Ainos宣布瑞士制药成功生产VELDONA GMP临床批次

Subsequent Phase Involves Completion of Chemistry, Manufacturing, and Controls (CMC) Information

Ainos Intends to Submit Investigational New Drug Applications to the U.S. FDA for Multiple Candidates During the First Half of 2024

Candidates include HIV Oral Warts Orphan Drug, Sjogren's Syndrome, the Common Cold, and COVID-19

SAN DIEGO, CA / ACCESSWIRE / November 28, 2023 / Ainos, Inc. (NASDAQ:AIMD, AIMDW))))) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that its contract manufacturer, Swiss Pharmaceutical Co., Ltd. (Taiwan) ("Swiss Pharma"), has completed manufacturing of a Good Manufacturing Practice ("GMP") Clinical Batch of the Company's VELDONA® investigational new drugs.

Mr. Chun-Hsien (Eddy) Tsai, Chairman, President and CEO of Ainos, commented, "This marks another important milestone for Ainos. We have been collaborating with Swiss Pharma since August 2022 with the ultimate goal of building a high-quality, cost-effective manufacturing solution for VELDONA®. This cooperation enables Ainos to advance our key programs so that we can facilitate delivery of high-quality, safe, and effective therapeutics to individuals seeking relief from immunity issues or viral infections."

"Ainos has dedicated nearly four decades to the development of VELDONA®, accumulating a wealth of clinical data from 68 studies across 16 disease indications. Recognizing immunity as the root of many health issues, Ainos has developed VELDONA® to boost the immune response against disease and infection. Our team continues to explore these assets' latent values, including two drugs with U.S. FDA Orphan Drug Designation: oral warts in HIV-seropositive patients and Behçet's disease. We look forward to continuing our collaboration with Swiss Pharma as we advance our portfolio of VELDONA® product candidates."

Swiss Pharma has conducted testing, manufacturing, and packaging of VELDONA®'s GMP Clinical Batch for Ainos under both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice ("PIC/S GMP") and the United States Food and Drug Administration's (the "U.S. FDA") Current Good Manufacturing Practice regulations.

Following release of the GMP Clinical Batch by Swiss Pharma, Ainos intends to initiate the preparation of Chemistry, Manufacturing, and Controls ("CMC") information for submission of Investigational New Drug ("IND") applications for several programs. The Company will initially submit an IND application for conducting Phase II studies for treatment of mild COVID-19 symptoms during the first quarter of 2024. After this, Ainos intends to submit a number of additional IND applications during the first half of 2024, including Phase III studies for treatment of oral warts in HIV-seropositive patients (designated an orphan drug by the U.S. FDA), Phase III studies for Sjögren's syndrome, and Phase III studies for the common cold.

"Type I interferon (IFN) has demonstrated immunomodulating effects and an ability to interfere with viral replication, making it potentially an effective antiviral agent. Our prior studies have demonstrated that VELDONA® could inhibit respiratory virus infections, including influenza and the common cold. Patients with severe and critical COVID-19 conditions seem to be affected by an impairment in type I IFN response (no IFN-beta and low IFN-alpha production and activity). We are investigating whether impaired type I IFN could be related to persistent high blood viral loads and inflammatory responses in COVID-19 cases." stated Mr. Albert Yu, Ph.D., Ainos' VP of Drug Development.

Following promising results from preclinical studies of VELDONA® against COVID-19, Ainos is ready to initiate "A Multicenter, Randomized, Parallel, Phase II Study to Evaluate the Efficacy of VELDONA® in Patients with Mild COVID-19" in Taiwan. This study aims to evaluate the efficacy of VELDONA® in subjects presenting mild symptoms of COVID-19. Subjects will receive either a daily oral dose of VELDONA® or a standard of care (SoC) for a duration of five days, and will be evaluated throughout a 28-day study period.