 위한 VELDONA를 대상으로 하고 있습니다. 연구는 타이페이 의과대학-수앙 호 병원에서 진행되며, 24명의 환자를 모집하여 24-48주 동안 매일 3개의 VELDONA 설하 정제를 복용할 예정입니다. 주요 목표는 VELDONA의 효과를 평가하여 타액 분비와 건조 증상을 개선하는 것입니다.
회사는 이전에 미국에서 8개의 임상 시험을 실시했으며, 그 중 3개의 3상 연구에서 유의미한 부작용 없이 자극되지 않은 전체 타액 분비 증가에서 긍정적인 결과를 보였습니다. Ainos는 2024년 11월까지 타이완 연구에 대한 모든 규제 승인을 완료할 것으로 예상하며, 환자 등록은 약 6개월 동안 진행될 것입니다. 연구는 2026년 1월에 종료될 것으로 예상됩니다.
Ainos (NASDAQ:AIMD) a annoncé ses projets de réaliser une étude clinique à Taïwan pour VELDONA dans le traitement du syndrome de Sjögren, une maladie auto-immune rare. L'étude, qui se déroulera à l'hôpital de l'université médicale de Taipei-Shuang Ho, vise à recruter 24 patients qui prendront trois comprimés sublinguaux de VELDONA par jour pendant 24 à 48 semaines. L'objectif principal est d'évaluer l'efficacité de VELDONA dans l'amélioration de la sécrétion salivaire et des symptômes de sécheresse.
La société a précédemment mené huit essais cliniques aux États-Unis, y compris trois études de phase 3 qui ont montré des bénéfices positifs dans l'augmentation de la sécrétion de salive totale non stimulée sans effets secondaires significatifs. Ainos s'attend à obtenir toutes les approbations réglementaires pour l'étude de Taïwan d'ici novembre 2024, avec un recrutement de patients qui durera environ six mois. L'étude devrait se terminer en janvier 2026.
Ainos (NASDAQ:AIMD) hat Pläne angekündigt, eine klinische Studie in Taiwan für VELDONA zur Behandlung des Sjögren-Syndroms, einer seltenen Autoimmunerkrankung, durchzuführen. Die Studie, die am Taipei Medical University-Shuang Ho Hospital durchgeführt wird, zielt darauf ab, 24 Patienten zu rekrutieren, die täglich drei sublinguale VELDONA-Tabletten über einen Zeitraum von 24-48 Wochen einnehmen. Das Hauptziel besteht darin, die Wirksamkeit von VELDONA bei der Verbesserung der Speichelsekretion und der Trockenheitssymptome zu bewerten.
Das Unternehmen hat zuvor bereits acht klinische Studien in den USA durchgeführt, darunter drei Phase-3-Studien, die positive Vorteile bei der Steigerung der ungestillten gesamten Speichelsekretion ohne signifikante Nebenwirkungen gezeigt haben. Ainos erwartet, alle behördlichen Genehmigungen für die Taiwan-Studie bis November 2024 abzuschließen, wobei die Patientenrekrutierung etwa sechs Monate in Anspruch nehmen wird. Die Studie soll voraussichtlich im Januar 2026 abgeschlossen werden.
- Prior Phase 3 studies showed positive benefits in increasing unstimulated whole saliva secretion without significant adverse effects
- The global market for Sjögren's syndrome treatment is projected to grow at a CAGR of 4.2% from 2023 to 2030
- Ainos is optimistic about VELDONA's potential to improve quality of life for people with primary Sjögren's syndrome
- The second Phase 3 study showed only a trend toward increased unstimulated whole saliva, not reaching statistical significance
Prior Phase 3 studies showed positive benefits in increasing unstimulated whole saliva secretion
Ainos aims to complete all regulatory approvals for the study in Q4 2024
SAN DIEGO, CA / ACCESSWIRE / September 23, 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, is pleased to announce that it plans to conduct a Taiwan clinical study for very low-dose interferon alpha (VELDONA) on treating Sjögren's syndrome at Taipei Medical University-Shuang Ho Hospital. A total of eight clinical trials have been conducted in the U.S. by the Company to evaluate the use of VELDONA® for treating Sjögren's syndrome. Three Prior Phase 3 studies show positive benefits in increasing unstimulated whole saliva secretion without significant adverse effects.
Disease overview
Sjögren's syndrome is an autoimmune disease in which the body's immune system mistakenly attacks its own tissues. The disease can be classified as primary (without associated autoimmune diseases) or secondary (associated with conditions such as lupus, rheumatoid arthritis, and systemic sclerosis). The global prevalence of Sjögren's syndrome is estimated to be 1 to 4 per 1,000 people, with approximately 90,000 patients in Taiwan. The disease primarily affects middle-aged women between 40 and 60 years old, 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 between 400,000 to 3.1 million adults globally, with an average onset age of 45 to 55 years.
The global market for Sjögren's syndrome treatment is projected to grow at a compound annual growth rate of
Clinical Study Design and Objectives
The upcoming study will be conducted by the Allergy, Immunology, and Rheumatology Department at Shuang Ho Hospital. The trial will follow the diagnostic criteria established by the American College of Rheumatology and the European League Against Rheumatism in 2016, aiming to recruit 24 patients. Each participant will take three sublingual tablets of VELDONA® daily for 24 to 48 weeks.
The primary objective is to evaluate the efficacy of VELDONA® in improving saliva secretion and dryness symptoms in patients with primary Sjögren's syndrome.
Secondary objectives include:
1. Measuring the change in the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) for dryness symptoms on a scale from 0 to 10 (0 = no symptoms, 10 = worst imaginable symptoms);
2. Evaluating changes in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI);
3. Assessing improvements in oral and ocular symptoms using a visual analog scale (VAS) for eight dryness-related items;
4. Monitoring salivary gland function using a nuclear medicine salivary gland scan.
Study Timeline and Progress
ComboTrial Consultancy Ltd., a contract research organization certified by the Taiwan Food and Drug Administration (TFDA), will manage the clinical trial.
Institutional Review Board (IRB) submission has been completed at Shuang Ho Hospital. TFDA approval is expected to be submitted in October, 2024. The trial is anticipated to complete all regulatory approvals by November 2024, with a site initiation meeting (SIV) and first patient visit (FPFV) projected for December 2024.
The patient enrollment will last approximately six months, with the last patient's first visit (LPFV) expected by May 2025, and the last patient's last visit (LPLV) by November 2025. The study is expected to conclude in January 2026.
Prior VELDONA® Studies:
A total of eight clinical trials have been conducted by the Company for evaluating VELDONA® for treating Sjögren's syndrome in the U.S., including three Phase 3 trials. Three prior Phase 3 clinical trials demonstrated promising results in improving oral dryness symptoms without significant adverse effects.
1. First Study: A total of 241 patients were randomized in a 24-week double-blind, placebo-controlled study. Patients were given either placebo or 150 IU HBL IFNα three times daily. Results showed a significant increase in unstimulated whole saliva (p<0.05) in the treatment group compared to the placebo group. No other significant treatment effects were observed. There were no serious adverse events or deaths, and no significant differences in adverse event rates or severity between the groups.
2. Second Study: This 24-week double-blind, placebo-controlled trial included 256 patients. The treatment group showed a trend toward increased unstimulated whole saliva (p<0.10), but it did not reach statistical significance. No serious adverse events were reported, and safety profiles between the treatment and placebo groups were similar.
3. Third Study: A total of 288 patients participated in a 48-week open-label safety study. All patients received 150 IU HBL IFNα three times daily. By the end of the treatment, patients experienced significant improvements in oral dryness and comfort (p<0.0001), along with significant improvements in all eight dryness symptoms assessed (p<0.05). No serious adverse events were observed, and no clinically significant changes in safety parameters were detected.
"Based on these findings, Ainos is optimistic about VELDONA®'s potential to improve the quality of life for people living with primary Sjögren's syndrome and believes it may become a valuable treatment option for the condition," Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented.
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 low-dose interferon therapeutics (VELDONA). 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 Statement
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
Contact Information
Feifei Shen
ir@ainos.com
SOURCE: Ainos, Inc.
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FAQ
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