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Eyeing a bright future
SAN DIEGO, CALIF.—Shenzhen Relin Medicine and MingSight Pharmaceuticals have formed a joint venture—Jiangsu MingSight-Relin Pharmaceutical—to develop and commercialize MS-553 as an oral therapy for diabetic eye disease in China.
According to the companies, Jiangsu MingSight-Relin Pharmaceutical will adhere to the development standards of both the Chinese SFDA and the U.S. Food and Drug Administration to facilitate the global development of MS-553.
MingSight has licensed MS-553 exclusive rights to MingSight- Relin in China, which it had previously inlicensed from Pfizer.
Such therapies have a potentially huge market in China, which is home to more than 95 million people with diabetes, the highest number in the world, according to figures from the Chinese Diabetes Society. Retinopathy is a condition in chronic diabetes patients whereby retinal blood vessels become damaged and may leak blood, and can be treated through surgery or corticosteroid injections.
Diabetic retinopathy also is one of the most common complications of diabetes and the leading cause of blindness among working adults in the United States. The number of Americans 40 years or older with diabetic retinopathy is expected to triple to 16 million by 2050.
According to Relin General Manager Xintao Xia, as a new chemical entity, MS-553 has demonstrated an excellent potency and safety profile in extensive preclinical studies previously conducted by Pfizer.
"This solid preclinical data forms the basis of our decision to undertake this project," Xia says. "Under the expert guidance from MingSight, the joint venture will conduct preclinical and clinical studies in accordance with international GLP and GCP standards."
As a result, Xia is confident that the collaboration can effectively advance the program through future studies.
Moreover, the partnership combines Relin's track record of leadership in developing, registering and commercializing ophthalmic products in China with MingSight's expertise in ophthalmic drug development.
"We are pleased to collaborate with Shenzhen Relin, a proven leader in China in bringing high value therapies to patients suffering from ophthalmic diseases," adds Kai Zhang, CEO of MingSight. "I look forward to working closely with Relin toward the goal of bringing an innovative therapy for patients with diabetic retinopathy."
MingSight Chief Scientific Officer Michael Niesman explains that MS-553 has shown efficacy and safety in preclinical studies and as an effective and safe oral treatment for diabetic eye disease.
A co-founder of Mingsight, Niesman left academic ophthalmology research in 1998 to join the La Jolla, Calif.-based biotech start-up Agouron Pharmaceuticals Inc. That company was acquired by Warner-Lambert Co. in 1999. Warner-Lambert was subsequently acquired by Pfizer Inc.
Niesman headed Pfizer's ophthalmology research until 2009, when the program was cut by the company as it reorganized its priorities.
After the restructuring, Niesman and some of his colleagues sought opportunities to spin out the ophthalmology assets while they were still part of Pfizer, but the global economic crisis hampered their efforts.
Fate then stepped in as a venture capitalist introduced Niesman to Zhang, a physician with experience in the pharmaceutical industry who was interested in starting a company. The pair then formed MingSight.
Niesman explains that MS-553 is unusual because when it is given orally, it achieves a high concentration in the retina.
"Our hypothesis is that we can achieve that kind of efficacy with an oral treatment, with better compliance and no side effects from the intraocular injection," Niesman says. "An effective and safe oral treatment for diabetic eye disease will be a significant advance for patients, potentially allowing them to avoid invasive therapies that often are given by injections into the eye."
Niesman also explains that the compound involves components to treat both the leakage produced by high glucose blood levels as well as the inflammatory cascade that occurs when the condition becomes chronic, leading to diabetic macular edema.
In diabetic mouse models that received the treatment, MS-553 reduced retinal leakage by 100 percent after just three days. A precedent compound obliterated 95 percent of the retinal leakage induced by vascular endothelial growth factor—one of the key drivers of diabetic eye disease.
The collaboration between Relin and MingSight will be managed by a joint leadership team, consisting of members of senior management from both companies. Financial details of the joint venture were not disclosed.