SOUTH SAN FRANCISCO, CA, USA and BOLOGNA, Italy I January 8, 2013 I Theravance, Inc. ( NASDAQ : THRX ) and Alfa Wassermann S.p.A. announced today the initiation of a Phase 2 proof-of-concept study with velusetrag, Theravance’s investigational 5-HT4 agonist, for the treatment of patients with diabetic or idiopathic gastroparesis.
"We are pleased to be advancing the clinical development of velusetrag in a Phase 2 gastroparesis study," said Mathai Mammen, M.D., Ph.D., Senior Vice President of Research and Early Clinical Development of Theravance. "Today, patients have limited options for treating this serious, debilitating, and chronic condition."
About Phase 2 Study 0093
Study 0093 is a multicenter, randomized, double-blind, incomplete block, three-period fixed sequence crossover, Phase 2 study. This proof-of-concept study will assess three oral doses of velusetrag (5, 15, and 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in approximately 32 patients with diabetic or idiopathic gastroparesis. The primary endpoint of the study is gastric emptying time. Secondary endpoints include safety and tolerability assessments.
About Gastroparesis
Gastroparesis is a serious, debilitating disorder of gastrointestinal (GI) motility with few therapeutic options currently available to patients. It is characterized by delayed gastric emptying in the absence of a mechanical obstruction. Symptoms experienced by patients with gastroparesis include early satiety, nausea, vomiting, and bloating. The impact of these symptoms, and the uncertainty of knowing when a symptom will occur, can make living with this condition very difficult.
About Velusetrag
Velusetrag, also known as TD-5108, is a highly selective agonist with high intrinsic activity at the human 5-HT4 receptor. An oral, investigational medicine dosed once daily, velusetrag has completed a 400-patient Phase 2 proof-of-concept study in chronic idiopathic constipation, demonstrating statistically significant prokinetic activity at all three doses tested; at the two lowest doses, velusetrag was generally well tolerated with a low incidence of adverse events. Velusetrag has also been shown to accelerate gastric emptying in healthy volunteers. Velusetrag was discovered by Theravance through the application of its multivalent drug design in a research program dedicated to finding new treatments for gastrointestinal motility disorders.
About Partnership
In October 2012, Theravance and Alfa Wassermann entered into a development and commercialization agreement for velusetrag, in development for gastrointestinal motility disorders. Under the agreement, the companies will collaborate in the execution of a two-part Phase 2 program, funded by Alfa Wassermann, to test the efficacy, safety and tolerability of velusetrag in the treatment of patients with gastroparesis. Alfa Wassermann has an exclusive option to develop and commercialize velusetrag in the European Union, Russia, China, Mexico and certain other countries. Theravance retains full rights to velusetrag in the United States, Canada, Japan and certain other countries.
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. 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 central nervous system (CNS)/pain. Theravance’s key programs include: RELVAR™ or BREO™ (FF/VI), ANORO™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance’s web site at www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.
RELVAR™ or BREO™ (FF/VI) and ANORO™ (UMEC/VI) are investigational medicines and are not currently approved anywhere in the world. RELVAR™, BREO™ and ANORO™ are trademarks of the GlaxoSmithKline group of companies. The use of these brand names has not yet been approved by any regulatory authority.
About Alfa Wassermann
Alfa Wassermann is a private pharmaceutical group with Head Quarters in Bologna, Italy with its own research, development and manufacturing facilities. It has a growing number of affiliate companies in both Europe as well as in emerging markets such as Russia, China and Mexico. Its main product is rifaximin, a gut-selective antibiotic, which has been prescribed for 24 years under the Trade Name Normix®, Xifaxan® and others (approved in 33 countries, including the US). The company has also developed other important products: Sulodexide (Vessel®), a heparinoid for thromboembolic diseases, and Parnaparin (Fluxum®), a low molecular weight heparin for the treatment and prophylaxis of deep-vein thrombosis. For more information, please visit Alfa Wassermann’s web site at www.alfawassermann.it.
SOURCE: Alfa Wassermann
Post Views: 185
SOUTH SAN FRANCISCO, CA, USA and BOLOGNA, Italy I January 8, 2013 I Theravance, Inc. ( NASDAQ : THRX ) and Alfa Wassermann S.p.A. announced today the initiation of a Phase 2 proof-of-concept study with velusetrag, Theravance’s investigational 5-HT4 agonist, for the treatment of patients with diabetic or idiopathic gastroparesis.
"We are pleased to be advancing the clinical development of velusetrag in a Phase 2 gastroparesis study," said Mathai Mammen, M.D., Ph.D., Senior Vice President of Research and Early Clinical Development of Theravance. "Today, patients have limited options for treating this serious, debilitating, and chronic condition."
About Phase 2 Study 0093
Study 0093 is a multicenter, randomized, double-blind, incomplete block, three-period fixed sequence crossover, Phase 2 study. This proof-of-concept study will assess three oral doses of velusetrag (5, 15, and 30 mg) or placebo, administered once daily in three periods of 1-week duration each, with a 1-week washout period between treatment periods, in approximately 32 patients with diabetic or idiopathic gastroparesis. The primary endpoint of the study is gastric emptying time. Secondary endpoints include safety and tolerability assessments.
About Gastroparesis
Gastroparesis is a serious, debilitating disorder of gastrointestinal (GI) motility with few therapeutic options currently available to patients. It is characterized by delayed gastric emptying in the absence of a mechanical obstruction. Symptoms experienced by patients with gastroparesis include early satiety, nausea, vomiting, and bloating. The impact of these symptoms, and the uncertainty of knowing when a symptom will occur, can make living with this condition very difficult.
About Velusetrag
Velusetrag, also known as TD-5108, is a highly selective agonist with high intrinsic activity at the human 5-HT4 receptor. An oral, investigational medicine dosed once daily, velusetrag has completed a 400-patient Phase 2 proof-of-concept study in chronic idiopathic constipation, demonstrating statistically significant prokinetic activity at all three doses tested; at the two lowest doses, velusetrag was generally well tolerated with a low incidence of adverse events. Velusetrag has also been shown to accelerate gastric emptying in healthy volunteers. Velusetrag was discovered by Theravance through the application of its multivalent drug design in a research program dedicated to finding new treatments for gastrointestinal motility disorders.
About Partnership
In October 2012, Theravance and Alfa Wassermann entered into a development and commercialization agreement for velusetrag, in development for gastrointestinal motility disorders. Under the agreement, the companies will collaborate in the execution of a two-part Phase 2 program, funded by Alfa Wassermann, to test the efficacy, safety and tolerability of velusetrag in the treatment of patients with gastroparesis. Alfa Wassermann has an exclusive option to develop and commercialize velusetrag in the European Union, Russia, China, Mexico and certain other countries. Theravance retains full rights to velusetrag in the United States, Canada, Japan and certain other countries.
About Theravance
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies. 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 central nervous system (CNS)/pain. Theravance’s key programs include: RELVAR™ or BREO™ (FF/VI), ANORO™ (UMEC/VI) and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc, and its oral Peripheral Mu Opioid Receptor Antagonist program. By leveraging its proprietary insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet medical need. For more information, please visit Theravance’s web site at www.theravance.com.
THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.
RELVAR™ or BREO™ (FF/VI) and ANORO™ (UMEC/VI) are investigational medicines and are not currently approved anywhere in the world. RELVAR™, BREO™ and ANORO™ are trademarks of the GlaxoSmithKline group of companies. The use of these brand names has not yet been approved by any regulatory authority.
About Alfa Wassermann
Alfa Wassermann is a private pharmaceutical group with Head Quarters in Bologna, Italy with its own research, development and manufacturing facilities. It has a growing number of affiliate companies in both Europe as well as in emerging markets such as Russia, China and Mexico. Its main product is rifaximin, a gut-selective antibiotic, which has been prescribed for 24 years under the Trade Name Normix®, Xifaxan® and others (approved in 33 countries, including the US). The company has also developed other important products: Sulodexide (Vessel®), a heparinoid for thromboembolic diseases, and Parnaparin (Fluxum®), a low molecular weight heparin for the treatment and prophylaxis of deep-vein thrombosis. For more information, please visit Alfa Wassermann’s web site at www.alfawassermann.it.
SOURCE: Alfa Wassermann
Post Views: 185
