DURHAM, North Carolina--Parion Sciences, Inc. and Kainos Medicines, Inc. have announced entering into an agreement to codevelop Parion's proprietary epithelial sodium channel blocker, P-552, for the treatment of dry mouth associated with primary Sjogren's syndrome.
Under the agreement, the companies will collaborate in the clinical development of P-552. Kainos will provide funding to help advance the program through the end of Phase II clinical testing, supplying up to $25 million upon completion of all milestones.
Parion will be responsible for the oversight of the clinical development program while Kainos will provide CMC (chemistry, manufacturing and controls) expertise. Upon successful completion of the Phase II program, Parion and Kainos will determine the Phase III clinical development and commercialization of P-552.
In a Phase I/II clinical study completed in April 2008, P-552 was found to be safe and tolerable in subjects with primary Sjogren's disease. The study demonstrated promising results in several quality of life parameters, including mouth dryness, mouth comfort and ability to sleep, as assessed by Visual Analogue Scale.
"Sjogren's syndrome patients are seeking effective relief of their dry mouth. By combining the talents and expertise of two proven development teams, we believe we can accelerate the clinical development of P-552 to effectively address this unmet need," said M. Ross Johnson, Parion chief executive officer.
"This partnership represents the second application of our portfolio of sodium channel blockers as we continue to expand Parion's unique technology and novel compound library into other diseases requiring mucosal hydration."
"I am very pleased that Kainos and Parion will be working together on the development of P-552," said M.C. Kang, Kainos chief executive officer. "Strategically, each partner brings its complementary expertise to the collaboration. This will provide a comprehensive and complete development program for P-552 and support the business strategy of Kainos Medicines."
Epithelial sodium channel (ENaC) blockers, such as P-552, are unique therapeutic agents developed to maintain and stimulate hydration on the body's mucosal surfaces, including those of the lung, mouth, nose, eye and gastrointestinal tract. Improving the mucosal hydration in the mouth addresses quality of life problems associated with oral dryness caused by Sjogren's syndrome.
Sjogren's syndrome is a chronic disorder that occurs when a person's immune system attacks and destroys moisture-producing glands, including the salivary and tear glands. There are currently no specific topical pharmaceutical medications to alleviate the symptoms of dry mouth associated with Sjogren's syndrome.
The syndrome can cause difficulty with chewing and swallowing, decreased sense of taste, hoarseness, coughing and an increase in dental cavities.
For more information about Parion Sciences, visit Parion Sciences.
To read more Sjogren's syndrome, go to Sjogren's syndrome.
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