Ainos Seeks FDA Nod For Mid-Stage Covid-19 Study

Ainos, Inc. AIMD has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for conducting a Phase 2 trial of its drug candidate VELDONA, for treatment of mild symptoms related to COVID-19.

The company has developed its low-dose oral IFN-alpha formulation VELDONA® to boost the human immune response against disease and infection.

The Phase 2 trial is expected to involve a multicenter and parallel study conducted in Taiwan to evaluate the efficacy of VELDONA in subjects with mild symptoms related to COVID-19.

The enrolled subjects will receive either a daily oral dose of VELDONA or a standard of care (SoC) for 5 days and will be evaluated throughout a 28-day study period.

Chun-Hsien Tsai, Chairman of the Board, President and CEO, commented : "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). Our Company is investigating whether impaired type I IFN could be related to persistent high blood viral loads and inflammatory responses in COVID-19 cases."

The company noted, the previous studies have demonstrated that VELDONA could inhibit respiratory virus infection, including influenza A.

Price Action : Ainos shares are trading around 1 percent down at $2.43 on Wednesday during pre-market session.