BARDA is partnering with Invirsa to develop the company’s investigational product INV-102 to treat ocular conditions associated with DNA damage to include sulfur mustard injury. By funding this advanced research and development effort, the product will progress toward potential Food and Drug Administration (FDA) approval.
Sulfur mustard is a type of chemical warfare agent that causes blistering of the skin and mucous membranes on contact. Sulfur mustard is a powerful irritant that damages the skin, eyes and respiratory tract. Toxicity is thought to be caused primarily by DNA damage. In the eye, initial signs and symptoms of sulfur mustard exposure include irritation, pain, swelling and tearing that occur within three to twelve hours after exposure. However, delayed effects can include corneal opacification and permanent blinding.
Acute infectious conjunctivitis, a common eye condition, also causes DNA damage. Treatment for this condition is a large unmet need, and an effective treatment for DNA damage could have a significant, positive impact in this field of medicine.
There are currently no FDA-approved drugs to treat sulfur mustard ocular injury. Advanced research and development to include nonclinical IND-enabling studies and clinical trials to demonstrate safety and efficacy of candidate therapeutics are needed to fill this unmet need.
INV-102 is derived from a naturally occurring small molecule that modulates the activity of p53, the central protein that regulates the DNA damage response. As an eye drop, INV-102 has the potential to treat the delayed, long-term eye injury and blindness observed after sulfur mustard exposure. If approved, INV-102 would be the first clinically effective treatment for sulfur mustard ocular injury. Additionally, the broad indication would open the market potential for the drug, thereby increasing community availability and sustainability, two key requirements in rapid response to a chemical incident.
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Invirsa is an Ohio pharmaceutical company with a lead compound that provides damage control at the DNA level. By quickly and predictably augmenting the body’s response to DNA damage, INV-102 improves cell stability at the critical moment. Invirsa plans to enter clinical trials in the near future for indications related to the eye, acute infectious keratoconjunctivitis and keratoconjunctivitis sicca. In addition, Invirsa intends to expand its platform into other conditions associated with DNA damage such as herpes keratitis and viral pneumonia.