This development is a progression from a binding letter of intent in May for Zhaoke to have the exclusive rights to IC-265 for dry eye and IC-270 for allergic conjunctivitis in China and other countries in Southeast Asia.
The agreement enables unprecedented drug development cooperation between both companies. This includes the sharing of existing and future data and regulatory documents, access to existing or soon-to-be-produced drug materials and expedited regulatory and development plans in territories including, but not limited to, China, Hong Kong, Macau, Singapore, Thailand and Vietnam.
Damon Burrows, the CEO of Iacta, told BioWorld that the license encompasses both development and commercialization in Chinese and Southeast Asian markets, “We anticipate phase II studies for both 265 and 270 to be complete in 18 months,” he said.
“IC-265 is a Syk kinase inhibitor which, along with other kinase inhibitors, are cutting edge therapies being studied for multiple therapeutic areas. IC-265 generated exciting anti-inflammatory data in a phase II allergy model suggesting that it will treat dry eye,” said Burrows.
Since Syk is the critical starting point in the activation of the inflammatory or immune cascade in the eye, the Syk kinase inhibitor is able to block multiple downstream signaling pathways leading to different ophthalmic ailments, including dry eye. The candidate is currently in phase II development in U.S. for the treatment of dry eye.
“IC-270 is the Syk kinase inhibitor combined with a commercially available antihistamine that has the potential to be a leading allergy medicine that can treat itch, redness and the inflammatory effect associated with an allergic response,” said Burrows.
Zhaoke believes that the unique combination that make up IC-270 will simultaneously address multiple key inflammatory symptoms in the eye in a manner unavailable to current therapies. It will be spearheading its clinical development activities and those of IC-265 required for regulatory approval in those markets.
Zhaoke is a subsidiary of Lee's Pharmaceutical Holdings Ltd. “Because Lee’s Pharma is a publicly traded company in Hong Kong, we are unable to share financial information at this time. However, the economics of this partnership will allow us to accelerate the development of these two assets,” said Burrows.
Iacta has hailed the collaboration as ideal, with Zhaoke contributing strong Asian commercialization and regulatory experience. “This partnership combined with the global clinical and regulatory strength of our CRO partner, Ora Inc., and Iacta's drug development expertise creates an extremely strong global R&D platform for developing not only IC-265 and IC-270 but also additional therapies in the future," said Steve Johnson, Iacta’ chief operating officer.
The partnership will allow Iacta to draw on a global data set to accelerate its own regulatory approvals in the U.S., said Burrows.
According to Iacta, the global prevalence of dry eye is estimated to be around 344 million and the estimated size of the global market is about $7.7 billion by 2025.
The company also estimates the incidence rate of dry eye in China to be between 21% to 30%. The figures are similar in other Asian countries and higher than that in Europe and the U.S.
The northwestern regions of China such as Shaanxi, Qinghai, Xinjiang can have rates of up to 59%. Iacta said the high incidence rates represent a significant commercial opportunity in China and the popularity of smartphones and computers also helps fuel the surrounding Asian markets.