AyuVis Awarded $1.8M Grant to Support Pediatric Drug Development Program

AyuVis has received an official Notice of Award for a $1.8M National Institute of Health (NIH) Small Business Innovation Research (SBIR) grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

It is the third NIH/SBIR grant AyuVis has received since its founding, bringing total non-dilutive funding to $2.1M. The NICHD is one of the institutes of the NIH in the U.S. Department of Health and Human Services.

The grant will fund the continuation of AyuVis’ development of new immunotherapies to dually treat inflammation and infection; it advances preclinical research for AyuVis’ first target indication, bronchopulmonary dysplasia (BPD), which will enable Phase 2 clinical trials. BPD is the second leading cause of death in premature babies, induced by supplemental oxygen administered in the NICU that is needed for survival, but also leads to lung inflammation and tissue damage.

“HSC is excited about this achievement for AyuVis” said Robert McClain, PhD, the Associate Vice President of Research & Innovation at the University of North Texas Health Science Center at Fort Worth. “The SBIR program is a powerful catalyst for innovation, but underutilized in Tarrant County. AyuVis is an outstanding example to other startups in the region of how to leverage this non-dilutive funding source.”

The Principal Investigator (PI) leading the grant will be Dr. Suchismita Acharya, the Founder and CEO of AyuVis. Dr. Acharya is a pharmaceutical scientist with more than 15 years of experience in drug discovery and development with large and small pharmaceutical companies, including Alcon Labs and Novartis.

When Dr. Acharya began the drug discovery process for AyuVis’ pipeline of immunotherapies, she had three properties in mind for ideal drug candidates. She searched for and designed molecules to make them easy to manufacture, easy to formulate and to be safe with no toxicity – all of which were confirmed in preclinical studies. AyuVis has completed all the necessary preclinical studies to prepare an Investigation New Drug (IND) application for its lead drug candidate, AVR-48.

“This is a very exciting time for AyuVis. Getting a Direct to Phase-II SBIR grant from the NICHD speaks volumes of our excellent team, sound science and well-thought-out commercialization strategy,” Dr. Acharya said.

“This grant funding will enable us to complete the last portion of non-clinical, large animal pharmacological studies and push the lead compound, AVR-48, to the clinic faster. Additionally, this grant opens opportunities for subsequent follow-up, non-dilutive funding from the NIH and other agencies. The timing is perfect.”

This new generation of immunotherapies is based on a platform technology of macrophage modulation to balance the immune system’s response to inflammation and infection simultaneously. Because the anti-microbial activity is through the increase of phagocytosis, (which is 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. This is based on strong preclinical data that shows AyuVis’ therapies are effective synergistically with existing antibiotics in sepsis and pneumonia models.

“AyuVis’ AVR-48 shows promising efficacy in small and large animal models of BPD, and safety in IND-enabling toxicology,” said Dr. Stella Robertson, a Cowtown Angels investor and AyuVis Board member. “I am pleased to serve as a development advisor for the grant.  The Cowtown Angels, which provided the first angel seed funding for AyuVis, is proud of the progress Dr. Acharya and her team have made. This will be a big step toward developing a therapy to improve the lives of preterm babies.”

AyuVis selected BPD as its first target indication because it is an area of high unmet medical need with no FDA-approved therapies for prevention or treatment. BPD has a 9% mortality rate and those who do survive often require ongoing care. AyuVis’ first goal is to save and improve the lives of these babies by preventing BPD in at-risk preterm infants with its unique, first-in-class immunotherapy.

AVR-48 is Orphan Drug and Rare Pediatric Disease Designated for the prevention of BPD. AVR-48 is in near-clinical stage and approaching the start of a first-in-human Phase 1 clinical trial, to be completed in parallel with the remaining BPD efficacy studies that this grant will fund.

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; and a partner with the University of North Texas Health Science Center at Fort Worth in its HSC Next Innovation Labs incubator program.

The AyuVis team members are: David Riley, MD, MBA, Chief Medical Officer; Dale Christensen, PhD, Director of Early Development; Stella Robertson, PhD, Drug Development Advisor; William Dean, PhD, Head of CMC; Russell Bromley, Director of Operations; Ranjan Misra, Business Advisor; and Darlene Boudreaux, MBA, CPA, former Executive Director of TechFW, as CFO.

To learn more about AyuVis’ innovative immunotherapies, please visit www.ayuvis.com