Invirsa submits FDA INV-102 IND application


The company has filed an ophthalmic IND submission for the first treatment of ocular conditions associated with DNA damage.

Invirsa this week announced that it has submitted to the FDA an investigational new drug (IND) application for its lead compound, INV-102 for the treatment of ocular conditions associated with DNA damage.

According to a news release, Invirsa is planning to conduct INV-102’s first human clinical study in subjects with dry eye.

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.

Robert Shalwitz, MD, CEO and co-founder of Invirsa, noted in the news release that 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,” he said in the news release. “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.

Shalwitz noted in the release that a compound that accelerates DNA repair could potentially be a great discovery for therapeutics.

“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,” he said in the news release. “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.

According to the news release, the 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.

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