Ainos Announced Plan to Initiate Taiwan Clinical Study for VELDONA as Potential Treatment of Oral Warts in HIV-Seropositive Patients, an Orphan Drug Designated by the FDA

Rhea-AI Summary

Ainos (NASDAQ:AIMD) has announced plans to initiate a clinical study for VELDONA, a low-dose oral interferon-alpha formulation, as a potential treatment for oral warts in HIV-positive patients. The study will be conducted at National Taiwan University Hospital, involving 40 participants in a double-blind trial lasting 24 weeks. VELDONA has received Orphan Drug Designation from the U.S. FDA for this indication.

The study aims to evaluate the efficacy of VELDONA in reducing oral wart surface area, with a successful response defined as a 75% or greater reduction. Previous U.S. trials involving 77 HIV-positive patients showed significant reductions in oral wart surface area, with decreases of over 75% and up to 99% in some cases. The study is expected to begin in November 2024 and conclude in July 2026.

Positive

• VELDONA received Orphan Drug Designation from the U.S. FDA for treating oral warts in HIV-positive patients
• Previous U.S. trials showed significant reductions in oral wart surface area, with decreases of over 75% and up to 99%
• The clinical study will be conducted at a premier Taiwanese medical center for HIV management
• The study protocol is under review for IRB approval by National Taiwan University Hospital and Taiwan FDA

Negative

• Patient enrollment is projected to take one year, potentially delaying results
• Study completion is not expected until July 2026, which may impact the timeline for potential market entry
• Currently, there are no established pharmacological therapies for HIV-related oral warts, indicating potential challenges in market acceptance

Insights

Medical Research Analyst

This clinical study for VELDONA in HIV-related oral warts is a significant step forward in addressing an unmet medical need. The orphan drug designation by the FDA underscores the potential impact of this treatment. Key points:

• The study's design (40 participants, 1:3 randomization, 24-week duration) is robust for initial efficacy assessment.
• Primary endpoint of 75% reduction in wart surface area is clinically meaningful.
• Previous studies showed promising results with up to 99% reduction in some cases.
• The lack of established pharmacological therapies for HIV-related oral warts highlights the potential value of VELDONA if successful.

While the study size is relatively small, positive results could pave the way for larger trials and potentially fill a significant treatment gap for HIV patients.

Financial Analyst

The initiation of this clinical study represents a positive development for Ainos (NASDAQ:AIMD). Key financial implications:

• Orphan Drug Designation provides market exclusivity and potential tax credits, enhancing the commercial viability of VELDONA.
• The global HIV patient population of 39.9 million represents a substantial market opportunity, even if targeting a subset with oral warts.
• Collaboration with a premier Taiwanese medical center adds credibility and could facilitate future partnerships or market access.
• The timeline (study completion in July 2026) suggests a medium-term horizon for potential revenue impact.

While the study's success is not guaranteed, positive results could significantly boost Ainos' market position and valuation in the biotech sector.

Ainos Plans To Conduct the Study at National Taiwan University Hospital, a Premier Taiwanese Medical Center for HIV Management

The U.S. FDA Have Granted Orphan Drug Designation (ODD) for the Company's VELDONA^® Low-Dose Oral Interferon Formulation as a Potential Treatment for Oral Warts in HIV-Positive Patients

SAN DIEGO, CA / ACCESSWIRE / September 17, 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 its plans to initiate a clinical study for very low-dose interferon alpha (VELDONA) on treating Human immunodeficiency virus (HIV)-related oral warts at the National Taiwan University Hospital. The study aims to evaluate the efficacy of VELDONA^®, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV-positive patients undergoing combination antiretroviral therapy. VELDONA^® has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for this indication, offering new hope to HIV-positive individuals suffering from oral warts.

Overview of the Clinical Study

This clinical study will be conducted by the Infectious Disease Department at National Taiwan University Hospital, one of Taiwan's 25 designated medical centers for HIV management. The hospital oversees nearly 4,000 HIV-positive patients, approximately 11.2% of Taiwan's total HIV cases. The study will enroll 40 participants who will be randomized in a 1:3 ratio to receive either a placebo or VELDONA^® in a double-blind trial. Participants will take VELDONA^® or a placebo sublingually every day for 24 weeks.

The primary objective of the study is to evaluate the reduction in oral warts' surface area. A successful response is defined as a reduction of 75% or more in the surface area of oral warts compared to baseline, while a non-responsive result indicates less than 75% reduction.

The secondary objectives include evaluating oral wart surface area reduction by 50% or more, as well as participant self-assessments through questionnaires comparing oral health to baseline conditions. The study's Principal Investigator (PI) will also objectively assess the participants' oral conditions.

This clinical study will be conducted in accordance with Good Clinical Practice (GCP) guidelines by Bestat Pharmaservices Corporation, a TFDA-certified Contract Research Organization (CRO). The study is expected to begin in November 2024, with the first patient visit (FPFV) anticipated in November. Patient enrollment is projected to take one year, with the last patient visit (LPLV) expected in May 2026, and study completion anticipated in July 2026. Protocol of the study is currently being reviewed for Investigational Review Board ("IRB") approval by National Taiwan University Hospital and Taiwan Food and Drug Administration (TFDA).

Data from Prior Studies

Ainos has conducted one pilot study and two phase 2 trials in the U.S. involving 77 HIV-positive patients with multiple oral warts. In these trials, patients were randomized to receive either VELDONA^® or a placebo, taking the medication three times daily for 24 weeks. After treatment, patients receiving VELDONA® showed significant reductions in oral wart surface area, with decreases of over 75%, and in some cases up to 99%.

Overview of HIV

Human Immunodeficiency Virus (HIV) is the virus responsible for causing AIDS, with two main types: HIV-1 and HIV-2. HIV-1 is the dominant strain worldwide and is the primary cause of AIDS in most countries. HIV-2, found predominantly in West Africa, is less virulent and less likely to progress to AIDS.

According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), in 2023, there were approximately 39.9 million people living with HIV worldwide, with 1.3 million new infections and about 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 in August 2024.

Challenges in Treating HIV-Related Oral Warts

Currently, treatment options for HIV-related oral warts are limited, and no established pharmacological therapies exist for this condition. Only a few case reports mention the use of drugs such as cidofovir, bleomycin, cimetidine, podophyllum, or intralesional interferon-alpha injections. Surgical removal is possible but comes with the risk of recurrence.

Ainos believes that VELDONA^® has the potential to be a safe and effective treatment for oral warts in HIV-positive individuals, offering a meaningful improvement in their quality of life.

"We are excited by the data we've gathered so far and are optimistic about the potential of VELDONA^® to benefit many HIV-positive patients. Oral warts can significantly affect daily activities such as eating and speaking, as well as a person's appearance. We are hopeful that VELDONA^® will become an important option for those seeking relief from these symptoms," said Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos

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' clinical study for VELDONA (AIMD)?

Ainos' clinical study aims to evaluate the efficacy of VELDONA, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV-positive patients undergoing combination antiretroviral therapy.

When is Ainos (AIMD) expected to begin and complete the VELDONA clinical study?

The VELDONA clinical study is expected to begin in November 2024, with patient enrollment projected to take one year. The study completion is anticipated in July 2026.

What results did Ainos (AIMD) achieve in previous VELDONA trials for oral warts in HIV-positive patients?

In previous U.S. trials involving 77 HIV-positive patients, VELDONA showed significant reductions in oral wart surface area, with decreases of over 75% and up to 99% in some cases.

Has VELDONA received any special designations from the FDA for Ainos' (AIMD) oral warts treatment?

Yes, VELDONA has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of oral warts in HIV-positive patients.