Inspire Pharmaceuticals Reports Positive Phase I Results for INS365; Announces New Clinical Collaboration with Cystic Fibrosis Foundation
09:15 a.m. Oct 17, 1998 Eastern

DURHAM, N.C., Oct. 17 /PRNewswire/ -- Inspire Pharmaceuticals, Inc. today announced clinical trial results for INS365, its second respiratory product, in a scientific session at the North American Cystic Fibrosis Conference in Montreal, Canada. The company reported data from a Phase I double-blind, placebo-controlled study of 75 male volunteers, including 35 smokers, that was completed recently in the United Kingdom. According to the data, single inhaled doses of INS365 were safe and well-tolerated, and INS365 was also shown to facilitate the mobilization and clearance of lung secretions.

"INS365 represents a new therapeutic approach to the treatment of cystic fibrosis lung disease, which afflicts more than 23,000 patients in the United States alone, and we are pleased to have advanced this product from a preclinical lead in discovery to the clinic in less than twelve months," said Christy Shaffer, Ph.D., Vice President of Development and Chief Operating Officer for Inspire. "We expect INS365 to promote airway hydration and enhance the natural process of mucociliary clearance, which is markedly impaired in cystic fibrosis patients, and we anticipate that chronic use of this product in early stages of cystic fibrosis lung disease may improve symptoms and patient quality of life and slow the progressive decline in lung function."

INS365 acts on airway cells within the respiratory system, where it activates P2Y2 receptors that regulate the process of mucociliary clearance, the body's natural mechanism for clearing particulate matter and infectious agents from the airways. Inspire has licensed INS365 from the University of North Carolina at Chapel Hill, a preeminent research center in the field of cystic fibrosis.

According to the Phase I data reported by Dr. Shaffer today, the effect of INS365 to mobilize respiratory secretions was generally observed within five to thirty minutes following dosing, and the secretions occurred in a dose-related manner. Cough was the most frequent side effect, which is consistent with the product's mechanism of action -- rapidly mobilizing respiratory secretions.

Inspire also announced plans to conduct a new, multi-center study in cystic fibrosis patients in collaboration with the CF Foundation, through the recently established Therapeutics Development Network (TDN). This network, which is managed by the TDN Coordinating Center in Seattle, Washington, comprises seven U.S. clinical research centers whose primary objective is to develop and conduct early-phase clinical trials of novel therapies for the treatment of cystic fibrosis.

"We expect that our collaboration with Inspire on the INS365 project, coupled with the unique, cooperative approach of TDN's expert sites, will enable therapeutic development of this compound in CF in a highly efficient and effective manner," said Robert J. Beall, Ph.D. President and Chief Executive Officer of the CF Foundation.

The new collaborative trial, a double-blind, placebo-controlled multi-center study to be sponsored by Inspire, and initiated in November, will evaluate the safety and tolerability of four dose levels of INS365 in 48 pediatric and 48 adult patients with mild to moderate CF lung disease.

"We are pleased to be working closely with the TDN Coordinating Center, which is a highly organized group that utilizes state-of-the-art techniques, including electronic data capture, in the clinical trial process," added JoAnn Gorden, Project Manager, Regulatory Affairs for Inspire. "TDN's knowledge and experience will help to maximize the quality of the clinical trials, and we look forward to building upon our relationship with TDN as the clinical program unfolds."

Inspire Pharmaceuticals is focused on the discovery and development of novel therapeutics based on mucosal hydration and epithelial cell biology, and the company currently has two respiratory products in clinical trials and a preclinical project in the ophthalmic area. The members of Inspire's scientific and management team have proven track records in drug discovery and development in the pharmaceutical industry, and in September the company announced a partnership with Kissei Pharmaceutical Co., Ltd. for the development of INS365 for respiratory use. Inspire was established on the basis of inventions developed at the University of North Carolina at Chapel Hill School of Medicine. The company is funded by a prestigious venture capital syndicate that includes Burr, Egan, Deleage & Co., Domain Associates, Medical Science Partners, Benefit Capital Management, and JAFCO Co., Ltd. SOURCE Inspire Pharmaceuticals, Inc.

Copyright 1998, PR Newswire 

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