Invirsa Inc. announced it has raised $7.7 billion Series B financing to support its lead therapeutic candidate.
Give me a refresh on the company.
Launched in 2015, Invirsa is a privately-held, clinical-stage pharmaceutical company based in Columbus, Ohio, and focused on the development of a therapeutic treatment for ocular diseases associated with DNA damage (but more on that later).
Let’s talk financing.
Completed in April 2023, the company’s investment round was led by Cincy-Tech, an Ohio-based venture firm with a 30+ company portfolio of founders and researchers in Southwest Ohio who are advancing novel science, technology, and insights that could potentially change or create larger markets.
Supporting companies included Rev1 Ventures, JobsOhio Growth Capital Fund, and JumpStart Ventures.
How will it be used?
According to Invirsa, the company plans to use the funding to advance INV-102, its lead product candidate, through a series of phase 2 studies—centered on conditions such as dry eye disease (DED), acute infectious keratoconjunctivitis, and Fuch’s endothelial corneal dystrophy (FECD)—as well as phase 3 preparations.
Gotcha. Now tell me about IN-102.
INV-102 is an topical ophthalmic formulation currently in clinical studies for respiratory and dermatological conditions, as well as ocular conditions derived from a naturally-occurring small molecule that directs pathway activities crucial to both the DNA damage repair response (p53) and cell stability (PAX6).
Go on …
The therapeutic provides a short-term activation of p53, a protein that guides damaged cells by slowing the cell cycle giving them time to repair their DNA.
However, p53 can potentially determine a cell to be unrepairable, and, as a result, cause apoptosis to occur.
So how is this prevented?
That’s where INV-102 comes into play.
According to Invirsa, the therapeutic generates a predictable and rhythmic increase in p53, which then potentially enables DNA repair to occur—sans cell death.
But how is inflammation prevented?
Glad you asked!
But first, note that p53 and nuclear factor kappa B (NF-κB) have an antagonistic relationship.
So when cell damage causes an increase in the production of NF-κB—another protein—and leads to inflammation, INV-102 might limit inflammation at the injury location (and, as a result, possibly improves cell stability).
Is there any clinical data on INV-102 yet?
According to the company, INV-102 has previously demonstrated unprecedented efficacy in animal models of sulfur mustard-induced ocular injury—and is the first drug with the potential to prevent long-term effects.
Additionally, Invirsa announced in May 2023 that patient enrollment has completed for its phase 1/2a first-in-human (FIH) trial (NCT05586152) on INV-102 for DED.
See here for more details on the study.
What’s next?
Topline data from the phase 1/2a study is expected in Q3 2023.
Per Invirsa, a phase 2 clinical development program for acute infectious keratoconjunctivitis is expected to launch in Q3 2023.
Other planned studies include:
Phase 2 pilot study → FECD (Q4 2023)
Additional study → DED (Q1 2024)