Keratoconjunctivitis, Infectious

COLUMBUS, Ohio--(BUSINESS WIRE)-- Invirsa Inc., a privately held, clinical-stage pharmaceutical company focused on developing an innovative topically administered eyedrop formulation INV-102 for ocular conditions associated with DNA damage, announced the closing of a $7.7 million Series B financing completed in April earlier this year. The financing was led by Ohio-based venture firm, CincyTech, with participation from Rev1 Ventures, JobsOhio Growth Capital Fund, and JumpStart Ventures. The financing advances Invirsa's lead product candidate, INV-102, for treatment of conditions associated with DNA damage. Funds will support a series of Phase 2 studies in conditions including acute infectious keratoconjunctivitis, dry eye disease, and Fuchs corneal dystrophy. In addition, funds will support Phase 3 preparation. “The recent Series B funding is a significant milestone for Invirsa, which allows us to advance the clinical development of INV-102, a topical eye drop that has completed initial testing in dry eye patients (Phases 1 and 2a). Dry eye continues to be an important market with a significant unmet medical need," said Dr. Robert Shalwitz, Chief Executive Officer of Invirsa. “The recent investment led, by CincyTech with other Ohio life science investment funds, provides strong validation of our vision and approach." CincyTech's Life Sciences Partner, John Rice, added, "There are an estimated 7 to 8 million people in the US alone with dry eye who lack a suitable therapeutic for their condition. As a result, there is a significant need for new, well-tolerated treatment options. We look forward to continuing working with Invirsa's management team to advance INV-102's clinical development for dry eye and other ocular conditions.” About Invirsa Leading Invirsa is an accomplished team of drug developers with key ophthalmology industry advisors to develop an innovative eye drop to reduce signs and symptoms of dry eye and other ocular surface conditions associated with DNA damage. The Phase 2 clinical development program for INV-102 includes a study in acute infectious keratoconjunctivitis (pink eye) in Q3 2023, a Phase 2 pilot study to evaluate the reduction of edema in subjects with Fuchs Endothelial Corneal Dystrophy (FECD) in Q4 2023, and an additional study in patients with dry eye disease (Q1 2024). Invirsa's projects have 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. About INV-102 Invirsa's lead therapeutic, INV-102, is a new treatment for ocular conditions that is derived from a naturally occurring small molecule which modulates the activity of pathways critical to the DNA damage repair response and cellular stability. The first pathway is the protein p53, known as "the guardian of the genome," and the second is Pax6 which is critical for cellular stability, particularly in the eye. In vitro tests have shown that INV-102 reduces cellular injury/death caused by adenovirus (the primary virus associated with infectious conjunctivitis) and other causes of DNA damage. In vivo studies have demonstrated superior efficacy in several animal models. Learn more at: About CincyTech CincyTech is a Cincinnati-based venture firm focused on seeding and scaling a new generation of transformational Midwest companies. CincyTech invests in founders and researchers advancing novel science, technology, or insight that change or create large markets. Since 2007 CincyTech funds have invested in almost 90 seed-stage high-growth opportunities and support an active portfolio of more than 30 companies. Learn more at: View source version on businesswire.com: Contacts Frank Scardena, Sr. Director, Marketing Tel: 614.787.7372 fscardena@invirsa.com Source: CincyTech View this news release online at:

Invirsa has also received approval from the FDA equivalent authority in Thailand to proceed with Phase 2 Acute Infectious Keratoconjunctivitis clinical trial in Bangkok 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." About Invirsa: 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. About INV-102 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.

WEST HAVEN, Conn.--(BUSINESS WIRE)--NanoViricides, Inc. (OTC BB: NNVC.OB) (the “Company”) reported today that excellent efficacy of its EKC-Cide™ nanoviricide drug candidate was revealed upon statistical analyses of clinical scores from the first animal study. The EKC-Cide drug candidate clearly demonstrated prevention of conjunctival injection (redness, dilation and prominence of the conjunctival blood vessels) and blepharitis (crusting, discharge and inflammation of the eyelid margins) using mathematical clinical scores calculations. These data confirmed the excellent clinical response observed earlier in eye photographs. In contrast, the control group which received an inactive drop preparation (“negative control”) displayed statistically significant higher clinical scores consistent with the expected strong progression of infection. A rapid clinical response to the EKC-Cide treatment was also revealed by these data, confirming earlier photograph observations. Substantial differences in clinical scores, demonstrating clear prevention of serious infection and improvement upon treatment, were observed within three days after treatment. Moreover, while both scored parameters (conjunctivitis and blepharitis) were still significantly elevated even at day 10 in the “negative control” group; in the EKC-Cide treated group both parameters had returned to normal already at day 7, indicating full recovery. These clinical scores were based on daily observations and recording of the animals by trained observers. Further biological analyses are in progress. “These results confirm our earlier preliminary photographic evidence,” said Eugene Seymour, MD, MPH, CEO of the Company, adding, “We now know that EKC-Cide efficacy is substantially superior to that of other drugs in development against EKC.” The Company has previously posted photos on its website which demonstrated the rapid response to treatment using the Company’s nanoviricide drug candidate against Epidemic Kerato-Conjunctivitis (EKC) ( ). “EKC-Cide may have efficacy against other viral conjunctivitis as well,” said Anil R. Diwan, Ph.D., President of the Company, “It uses a broad-spectrum ligand for finding the virus. Binding sites for this ligand may be present on a large number of viruses.” The Company plans to evaluate this broad-spectrum eye-drop formulation against other viruses that cause eye diseases such as herpes simplex virus (HSV). The Company has previously reported that it is in talks with certain pharmaceutical companies regarding potential licensing of a nanoviricide against adenoviral EKC. The two clinical scores employed were for “conjunctival injection” i.e. redness and dilation or prominence of conjunctival blood vessels, and for “blepharitis” i.e. crusting, discharge and inflammation of eyelid margins. Both are classic signs of pathological infection. While the Company currently has no approved product for the treatment of EKC and viral conjunctivitis, the treatment and prophylaxis market for these classes of eye disease is expected to be of the order of several billion dollars annually. EKC is a highly contagious and very severe inflammation of the eyes that results in disabling red eyes, discharge and inflammation of the eyelids with clinical symptoms lasting several weeks. Bacterial conjunctivitis may be treated with antibiotics; however, there is no treatment currently available for viral EKC. Further, viral EKC, in some cases, may result in the formation of hazy spots in the cornea called “sub-epithelial infiltrates” which cause blurriness of vision, a condition that may last up to two years. About NanoViricides: NanoViricides, Inc. ( ) is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel nanoviricide™ class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H5N1 bird flu, seasonal influenza, HIV, EKC, hepatitis C, rabies, dengue fever, and Ebola virus, among others. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements of the company to be different from those expressed or implied including the success of the Company's research and development efforts, the availability of adequate financing, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process, described in the “Management’s Discussion and Analysis” section of the Company’s Form 10-KSB and other reports and filings with the Securities and Exchange Commission. Contact: NanoViricides, Inc. Amanda Schuon, 310-550-7200 info@nanoviricides.com Source: NanoViricides, Inc.