Okogen Announces Interim Analysis Results From RUBY Phase 2 Trial for Acute Adenoviral Conjunctivitis Drug Candidate

Okogen 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 4 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 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.