AyuVis Research Receives FDA Clearance for AVR-48 to Proceed with a Phase 1 Clinical Study
January 23rd, 2024
FORT WORTH, TX. – AyuVis Research, Inc., a clinical-stage biopharmaceutical company developing a new generation of immunotherapies to address inflammation and infection, has received U.S. Food and Drug Administration ("FDA") acceptance for its AVR-48 Investigational New Drug (IND) application and will proceed with a Phase 1 clinical trial.
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.
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.
The FDA notified AyuVis it could proceed with a "Study May Proceed" letter for a Phase 1, DoubleBlinded, Placebo-Controlled Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to evaluate the safety and tolerability of AVR-48 in healthy adult volunteers.
The study is expected to begin in 2024 and will be partially funded by an ongoing National Heart, Lung and Blood Institute Research Grant awarded in 2023.
Dr. David Riley, Chief Medical Officer and practicing neonatologist, said: “This is a tremendous milestone. The IND provides AyuVis with scientific validation from a major regulatory body for the pre-clinical safety and efficacy of our lead compound, AVR-48. We look forward to demonstrating the utility of AVR-48 in upcoming clinical trials on our path to regulatory approval."
The Phase 1 clinical trial 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.
“I am very excited about the IND approval to begin the clinical trial and very thankful to our pre-clinical, clinical, CMC and regulatory team’s efforts to make this happen. This is a major milestone achievement for AyuVis’ small molecule immunotherapy platform program,” said Dr. Suchi Acharya, co-founder and CEO of AyuVis.
About AyuVis Research, Inc.
AyuVis’ first target indication is the prevention of bronchopulmonary dysplasia (BPD), a rare pediatric and orphan disease with chronic lung injury in preterm babies where there are no available FDAapproved therapies. Follow-on indications with high unmet medical need include the treatment of acute respiratory distress syndrome (ARDS) and ventilator-associated pneumonia (VAP), along with the use as a novel vaccine adjuvant for several infectious diseases. AyuVis is a multi-asset, multi-indication pharmaceutical company.
AyuVis is a member company of Blue Knight accelerator, a collaboration between Johnson & Johnson Innovation – JLABS and the Biomedical Advanced Research and Development Authority (BARDA); a member company of TechFW, a nonprofit technology business incubator and accelerator in Fort Worth; and a partner in the University of North Texas Health Science Center HSCNext Innovation Labs.
To learn more about AyuVis’ innovative immunotherapies, please visit www.ayuvis.com or send an email inquiry to:
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