Australian Phase II trial commences for potential world-first treatment of viral conjunctivitis
January 31, 2019
Okogen, a biotech company developing ophthalmic therapeutics, today announces the launch of Phase II trials which will see its lead therapy trialled on patients with conjunctivitis across Australia.
The Phase II clinical trial (RUBY) will evaluate the safety and efficacy of Okogen’s lead candidate, OKG-0301, in the treatment of acute adenoviral conjunctivitis (commonly known as viral conjunctivitis). The trials will take place at seven clinical sites in Sydney, Melbourne, Albury, Adelaide, Perth and Hobart.
Adenoviral conjunctivitis is a highly contagious disease that affects up to 25 million people worldwide each year, making it the number one cause of eye infections globally.
Bacterial conjunctivitis is typically treated with antibiotics including eye drops or ointments, however these do not work in treating viral forms of the infection. Despite the high incidence of viral conjunctivitis, there are no approved therapies for the disease, and care is mainly supportive.
The infection can persist for up to three weeks, and patients are highly contagious for 10-14 days. This puts families and communities, including schools and daycare centers, at risk for rapid spread of the infection and persistence of the virus within the population.
“Antibiotics are not the answer to viral conjunctivitis. Their use has the potential to lead to future infections with multi-drug resistance, and delays proper eye care which can lead to longer-term and more significant negative outcomes on eye health,” said Brian M. Strem, Chief Executive Officer at Okogen.
“These trials in Australia are hugely important for the development of the world’s first effective treatment for conjunctivitis. To be eligible for our trials, candidates must commence treatment with us within three days of first reporting a presence of viral conjunctivitis symptoms – so if you are experiencing symptoms now please see your GP or contact us directly about joining our trial.”
The RUBY trial, a phase II, multi-site, randomized, placebo-controlled, double-blinded clinical trial, will evaluate multiple doses of OKG-0301 in 219 adult patients with acute adenoviral conjunctivitis. Patients affected by adenoviral conjunctivitis suffer eye redness with swelling and ocular discharge, accompanied by symptoms including pain, itching, and foreign body sensation.
Professor Stephanie Watson of Save Sight Institute and The University of Sydney is the principle investigator coordinating the trials which will take place across Australia. Trial sites include: Save Sight Institute, Sydney Eye Hospital, Sydney; Lions Eye Institute, Perth; Royal Adelaide Hospital, Adelaide; Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne; Hobart Eye Clinic, Hobart; Albury Eye Clinic, Albury; University of New South Wales, Sydney.
Professor Watson commented: “I have been impressed with the consistent results of OKG-0301 in laboratory models of adenoviral conjunctivitis. My fellow investigators and I are excited to have the opportunity to evaluate how this novel antiviral therapy may be able to help patients suffering from this very common condition.”
In addition to testing efficacy, investigators will assess OKG-0301’s safety and potential to diminish longer-term complications of adenoviral infection that negatively affect vision and lead to scarring of the ocular surface.
In December 2017, the clinical-stage company, announced an AU$13 million investment in Series A Funding from Brandon Capital’s Medical Research Commercialisation Fund (MRCF) to advance its development of OKG-0301.
The New South Wales Department of Health and Medical Research has been integral in bringing the Okogen clinical trials to the state of New South Wales.
To take part in the RUBY trial or to find out more information, visit www.rubytrial.com.au