Parion Sciences And Kainos Medicines Sign Clinical Development Agreement For Novel Dry Mouth Treatment

Main Category: Ear, Nose and Throat
Article Date: 28 Oct 2008 - 11:00 PDT

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Kainos to Fund Up to $25 Million to Advance P-552

Parion Sciences, Inc. and Kainos Medicines, Inc. today announced that they have entered into an agreement to co-develop 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 the 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 key quality of life parameters including mouth dryness, mouth comfort and ability to sleep, as assessed by Visual Analogue Scale (VAS).

"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.

What is 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, which can cause difficulty with chewing and swallowing, decreased sense of taste, hoarseness, coughing and an increase in dental cavities.

About Parion Sciences

Based in Durham, NC, Parion Sciences is a privately-held, development-stage pharmaceutical company that is leveraging its proprietary small molecule chemistry and epithelial biology expertise to discover and develop an innovative pipeline of therapies for diseases resulting from the failure of the body's mucosal defenses, including chronic obstructive pulmonary disorder (COPD), cystic fibrosis, bronchiactesis and Sjogren's syndrome. Parion's lead product candidate, P-552, is currently in Phase II clinical development for the treatment dry mouth associated with Sjogren's syndrome. The company is also collaborating with Gilead Sciences on the development of drug candidates for pulmonary diseases. For more information, please visit http://www.parion.com.

About Kainos Medicines

Based in Seoul, South Korea, Kainos Medicines is a privately-held company that focuses on the in-licensing and development through proof of concept of diverse and promising, early-stage drug candidates for clinically relevant targets. Subsequent to proof of concept, the company will seek strategic partnerships to complete the development of successful drug candidates through global regulatory approval and commercialization. Kainos Medicines USA, Inc., based in Morrisville, NC, provides the preclinical and clinical development activities to obtain the safety and efficacy data for the Kainos drug candidates.

Kainos Medicines