San Diego, CA and Melbourne, AUS – April 29, 2021 – Okogen, a clinical-stage specialty ophthalmic biotechnology company announced the interim analysis results from RUBY, the company’s Phase 2, double-masked, placebo-controlled clinical trial evaluating the safety and efficacy of OKG-0301 in patients with acute adenoviral conjunctivitis. In 58 patients diagnosed with acute adenoviral conjunctivitis, OKG-0301 was safe and demonstrated an effective, dose-dependent anti-viral response. This data will be presented by Professor Stephanie Watson (Principal Investigator of the RUBY Trial) in greater detail at the ARVO virtual annual meeting, May 1-7, 2021.
Subjects enrolled in RUBY received either one of two doses of OKG-0301 or a vehicle control and self-administered the topical eye drop four times per day over a 5-day period. The investigational drug was well tolerated, with no reported ocular related adverse events suspected due to the drug. OKG-0301 demonstrated a statistically significant antiviral effect via reduction of viral titers (as measured by PCR) relative to placebo at Day 7. In evaluating viral eradication (CC-IFA), a clear dose dependent response was observed.
“OKG-0301 performed in the clinic exactly how it has worked in the laboratory. In our patients, the drug clearly knocked down virus relative to placebo and this is the foundation to any antiviral drug,” said Professor Watson, adding “by co-formulating OKG-0301 with a safe and well understood ocular decongestant, we have line of sight to the development of the first drug available to treat this highly infectious condition.”
Building off this data, the company has put forth its planned clinical development steps to the US FDA, outlining a phase 3 program to begin in 2022. According to Dr. Brian Strem, CEO of Okogen, “treating adenoviral conjunctivitis remains an unmet need in the arsenal of ophthalmic anti-infectives and we are committed to addressing a highly infectious condition that impacts individuals, families, schools, and workplaces.”
Following the presentation at ARVO, the company’s data will be made available at www.okogen.com.
About Okogen
Okogen is a clinical-stage, specialty biotechnology company focused on developing therapeutics to help patients with ocular diseases. The company’s lead development candidate, OKG-0502, is a fixed dose combination of a broad-spectrum antiviral (OKG-0301) that functions intracellularly to inhibit viral replication and an ocular decongestant that addresses the associated signs and symptoms of adenoviral conjunctivitis. These mechanisms of action are further expected to provide clinical benefit in addressing adenoviral infections of the eye as well as other classes of viruses that are active in the ocular space, including herpes simplex virus, varicella-zoster virus, and more.
For more information about Okogen, visit www.okogen.com. To learn more about the RUBY trial, visit www.rubytrial.com.au or clinicaltrials.gov (NCT03856645).
