US company Okogen launches Australian clinical trial

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US-based biopharmaceutical company Okogen has announced the launch of Phase 2 trials that will see its lead therapy tested in patients with conjunctivitis across Australia.

The RUBY trial 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. It is the number one cause of eye infections globally.

Patients affected by the disease suffer eye redness with swelling and ocular discharge, accompanied by symptoms including pain, itching, and foreign body sensation.

Bacterial conjunctivitis is typically treated with antibiotics including eye drops or ointments. These do not work in treating viral forms of the infection and there are no approved therapies for the disease.

The infection can persist for up to three weeks and patients are highly contagious for 10-14 days. 

“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 negatives outcomes on eye health,” said Okogen CEO Brian M. Strem.

“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 will evaluate multiple doses of OKG-0301 in 219 adult patients with acute adenoviral conjunctivitis.

Professor Stephanie Watson of Save Sight Institute and The University of Sydney is the principle investigator coordinating the trials.

“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,” said Professor Watson. 

In December 2017, Okogen announced a $13 million investment in Series A Funding from Brandon Capital’s Medical Research Commercialisation Fund (MRCF) to advance its development of OKG-0301.