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Recruitment drive for world-first viral conjunctivitis therapy

Biotech company Okogen is ramping up efforts to recruit viral conjunctivitis patients for a clinical trial, as it attempts to develop a world-first treatment for the infectious disease in Australia.

The RUBY Trial is being conducted in seven sites across the country, and will evaluate the safety and efficacy of Okogen’s lead drug candidate OKG-0301 in treating highly contagious adenoviral conjunctivitis.

To be successful, the Phase II trial needs to enroll 219 patients within the first three days of exhibiting symptoms. Principal investigators now hope to capitalise on the current flu season, and raise greater awareness among both patients and healthcare professionals.

“We are excited to see that enrollment has picked-up in the past 4-6 weeks, which may be due to the high flu season as some clinicians often find these two conditions track together,” Okogen founder and chief operating officer Mr Eric Daniels told Insight.

“Recruitment for any acute, community-acquired infectious disease can prove to be difficult as naturally patients don’t know they are going to become ill – and therefore plan accordingly. When patients do come down with an eye infection such as viral conjunctivitis, it’s important they seek treatment early.”

Daniels said the majority of patients had enrolled organically through participating trial sites, however it is hoped referrals from GPs, eyecare professionals and pharmacists will increase.

Okogen is a San Diego and Melbourne-based biotechnology company that develops ocular therapeutics. Its drug, OKG-0301, is an ophthalmic formulation of ranpirnase, the active pharmaceutical ingredient previously advanced to late stage clinical trials in oncology.

In viral conjunctivitis, of which there are no approved therapies, researchers are testing whether Okogen can reduce the length of infection as well as common signs and symptoms.

Clinical trials are now underway at Melbourne’s Royal Victorian Eye and Ear Hospital (RVEEH) in partnership with the Centre for Eye Research Australia (CERA), the Royal Adelaide Hospital, EyeClinic Albury Wodonga, Hobart Eye Clinic, Lions Eye Institute, Perth, Sydney Eye Hospital and the School of Optometry and Vision Science, UNSW, Sydney.

Associate Professor Mark Daniell, CERA principal investigator and head of the RVEEH Cornea Unit, said despite the current prevalence of viral conjunctivitis, the trial was yet to attract the number of inquires expected.

“We are hoping to get information out there that there is a chance to get involved with something that has a real potential benefit,” he said.

“The drug itself seems to be well-tolerated and safe. Certainly in the lab it kills the virus very effectively, so we are hopeful it will have an effect, because at the moment there is nothing useful. Viral conjunctivitis is a terrible condition to have, patients are very miserable, and you can easily spread it to your family and friends at work.”

More information about the RUBY Trial can be found at its website.

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