Suchi Acharya
AyuVis Research, Inc., a clinical-stage biopharmaceutical company developing a new generation of immunotherapies to address inflammation and infection, has received approval from the U.S. Food and Drug Administration to begin human clinical trials on its lead compound, AVR-48.
AyuVis is developing a new generation of immunotherapies that provide a well-balanced immune response where mild activation and controlled suppression of the immune system is needed to effectively treat disease.
The go-ahead is “provides AyuVis with scientific validation from a major regulatory body for the pre-clinical safety and efficacy of our lead compound, AVR-48,” said David Riley, AyuVis chief medical officer, in a statement.
“We look forward to demonstrating the utility of AVR-48 in upcoming clinical trials on our path to regulatory approval,” he said.
AVR-48 is the lead drug candidate from a series of novel compounds derived from chitohexaose. As seen in pre-clinical research, AVR-48 has the power to:
- Prevent inflammation and tissue damage;
- Promote new lung cell growth;
- Quiet the cytokine storm when the immune system produces too many inflammatory signals, which leads to organ failure and death;
- Remain effective against multi-drug resistant infections.
This is the next step in AyuVis’ initial goal of preventing a rare pediatric disease, bronchopulmonary dysplasia, and will be the foundation that supports follow-on respiratory programs in the pipeline.
AyuVis is a client of TechFW, the nonprofit incubator that assists the growth of tech companies. AyuVis conducts its research at The University of North Texas Health Science Center in Fort Worth.
The Phase 1 clinical trial to evaluate the safety and tolerability of AVR-48 in healthy adult volunteers is expected to begin in 2024 and will be partially funded by an ongoing National Heart, Lung and Blood Institute Research Grant awarded last year.
“I am very excited about the IND [Investigational New Drug] approval to begin the clinical trial and very thankful to our pre-clinical, clinical, CMC and regulatory team’s efforts to make this happen,” said Dr. Suchi Acharya, co-founder and CEO of AyuVis. “This is a major milestone achievement for AyuVis’ small molecule immunotherapy platform program.”