Ainos, Inc. Receives IRB Approval From National Taiwan University Hospital for HIV-Oral Warts Clinical Trial, Highlighting Value of FDA-Designated Orphan Drug VELDONA
Rhea-AI Summary
Ainos, Inc. (NASDAQ:AIMD) has received Institutional Review Board (IRB) approval from the National Taiwan University Hospital for its clinical trial on VELDONA®, a low-dose oral interferon formulation for treating oral warts in HIV-positive patients. The trial, involving 40 participants, will evaluate VELDONA®'s efficacy in combination with antiretroviral therapy. VELDONA® has received orphan drug designation from the FDA, highlighting its potential in addressing an unmet medical need.
The next step is obtaining approval from the Taiwan Food and Drug Administration (TFDA). The application was submitted on August 28, 2024. The Site Initiation Visit is expected in November 2024, with patient enrollment lasting one year. The study is anticipated to conclude by July 2026.
Positive
- Received IRB approval for VELDONA® clinical trial
- FDA orphan drug designation for VELDONA®
- Potential to address unmet medical need for HIV-related oral warts
- Trial to enroll 40 participants, evaluating efficacy over 24 weeks
Negative
- TFDA approval still pending before trial can begin
- Study not expected to conclude until July 2026
Insights
The IRB approval from National Taiwan University Hospital for Ainos' VELDONA® clinical trial is a significant milestone. This study, focusing on HIV-related oral warts, addresses an unmet medical need affecting a substantial portion of the 39.9 million people living with HIV globally. The orphan drug designation from the FDA for VELDONA® is particularly noteworthy, as it offers:
- Accelerated regulatory pathway
- Potential for market exclusivity
- Enhanced commercial viability
The trial design, involving 40 participants over 24 weeks, is robust and could provide valuable efficacy data. If successful, this oral interferon therapy could offer a more convenient treatment option for HIV patients with oral warts, potentially improving quality of life and treatment adherence. However, investors should note that the trial's completion is not expected until July 2026, indicating a long timeline before potential commercialization.
Ainos' progress with VELDONA® demonstrates strategic positioning in the orphan drug market, a sector known for high growth potential and premium pricing. The oral administration of VELDONA® could provide a competitive edge over injectable alternatives, potentially leading to better patient compliance and market penetration. However, several factors warrant investor attention:
- The small patient population (35,500 HIV patients in Taiwan) may limit initial market size
- Pending TFDA approval is important for trial commencement
- Long development timeline (completion in 2026) may impact short-term investor returns
Despite these challenges, the orphan drug status and potential for global expansion could offer significant long-term value. Investors should monitor the upcoming TFDA decision and patient enrollment progress as key indicators of VELDONA®'s development trajectory and Ainos' ability to execute its clinical strategy.
Next step will be receiving approval from Taiwan Food and Drug Administration (TFDA)
SAN DIEGO, CA / ACCESSWIRE / September 25, 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 it has received Institutional Review Board (IRB) approval from the National Taiwan University Hospital for its clinical trial focused on treating oral warts in HIV-positive patients. This trial will evaluate VELDONA®, Ainos' low-dose oral interferon formulation, which has received orphan drug designation from the U.S. Food and Drug Administration ("FDA"), as a potential treatment for HIV-related oral warts.
VELDONA®, as an oral interferon therapy, is recognized for its potential efficacy and patient convenience, particularly in treating rare diseases. The FDA's orphan drug designation not only highlights the drug's promise in addressing HIV-related oral warts but also offers significant regulatory advantages, accelerating its path to commercialization to meet an unmet medical need.
Oral warts are a common complication in HIV-positive patients, severely impacting their quality of life. According to UNAIDS, in 2023 there were approximately 39.9 million people living with HIV globally, with 1.3 million new infections and 630,000 AIDS-related deaths. In Taiwan, there were around 35,500 individuals living with HIV and 940 reported new cases in 2023. There were 666 new reported cases as of August 2024.
Clinical Trial Overview
The clinical trial, titled "Evaluation of Human Interferon Alpha Administered Oromucosally in the Treatment of Oral Warts in HIV-Seropositive Subjects Receiving Combination Anti-Retroviral Therapy" (Protocol No.: 03HUHI19), will be conducted as a single-site study at the National Taiwan University Hospital. The trial was submitted for IRB review on June 27, 2024, and received formal approval on September 18, 2024 (NTUH-REC No.: 202407046MSB).
The study will enroll 40 HIV-positive participants, who will be randomly assigned in a 1:3 ratio to either the VELDONA® group or a placebo group. Participants will take 10 sublingual tablets of VELDONA® or placebo daily for 24 weeks. The primary and secondary endpoints of the trial are to evaluate the efficacy of VELDONA® in combination with antiretroviral therapy compared to placebo in treating oral warts in HIV-positive patients.
Orphan Drug Value and Future Plans
As an FDA-designated orphan drug, VELDONA® not only holds significant clinical potential but also offers a convenient oral administration method, especially beneficial for patients requiring long-term or chronic treatment. The successful initiation of this clinical trial represents a key milestone in the global development of VELDONA® for the treatment of HIV-related oral warts.
Before the trial can officially begin, an approval from Taiwan Food and Drug Administration (TFDA) is required. Ainos has already submitted the application through Bestat Pharmaservices Corporation, a TFDA-certified Contract Research Organization (CRO), on August 28, 2024. The Site Initiation Visit (SIV) is expected to take place in November 2024, with patient enrollment anticipated to last one year. The study is expected to conclude by July 2026.
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.
Contact Information
Feifei Shen
ir@ainos.com
Contact Information
Feifei Shen
ir@ainos.com
SOURCE: Ainos, Inc.
View the original press release on accesswire.com
FAQ
What is the purpose of Ainos' VELDONA® clinical trial for HIV-related oral warts?
When is the VELDONA® clinical trial (AIMD) expected to begin and end?
What is the significance of FDA orphan drug designation for VELDONA® (AIMD)?
How many participants will be involved in the VELDONA® clinical trial for HIV-oral warts (AIMD)?
