– Seventh clinical study ongoing in Ironwood pipeline this year –
CAMBRIDGE, MA, USA I March 5, 2015 I Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that dosing has begun in a Phase I clinical study of IW-1973, the first clinical compound in a broad, pharmacologically-differentiated library of soluble guanylate cyclase (sGC) stimulators discovered by Ironwood. Data are expected in the second half of 2015. Ironwood expects to advance a second sGC stimulator, IW-1701, into a Phase I clinical study later this year.
“We look forward to exploring the potential of sGC stimulators across multiple, select therapeutic opportunities within a broad potential range that may span cardiovascular diseases, fibrosis, muscular dystrophy, glaucoma, dementia and diabetic complications,” said Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood. “It is rare in drug discovery to have the opportunity to modulate one of the fundamental regulators in the human body, and we are fortunate to have the pharmacologic expertise to advance what we believe can be strongly differentiated molecules in this space.”
The randomized, double-blind, placebo-controlled Phase I clinical study is designed to assess the safety, pharmacokinetic profile and pharmacodynamic effects of IW-1973 in healthy volunteers.
The IW-1973 Phase I study is the seventh clinical study ongoing in Ironwood’s research and development pipeline this year. Other clinical studies conducted by Ironwood include an ongoing Phase IIa clinical study of IW-9179 in diabetic gastroparesis and a recently completed Phase IIa clinical study of IW-3718 for refractory gastroesophageal reflux disease. Clinical studies ongoing with partners include Phase III trials with linaclotide for adults with irritable bowel syndrome with constipation for China and for Japan, as well as a Phase III trial with a 72 mcg dose of linaclotide in adult patients with chronic idiopathic constipation and a Phase II clinical study of linaclotide for adults with opioid-induced constipation, both in the U.S.
About IW-1973
IW-1973 is an investigational soluble guanylate cyclase (sGC) stimulator discovered by Ironwood. SGC is an enzyme found inside cells throughout the body; it modulates levels of the second messenger cyclic guanosine monophosphate (cGMP), a signaling molecule that regulates many physiological changes and may be relevant for the treatment of a broad range of diseases including cardiovascular diseases such as pulmonary arterial hypertension and congestive heart failure as well as fibrosis, muscular dystrophy, glaucoma, dementia and diabetic complications. Data from preclinical studies of IW-1973 suggest a pharmacokinetic profile consistent with once daily dosing and showed a gradual lowering of blood pressure without profound hypotension or tachycardia in animal models. Ironwood established its expertise with guanylate cyclase C (GC-C), another modulator of cGMP, through the discovery and development of linaclotide; the company then leveraged that GC-C expertise to discover and patent a broad library of chemically distinct sGC stimulators. Ironwood is currently utilizing medicinal chemistry, formulation and pharmacology to drive toward optimizing these molecules for pursuit of various indications and dosing schedules.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is focused on creating medicines that make a difference for patients, building value to earn the continued support of our fellow shareholders, and empowering our team to passionately pursue excellence. We discovered, developed and are commercializing linaclotide, which is approved in the United States and a number of other countries. Our pipeline priorities include exploring further opportunities for linaclotide, as well as leveraging our therapeutic expertise in gastrointestinal disorders and our pharmacologic expertise in guanylate cyclases to address patient needs across the upper and lower gastrointestinal tract. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. Connect with us at www.ironwoodpharma.com or on Twitter at www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
SOURCE: Ironwood Pharmaceuticals
Post Views: 67
– Seventh clinical study ongoing in Ironwood pipeline this year –
CAMBRIDGE, MA, USA I March 5, 2015 I Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that dosing has begun in a Phase I clinical study of IW-1973, the first clinical compound in a broad, pharmacologically-differentiated library of soluble guanylate cyclase (sGC) stimulators discovered by Ironwood. Data are expected in the second half of 2015. Ironwood expects to advance a second sGC stimulator, IW-1701, into a Phase I clinical study later this year.
“We look forward to exploring the potential of sGC stimulators across multiple, select therapeutic opportunities within a broad potential range that may span cardiovascular diseases, fibrosis, muscular dystrophy, glaucoma, dementia and diabetic complications,” said Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood. “It is rare in drug discovery to have the opportunity to modulate one of the fundamental regulators in the human body, and we are fortunate to have the pharmacologic expertise to advance what we believe can be strongly differentiated molecules in this space.”
The randomized, double-blind, placebo-controlled Phase I clinical study is designed to assess the safety, pharmacokinetic profile and pharmacodynamic effects of IW-1973 in healthy volunteers.
The IW-1973 Phase I study is the seventh clinical study ongoing in Ironwood’s research and development pipeline this year. Other clinical studies conducted by Ironwood include an ongoing Phase IIa clinical study of IW-9179 in diabetic gastroparesis and a recently completed Phase IIa clinical study of IW-3718 for refractory gastroesophageal reflux disease. Clinical studies ongoing with partners include Phase III trials with linaclotide for adults with irritable bowel syndrome with constipation for China and for Japan, as well as a Phase III trial with a 72 mcg dose of linaclotide in adult patients with chronic idiopathic constipation and a Phase II clinical study of linaclotide for adults with opioid-induced constipation, both in the U.S.
About IW-1973
IW-1973 is an investigational soluble guanylate cyclase (sGC) stimulator discovered by Ironwood. SGC is an enzyme found inside cells throughout the body; it modulates levels of the second messenger cyclic guanosine monophosphate (cGMP), a signaling molecule that regulates many physiological changes and may be relevant for the treatment of a broad range of diseases including cardiovascular diseases such as pulmonary arterial hypertension and congestive heart failure as well as fibrosis, muscular dystrophy, glaucoma, dementia and diabetic complications. Data from preclinical studies of IW-1973 suggest a pharmacokinetic profile consistent with once daily dosing and showed a gradual lowering of blood pressure without profound hypotension or tachycardia in animal models. Ironwood established its expertise with guanylate cyclase C (GC-C), another modulator of cGMP, through the discovery and development of linaclotide; the company then leveraged that GC-C expertise to discover and patent a broad library of chemically distinct sGC stimulators. Ironwood is currently utilizing medicinal chemistry, formulation and pharmacology to drive toward optimizing these molecules for pursuit of various indications and dosing schedules.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is focused on creating medicines that make a difference for patients, building value to earn the continued support of our fellow shareholders, and empowering our team to passionately pursue excellence. We discovered, developed and are commercializing linaclotide, which is approved in the United States and a number of other countries. Our pipeline priorities include exploring further opportunities for linaclotide, as well as leveraging our therapeutic expertise in gastrointestinal disorders and our pharmacologic expertise in guanylate cyclases to address patient needs across the upper and lower gastrointestinal tract. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. Connect with us at www.ironwoodpharma.com or on Twitter at www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
SOURCE: Ironwood Pharmaceuticals
Post Views: 67
