Invirsa has completed patient enrollment for its phase 1/2a study on INV-102, an eye drop formulation, for the treatment of dry eye disease (DED).
Tell me about Invirsa.
Launched in 2015, the Columbus, Ohio-based pharmaceutical company is focused on developing a molecule (INV-102) that promotes ocular DNA repair and the innate immune response to infection and injury.
Now INV-102
Administered as an ophthalmic eye drop, Invirsa’s lead candidate is a naturally-occurring, small molecule that modulates the activity of p53, the central protein responsible for regulating the DNA damage response.
INV-102 is currently in development for DED, acute keratoconjunctivitis, and upper respiratory tract infections.
Give me a timeline.
In 2020, Invirsa received a $29.6 million award from the Biomedical Advanced Research and Development Authority (BARDA) to support clinical development of INV-102 for the treatment of sulfur mustard-induced ocular injury and other DNA damage-associated ocular injuries (through phase 3 clinical trials).
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.
In August 2022, Invirsa submitted an investigational new drug (IND) application for INV-102.
Now talk about the study.
The multicenter, randomized, double-masked, vehicle-controlled, first-in-human, phase 1/2a study (NCT05586152) is assessing the INV-102 as a topically administered eye drop during repeat dosing throughout a 2-week period in 84 patients (≥18 years of age) diagnosed with moderate symptomatic DED in at least one eye.
The trial is split into two parts:
- Phase 1: A dose-escalation phase of four patient cohorts (36 patients) to determine INV-102’s safety and tolerability.
- Phase 2: An optional dose-expansion phase with a fifth patient cohort (dependent on phase 1 outcomes; includes 48 patients) to determine INV-102’s efficacy for DED.
Both phases include a 1-week post-treatment follow-up visit.
And the dosing levels?
Phase 1’s cohorts include the following INV-102 dosages throughout a 2-week period:
- Cohort 1→ 0.1% (twice daily)
- Cohort 2→ 0.25% (twice daily)
- Cohort 3→ 0.7% (twice daily)
- Cohort 4→ 0.7% (thrice daily)
Phase 2’s cohort 5 included INV-102 administered for 2 weeks using a dosage based on the resulting data from phase 1’s cohorts 1-4.
How about the placebo?
For all five cohorts in phase 1 and 2, the vehicle was administered either two or three times a day—depending on the cohort and dosing frequency—for 2 weeks.
What are the primary outcomes of the study?
For phase 1, the incidence of treatment-emergent adverse events (TEAEs); for phase 2, the efficacy of either the Eye Dryness Score or Eye Discomfort Score (dependent on phase 1 results).
Any feedback on phase 1 yet?
The company reported that the dosing of patients was well-tolerated in all groups.
According to Invirsa CEO Robert Shalwitz, MD, the first part of the study met sufficient milestones in minimizing dry eye signs and symptoms—enabling the study to proceed to phase 2.
When can we expect results?
Invirsa plans to release topline data in the third quarter of 2023.