COLUMBUS, Ohio--(BUSINESS WIRE)--Invirsa's first clinical trial, a Phase 1/2a study with the primary objective to determine safety and preliminary efficacy of Invirsa's topically administered eyedrop formulation of INV-102, has completed enrollment. Subjects had moderate dry eye and dosing was well tolerated in all groups.
The study's design allowed Invirsa to evaluate preliminary efficacy endpoints in 36 patients in the Phase 1 multiple ascending dose portion and 48 patients in a Phase 2 expansion cohort (both randomized 2:1 INV-102: vehicle control). Both portions were dosed for two weeks with a one-week post-treatment follow-up visit. Top line data is expected by Q3 2023.
Dr. Robert Shalwitz, CEO of Invirsa commented on the successful enrollment of the trial stating "Coupled with the strong safety and tolerability profile, the Phase 1 portion of the study hit sufficient milestones in reducing both signs and symptoms of dry eye in order to proceed to the Phase 2 portion of the study. The completion of enrollment for the Phase 2 dry eye subjects is exciting for INV-102 as a completely novel approach to treating the surface of the eye."
In addition, Invirsa recently received approval from the Thailand FDA to proceed with testing INV-102 in a second condition of acute infectious keratoconjunctivitis (AIK). Invirsa completed a thorough global review towards evaluating and selecting a study location for AIK, ultimately choosing Bangkok. The city has ideal characteristics related to high population density, historically large numbers of AIK subjects, and an excellent medical system. The Phase 2 AIK study is scheduled to begin later in Q2 of 2023 and will enroll approximately 100 subjects.
The AIK study was designed to enroll patients with either bacterial or viral infection. This is an important distinction as timely testing to identify the type of infection is unavailable and often results in the inappropriate use of antibiotics. The inappropriate use of antibiotics or corticosteroids for eye infections is a recognized concern of the American Academy of Ophthalmology.
Speaking of the AIK trial, Dr. Shalwitz stated, "There is a need for a single solution for both viral and bacterial acute infectious keratoconjunctivitis treatment to address the medical burden that is commonly known as pink eye. Invirsa’s Phase 2 AIK trial will test INV-102, compared to vehicle control, in reducing clinical signs and symptoms after only one week of treatment regardless of whether the presenting AIK is viral or bacterial.”
Commenting on the strong clinical research organization partnerships for both trials, Dr. Charlotte Hartman, VP of Clinical Development at Invirsa added "Our team has been fortunate to work with Iuvo on the Dry Eye Study here in the USA and Grand Pacific CRO on the AIK trial in Thailand. We are pleased to be working with both organizations as they have added tremendous expertise in order to quickly complete one study and to shortly launch another."
Invirsa's projects have been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50120C00171.
Invirsa's INV-102 is a small molecule that has been shown in vitro to activate 2 major pathways: The first being the protein p53, which is known as “the guardian of the genome”, and the second being Pax6 which is critical for cellular stability particularly in the eye. By activating these 2 pathways, INV-102 achieves accelerated DNA repair and enhanced cellular stabilization.