Okogen, Inc., a developer of ophthalmic anti-infectives has secured Ora, Inc., the leading ophthalmic Contract Research Organization, to conduct the clinical studies and lead the regulatory strategy of OKG-0301 for the treatment of adenoviral conjunctivitis. OKG-0301, Okogen’s lead candidate, is an ophthalmic formulation of a potent ribonuclease with broad-spectrum antiviral properties. Adenoviral conjunctivitis is the primary cause of eye infections globally, lasting typically 2-3 weeks.
“Viral conjunctivitis, the most common cause of pink eye, remains a significant unmet medical need. While there are diagnostics for adenoviral conjunctivitis, there are still no approved therapies to treat this highly contagious disease,” said David A. Hollander, M.D., Chief Medical Officer of Ora. “A safe and effective antiviral that reduces the duration of patient symptoms and the period in which patients may infect others around them would likely significantly impact current practice standards.”
In a clinically predictive rabbit model of adenoviral conjunctivitis, OKG-0301 significantly reduced viral titers of infected eyes in addition to shortening the duration of viral shedding compared to controls. OKG-0301 demonstrated a clear dose-dependent response, enabling predictive optimization of ongoing dosing protocols.
“We are thrilled to collaborate with Ora’s deeply knowledgeable and experienced team as we complete preclinical development and move OKG-0301 into the clinic,” said Brian M. Strem, Ph.D., Chief Executive Officer of Okogen. “Ora has a proven track record of advancing drug development for adenoviral conjunctivitis and broadly across all indications in ophthalmology.”
OKG-0301 is based on an active pharmaceutical ingredient (API) that previously advanced to late stage clinical trials in oncology. As an IV formulation, this API has been administered to over 800 patients as part of this clinical testing, in addition to a significant amount of work in preclinical toxicology and CMC. These data highlight a strong safety profile as well as a validated, commercial-scale manufacturing process that will accelerate OKG-0301’s path to the clinic. To share more about Okogen’s recent developments, on January 9, 2017, the company will be presenting a corporate update at the Biotech Showcase Conference in San Francisco, California.
About Adenoviral Conjunctivitis
Worldwide, adenoviral conjunctivitis is the most common eye infection and affects up to 25 million individuals, annually. The condition is a leading ocular disease driving patients to seek treatment. Most cases For Immediate Release
involve eye redness with varying degrees of swelling and some component of ocular discharge. This is accompanied by clinical symptoms including pain, itching, and a foreign body sensation. The infection lasts for 2-3 weeks and patients generally remain contagious for 10-14 days. Transmission to family members or close contacts is very common and patients are advised to avoid work and/or school until symptoms fully resolve.
Okogen is a biotechnology company focused on developing therapeutics to help patients with ocular infections. The lead candidate is OKG-0301, a potent, broad-spectrum antiviral that functions intracellularly to inhibit viral replication. This mechanism of action provides opportunity to address 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, picornavirus, and more. For more information about Okogen, visit www.okogen.com.
Ora is the world’s leading full-service ophthalmic CRO and product development firm with offices in the United States, the United Kingdom and Japan. Over the past 40 years, we helped our clients earn 44 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora’s pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects. We bring together the world’s most extensive and experienced team of ophthalmic experts and R&D professionals to maximize the value of new product initiatives. For more information about Ora, please go to www.oraclinical.com, follow us on LinkedIn (http://bit.ly/1TgHErs), follow @oraclinical on Twitter, or like us on Facebook (/Ora-Inc).
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Brian M. Strem
Chief Executive Officer