COLUMBUS, OH., August 25, 2022 - Invirsa today announced that it has submitted to the US Food and Drug Administration (FDA) an investigational new drug (IND) application for its lead compound, INV-102 for the treatment of ocular conditions associated with DNA damage. Invirsa is planning to conduct INV-102’s first human clinical study in subjects with dry eye starting in late August 2022.
Ocular DNA damage occurs daily, and can be caused by various factors, such as ultraviolet (UV) radiation and other environmental stresses. In addition, damage may be caused by infectious agents, chemicals including sulfur mustard, and other factors.
Dr. Robert Shalwitz, CEO and co-founder of Invirsa expanded, saying “DNA damage is always happening in the cells of our body at levels that the body can usually repair. However, with aging and excessive cellular stress, the rate of DNA damage can exceed our cells’ ability to achieve a complete repair. This can lead to persistent cellular dysfunction and poor healing of the tissue.”
A growing chorus of research shows a strong relationship between high levels of DNA damage and corresponding tissue inflammation and dysfunction. Invirsa’s technical breakthrough was the development of a modified naturally occurring compound that activates the master regulator of the DNA damage response, the p53 protein. In preclinical studies, INV-102 showed potent healing activity with an excellent safety profile across a wide-variety of severe conditions associated with DNA damage.
“A compound that accelerates DNA repair is potentially a great discovery for therapeutics,” Dr. Shalwitz said. “Following the acceptance of our IND application, we are looking forward to beginning INV-102’s first human clinical trial in dry eye to demonstrate clinical safety and initial clinical efficacy. This will clear the way for future investigational use of INV-102 as a therapeutic for various ocular conditions through the unique mechanism of enhanced DNA repair.”
Safety and efficacy results are expected in the first quarter of 2023.
This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00171.
Invirsa, founded in 2015, is a biotech company that has received private and public funding. To date, Invirsa has been awarded a $17 million contract, with options for another $13 million based on milestones, from the Biomedical Advanced Research and Development Authority (BARDA), a division of Administration for Strategic Preparedness and Response within the US Department of Health and Human Services. Invirsa has also received venture capital investment from CincyTech, Rev1 Ventures and the Ohio Innovation Fund.
Method of Research
Randomized controlled/clinical trial
Subject of Research