Water Tower Research Highlights Ainos VELDONA Clinical Trial for HIV+ Patients with Oral Warts

Rhea-AI Summary

Ainos, Inc. (NASDAQ:AIMD) has announced a new clinical trial for VELDONA®, its low-dose oral interferon-alpha formulation, to treat oral warts in HIV+ patients on antiretroviral therapy. Water Tower Research has issued a report highlighting key aspects of this upcoming trial:

1. The single-site, double-blind study will commence at the National Taiwan University Hospital by November 2024.

2. The trial will enroll 40 subjects, randomized 3:1 to VELDONA® or placebo.

3. The primary endpoint is a 75% reduction in oral wart surface area over 24 weeks.

4. VELDONA® has received Orphan Drug Designation from the FDA for this indication.

5. The study aligns with Ainos' capital-efficient strategy, as clinical studies in Taiwan are less costly than in the U.S.

6. There are currently no approved therapeutics for oral warts, which affect approximately 49,000 HIV+ patients in the U.S.

Positive

• VELDONA® received Orphan Drug Designation from the FDA for treating oral warts in HIV+ patients
• Previous Phase 2 trial in the U.S. showed promising results for VELDONA®
• The clinical trial aligns with Ainos' capital-efficient strategy due to lower costs in Taiwan
• Addresses an unmet medical need with no currently approved therapeutics for oral warts in HIV+ patients

Negative

• The clinical trial is subject to approval by NTUH and Taiwan Food and Drug Administration
• The study is not expected to complete until July 2026, indicating a long timeline for potential results

Insights

Medical Research Analyst

The upcoming VELDONA® clinical trial for treating oral warts in HIV+ patients represents a significant step in addressing an unmet medical need. With 49,000 affected patients in the U.S. and no FDA-approved treatments, this trial could pave the way for a novel therapeutic option. The previous Phase 2 results showing VELDONA®'s superiority over placebo are encouraging. The primary endpoint of 75% reduction in oral wart surface area is ambitious but achievable based on earlier data. The Orphan Drug Designation could expedite the approval process if results are positive. However, the small sample size of 40 subjects and single-site nature of the study may limit its statistical power and generalizability. The 2026 completion date suggests a long-term investment horizon for potential commercialization.

Financial Analyst

Ainos' strategy of conducting the VELDONA® trial in Taiwan demonstrates cost-efficiency, potentially stretching their R&D budget further. This approach could conserve cash and extend the company's runway, which is important for small biotech firms. The Orphan Drug Designation provides market exclusivity if approved, potentially boosting future revenues. However, investors should note the extended timeline to 2026 for trial completion, indicating a long path to potential commercialization. The focus on a niche market (HIV+ patients with oral warts) suggests a but potentially lucrative market if successful. The company's dual focus on POCT and therapeutics diversifies risk but may also spread resources thin. Overall, while promising, this news represents an early-stage development with significant time and regulatory hurdles ahead.

Market Research Analyst

The VELDONA® trial targets a niche but underserved market with potential for expansion. The lack of approved treatments for oral warts in HIV+ patients presents a clear market opportunity. If successful, Ainos could capture a significant portion of this market. The dual approach of POCT and therapeutics positions the company uniquely in the healthcare sector. However, the small target population may limit overall market size and potential revenue. The long timeline to market entry could allow competitors to develop alternative treatments. The cost-efficient approach to clinical trials in Taiwan is commendable, but may raise questions about data applicability to U.S. populations. Investors should consider the balance between the potential market opportunity and the risks associated with drug development in this specialized field.

SAN DIEGO, CA / ACCESSWIRE / September 20, 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 Water Tower Research ("WTR") has issued a note on the Company's upcoming clinical trial for VELDONA^®, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV+ patients on antiretroviral therapy ("ART").

The report highlights Ainos' commitment to advancing cost-efficient clinical research alongside a single-site, double-blind study set to commence at the National Taiwan University Hospital ("NTUH") by November 2024. The trial, designed to enroll 40 subjects, randomized 3:1 to VELDONA^® or placebo, aims to assess the efficacy of VELDONA^® in reducing the surface area of oral warts. The study's primary endpoint is an at least 75% reduction in oral wart surface area over 24 weeks, alongside secondary endpoints of a minimum reduction of 50% and patient- and physician-assessed quality of oral health.

Key Highlights from the Report:

• VELDONA^® Clinical Trial: The clinical study is subject to Investigational Review Board approval by NTUH and Taiwan Food and Drug Administration, with expectations to complete by July 2026 at a one-year patient enrollment. This trial is in alignment with Ainos' capital efficient strategy as clinical studies in Taiwan cost less in comparison to that in the U.S.

• Positive Phase 2 Data: A previous Phase 2 trial conducted in the U.S. demonstrated promising results, with VELDONA^® outperforming the placebo in reducing the area of oral warts in HIV+ patients.

• Orphan Drug Designation: VELDONA^® has received Orphan Drug Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of oral warts in HIV+ patients, a group with limited therapeutic options.

• Unmet Medical Need: There are no approved therapeutics for oral warts, which affect approximately 49,000 HIV+ patients in the U.S. alone. Current treatments, including surgical excision, carry risks of recurrence and progression to more serious conditions, underscoring the critical need for new treatment options like VELDONA^®.

Link to the WTR report

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

SOURCE: Ainos, Inc.

View the original press release on accesswire.com

FAQ

What is the purpose of Ainos' VELDONA clinical trial for HIV+ patients with oral warts?

The VELDONA clinical trial aims to assess the efficacy of the low-dose oral interferon-alpha formulation in reducing the surface area of oral warts in HIV+ patients on antiretroviral therapy.

When is Ainos (AIMD) expected to start the VELDONA clinical trial?

Ainos (AIMD) is expected to start the VELDONA clinical trial by November 2024 at the National Taiwan University Hospital.

What is the primary endpoint of Ainos' VELDONA clinical trial?

The primary endpoint of Ainos' VELDONA clinical trial is an at least 75% reduction in oral wart surface area over 24 weeks.

Has VELDONA received any special designations from the FDA for Ainos (AIMD)?

Yes, VELDONA has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of oral warts in HIV+ patients.