CAMBRIDGE, MA, USA I July 22, 2015 I Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) announced today positive top-line data from a Phase I study of IW-1973, its lead investigational soluble guanylate cyclase (sGC) stimulator. In the study, IW-1973 demonstrated cardiovascular pharmacodynamic effects, extensive tissue distribution, proof of mechanism for sGC stimulation, and a dose range that was well tolerated in healthy volunteers. The totality of clinical and preclinical data generated to date strongly support continued development of IW-1973 as a potential once-daily oral therapy.
Ironwood intends to initiate a Phase Ib multiple ascending dose study of IW-1973 in the fourth quarter of 2015. This study will inform the selection of doses and priority indications for the Phase II program, which will focus on areas with the highest unmet need and optimal path to market. Ironwood intends to initiate at least two Phase II proof of concept studies for IW-1973 in 2016.
“Soluble guanylate cyclase is a fundamental regulator of blood flow, inflammation and fibrosis that is found in a wide range of human tissues – this is why sGC stimulators offer such breadth of therapeutic potential in cardiovascular disease, fibrosis, muscular dystrophy and other disorders,” said Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood. “We look forward to leveraging our established expertise in guanylate cyclases to investigate how the unique properties of IW-1973 observed thus far, such as distribution into target tissues, may allow us to expand the potential of the sGC stimulator class in cardiovascular and other serious diseases.”
The randomized, double-blind, placebo-controlled, single ascending dose Phase I study enrolled 46 healthy volunteers. Participants were randomized 3:1 to receive a single dose of IW-1973 or placebo administered via an oral capsule. Top-line clinical data were consistent with preclinical findings and included cardiovascular pharmacodynamic effects, dose-proportional pharmacokinetics, biomarker-based confirmation of target engagement, and evidence of extensive distribution to tissues. No serious adverse events were reported. Reported adverse events were consistent with the mechanism of action. Data from clinical and preclinical studies of IW-1973 are expected to be presented at a future medical conference.
About IW-1973 and Ironwood’s sGC Platform
IW-1973 is the first clinical compound in Ironwood’s novel chemical series of pharmacologically distinct soluble guanylate cyclase (sGC) stimulators. IW-1973 is expected to advance into a Phase Ib multiple ascending dose study in the fourth quarter of 2015. Ironwood’s second sGC stimulator, IW-1701, is expected to begin a Phase I study also in the fourth quarter of 2015.
The stimulation of sGC is a pharmacologically validated approach with broad therapeutic potential. Found throughout the body, sGC is an enzyme that is activated by the key regulator nitric oxide (NO) and modulates levels of the second messenger cyclic guanosine monophosphate (cGMP), a signaling molecule that regulates fluid homeostasis, blood flow, inflammation and fibrosis. As fundamental regulators of such core physiological processes, sGC modulators may be relevant in 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, and other disorders. Ironwood established its expertise in the cGMP signaling pathway through the discovery and development of linaclotide, a guanylate cyclase C (GC-C) agonist that also modulates cGMP; the company has leveraged its GC-C expertise to discover and patent its broad library of sGC stimulators.
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: 228
CAMBRIDGE, MA, USA I July 22, 2015 I Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) announced today positive top-line data from a Phase I study of IW-1973, its lead investigational soluble guanylate cyclase (sGC) stimulator. In the study, IW-1973 demonstrated cardiovascular pharmacodynamic effects, extensive tissue distribution, proof of mechanism for sGC stimulation, and a dose range that was well tolerated in healthy volunteers. The totality of clinical and preclinical data generated to date strongly support continued development of IW-1973 as a potential once-daily oral therapy.
Ironwood intends to initiate a Phase Ib multiple ascending dose study of IW-1973 in the fourth quarter of 2015. This study will inform the selection of doses and priority indications for the Phase II program, which will focus on areas with the highest unmet need and optimal path to market. Ironwood intends to initiate at least two Phase II proof of concept studies for IW-1973 in 2016.
“Soluble guanylate cyclase is a fundamental regulator of blood flow, inflammation and fibrosis that is found in a wide range of human tissues – this is why sGC stimulators offer such breadth of therapeutic potential in cardiovascular disease, fibrosis, muscular dystrophy and other disorders,” said Mark Currie, Ph.D., chief scientific officer and president of research and development at Ironwood. “We look forward to leveraging our established expertise in guanylate cyclases to investigate how the unique properties of IW-1973 observed thus far, such as distribution into target tissues, may allow us to expand the potential of the sGC stimulator class in cardiovascular and other serious diseases.”
The randomized, double-blind, placebo-controlled, single ascending dose Phase I study enrolled 46 healthy volunteers. Participants were randomized 3:1 to receive a single dose of IW-1973 or placebo administered via an oral capsule. Top-line clinical data were consistent with preclinical findings and included cardiovascular pharmacodynamic effects, dose-proportional pharmacokinetics, biomarker-based confirmation of target engagement, and evidence of extensive distribution to tissues. No serious adverse events were reported. Reported adverse events were consistent with the mechanism of action. Data from clinical and preclinical studies of IW-1973 are expected to be presented at a future medical conference.
About IW-1973 and Ironwood’s sGC Platform
IW-1973 is the first clinical compound in Ironwood’s novel chemical series of pharmacologically distinct soluble guanylate cyclase (sGC) stimulators. IW-1973 is expected to advance into a Phase Ib multiple ascending dose study in the fourth quarter of 2015. Ironwood’s second sGC stimulator, IW-1701, is expected to begin a Phase I study also in the fourth quarter of 2015.
The stimulation of sGC is a pharmacologically validated approach with broad therapeutic potential. Found throughout the body, sGC is an enzyme that is activated by the key regulator nitric oxide (NO) and modulates levels of the second messenger cyclic guanosine monophosphate (cGMP), a signaling molecule that regulates fluid homeostasis, blood flow, inflammation and fibrosis. As fundamental regulators of such core physiological processes, sGC modulators may be relevant in 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, and other disorders. Ironwood established its expertise in the cGMP signaling pathway through the discovery and development of linaclotide, a guanylate cyclase C (GC-C) agonist that also modulates cGMP; the company has leveraged its GC-C expertise to discover and patent its broad library of sGC stimulators.
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: 228
