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Theravance Announces Results From Preclinical Research and Phase 1 Clinical Studies With Investigational Gastrointestinal Motility Compound Presented at 2007 Digestive Disease Week

Posted on: Thursday, 24 May 2007, 18:00 CDT

Theravance, Inc. (NASDAQ: THRX) announced today that results from a series of in vitro and in vivo studies as well as Phase 1 human clinical studies with an investigational gastrointestinal (GI) motility compound, TD-5108, were presented at the 2007 Digestive Disease Week (DDW) in Washington, D.C. DDW is a large scientific meeting where clinical and preclinical scientists and practicing physicians from all over the world meet to share results of investigations and learn about the newest advances in mechanisms and treatment of gastrointestinal diseases.

TD-5108, a highly selective 5-HT4 receptor agonist, was discovered by Theravance through the application of its multivalent drug design in a research program dedicated to finding new treatments for GI motility disorders. TD-5108 is currently in a Phase 2 clinical study for chronic constipation, a condition that affects approximately 5% of the adult population in the United States.

Among the highlights of the TD-5108 studies presented at DDW were:

 --  Results of Phase 1 clinical studies on the single- and multiple-dose     pharmacokinetics and pharmacodynamics of TD-5108 in healthy subjects.     These studies demonstrated that TD-5108 has a pharmacokinetic profile     consistent with once daily dosing and prokinetic activity in healthy     subjects as measured by the time to first bowel movement, frequency of     bowel movements and stool consistency.      --  Studies demonstrating the in vivo preclinical profile of TD-5108     showed that the compound has potent 5-HT4 receptor agonist activity by     several routes of administration, including oral, providing robust     prokinetic activity in the digestive tract of three different animal     species, consistent with its highly potent and selective 5-HT4 receptor     agonist in vitro profile.      --  In vitro studies comparing tegaserod and TD-5108 demonstrated TD-     5108's greater selectivity for 5-HT4 receptors over other 5-HT receptor     types, such as 5-HT2A and 5-HT2B receptors.  These studies also showed TD-     5108's high intrinsic activity at human recombinant 5-HT4 receptors and     native 5-HT4 receptors in isolated rodent and human digestive tract tissue     preparations.      

"The work conducted thus far on TD-5108 has shown this compound to be a full agonist that is highly-selective for the 5-HT4 receptor," said Dr. Patrick Humphrey, Executive Vice President, Research at Theravance. "The compound exhibits prokinetic activity in humans after oral administration and has pharmacokinetic properties, including half-life, that are consistent with once-daily dosing. We look forward to the data from our Phase 2 study, which recently completed enrollment."

About Theravance

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. Of the five programs in development, two are in late stage -- its telavancin program focusing on treating serious Gram-positive bacterial infections with Astellas Pharma Inc. and the Beyond Advair collaboration with GlaxoSmithKline. By leveraging its proprietary insight of multivalency to drug discovery focused on validated targets, Theravance is pursuing a next generation drug discovery strategy designed to discover superior medicines in large markets. For more information, please visit the company's web site at www.theravance.com.

THERAVANCE(R), the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE(R) are registered trademarks of Theravance, Inc.

This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the goals, timing and expected results of clinical and preclinical studies and regulatory review, statements regarding the potential benefits and mechanisms of action of drug candidates, the enabling capabilities of Theravance's approach to drug discovery and its proprietary insights, statements concerning expectations for product candidates through development and commercialization and projections of revenue and other financial items. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to delays or difficulties in commencing or completing clinical and preclinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe, ineffective, inferior or not superior, delays or failure to achieve regulatory approvals, and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading "Risk Factors" contained in Item 1A of Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2007 and the risks discussed in our other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.

 Contact Information:  Allison Parker Director, Investor Relations 650-808-4100 Contact via http://www.marketwire.com/mw/emailprcntct?id=7AA9CCF2D5369260  

SOURCE: Theravance, Inc.

Source: MARKET WIRE

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