AyuVis
Suchismita Acharya
AyuVis has been awarded a $2.1 million National Institute of Health research grant from the National Heart, Lung, and Blood Institute that will 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.
“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,” said Suchismita Acharya, co-founder and CEO of AyuVis, in a statement. “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.”
It is the fourth NIH grant AyuVis has received since its founding, doubling total nondilutive funding to $4.2 million, the company said. 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 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 other 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, according to a press release.
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).
“There is a critical unmet need for a safe, effective, and affordable drug for acute and chronic inflammatory and infectious diseases,” Acharya said. “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.”
Acharya, the principal investigator leading the grant, 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.
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, Senior Operations Manager.