FORT WORTH, TX – AyuVis has received an official Notice of Award for a National Institute of Health (NIH) research grant from the National Heart, Lung, and Blood Institute (NHLBI) that will total $2.1M to fund preparations and the initiation of a first-in-human Phase 1 clinical trial.
AyuVis is developing a new generation of immunotherapies, including AVR-48, that, rather than simply activating or suppressing the immune response, provides a well-balanced outcome where mild activation and controlled suppression of the immune system is needed to effectively treat disease. This process allows the drug to control inflammation and infection.
It is the fourth NIH grant AyuVis has received since its founding, doubling total non-dilutive funding to $4.2M. The NHLBI is the third largest institute of the NIH in the U.S. Department of Health and Human Services.
This grant will support preparations and advancement of AyuVis to a clinical-stage pharmaceutical company. This First-in-Human Phase 1 Clinical Trial in Healthy Adult Volunteers will assess the safety of the new anti-inflammatory and anti-infective small molecule immunotherapy, AVR-48, and enable Phase 2 clinical trials for multiple of AyuVis’ development programs. An Investigational New Drug (IND) application is in preparation to be submitted to the U.S. Food and Drug Administration during 2023 for this Phase 1.
AyuVis’ first target indication is the prevention of bronchopulmonary dysplasia (BPD), a chronic lung disease in preterm babies where there are no available FDA-approved therapies. Follow-on indications with high unmet medical need that will progress with this Phase 1 include the treatment of acute respiratory distress syndrome (ARDS) and ventilator-associated pneumonia (VAP).
“I am extremely thankful to NHLBI for this clinical trial grant award and excited that we are moving our lead compound into a human trial. This is a huge milestone for AyuVis, and we are one step closer to making a significant difference in saving lives, which was my passion and vision when I started the company nine years ago, said Dr. Suchismita Acharya, co-Founder and CEO of AyuVis.
“There is a critical unmet need for a safe, effective, and affordable drug for acute and chronic inflammatory and infectious diseases. We have assembled an excellent clinical team and clinical research organization. Together we look forward to moving our first compound in the pipeline to the clinic while continuing research on additional drug candidates.”
White blood cells are the body’s first line of defense against inflammation and infection. AyuVis’ immunotherapy is based on a platform technology of modulating circulating macrophages (white blood cells) to rapidly balance the immune system’s response to inflammation and infection simultaneously. Because the anti-microbial activity is through the increase of phagocytosis -- when white blood cells surround and destroy foreign substances, such as bacteria, and remove dead cells -- it is expected that AyuVis’ therapies will circumvent multi-drug resistance. AVR-48 also has shown in large animal studies to promote new lung cell growth and prevent tissue injury that could be caused by hyper-inflammation.
Dr. Acharya will be the Principal Investigator (PI) leading the grant. She has more than 25 years of experience as a pharmaceutical scientist in drug discovery and development with large and small pharmaceutical companies, including Alcon Labs and Novartis, where she led drug development projects and commercialized products. Dr. Acharya has been highly successful in securing multiple grant fundings from the NIH in the past five years to progress projects from early pre-clinical animal research to human clinical trials.
AyuVis is a member company of TechFW, a nonprofit technology business incubator and accelerator in Fort Worth; a portfolio company of the Cowtown Angels, an angel investor network affiliated with TechFW; a partner in the University of North Texas HSC Next Innovation Labs; and a participant in the Small Business Innovation Research (SBIR) Phase 0 grant writing program at HSC Next.
The AyuVis core team members are: David Riley, MD, MBA, Chief Medical Officer; Mariam Morris, MS, CPA, CFO; Dale Christensen, PhD, Director of Early Development; Stella Robertson, PhD, Drug Development Advisor; William Dean, PhD, Head of Chemistry, Manufacturing and Controls (CMC); Russell Bromley, Director of Operations; Ranjan Misra, Business Advisor; and Sarah Wright, Sr. Operations Manager.
To learn more about AyuVis’ innovative immunotherapies, please visit www.ayuvis.com or send an email inquiry to:
Sr. Operations Manager