Ironwood Pharmaceuticals Inc.

IRWD

Held by 2 specialist biotech funds

2 funds opened new positions. Next phase2 readout (IW-6118): Aug 2010. Short interest: 11.5% of float.

Drug Manufacturers - Specialty & GenericCEO: Thomas A. McCourtIPO: 2010Website ↗

Ironwood Pharmaceuticals, Inc., a healthcare company, focuses on the development and commercialization of gastrointestinal (GI) products. It markets linaclotide, a guanylate cyclase type-C agonist for the treatment of adults suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) under the LINZESS name in the United States and Mexico, as well as under the CONSTELLA name in the Canada and European Union. The company is also developing IW-3300, a GC-C agonist for the treatment of visceral pain conditions, including interstitial cystitis/bladder pain syndrome and endometriosis; and CNP-104, an immune nanoparticle for the treatment of biliary cholangitis. The company has strategic partnerships with AbbVie Inc., AstraZeneca AB, and Astellas Pharma Inc. for the development and commercialization of linaclotide. The company was formerly known as Microbia, Inc. and changed its name to Ironwood Pharmaceuticals, Inc. in April 2008. Ironwood Pharmaceuticals, Inc. was incorporated in 1998 and is headquartered in Boston, Massachusetts.

Catalysts

Phase 2Q3 2006MD-1100 AcetateConstipationNCT00306748

Primary: Safety will be evaluated on an ongoing basis by completing physical examinations, ECGs, clinical laboratory tests, and adverse event reporting.Enrollment:Target 40Sites: 14RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q3 2006MD-1100 AcetateIrritable Bowel SyndromeNCT00258193

Primary: (Safety) AEs to be collected beginning with patient's first administration of study medication through final study visitEnrollment:Target 36Sites: 1RANDOMIZED, DOUBLE, TREATMENT

Phase 2Q3 2007MD-0727HypercholesterolemiaNCT00404001

Primary: Low density lipoprotein cholesterol (LDL-C)Enrollment:150/150Sites: 20RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ4 2007linaclotide acetateChronic ConstipationNCT00402337

Primary: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency (Change from Baseline to Week 4)Enrollment:310/310Sites: 60RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2009Matching PlaceboChronic ConstipationNCT00730015

Primary: Complete Spontaneous Bowel Movement (CSBM) Overall Responder (Change from Baseline to Week 12)Enrollment:643/643Sites: 105RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q3 2010IW-6118HealthyNCT01107236

Primary: Safety Assessments (Duration of the Study)Enrollment:90/90Sites: 1RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2010Linaclotide or Matching PlaceboIrritable Bowel Syndrome With ConstipationNCT00938717

Primary: Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks (Change from Baseline to Week 12)Enrollment:805/805Sites: 107RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2012LinaclotideIrritable Bowel Syndrome With Constipation, Chronic ConstipationNCT00730171

Primary: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) (From first dose of open-label study drug up to 78 weeks)Enrollment:1,743/1,743Sites: 116NA, TREATMENT

Phase 2NegativeQ1 2014IW-9179Dyspepsia, Functional Gastrointestinal DisordersNCT01712412

Primary: Rate of treatment-emergent adverse events (Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up)Enrollment:10/10Sites: 15RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ4 2014IW-3718Gastroesophageal RefluxNCT02030925

Primary: Exploratory Endpoints - GERD Symptoms (Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period)Enrollment:93/93Sites: 10RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ3 2015LinaclotideChronic Idiopathic ConstipationNCT02291679

Primary: Percentage of 12-Week CSBM Overall Responders (Week 12)Enrollment:1,223/1,223Sites: 95RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q4 2015IW-9179Diabetic GastroparesisNCT02289846

Primary: Exploratory Endpoint - Daily Severity of Patient-reported Diabetic Gastroparesis Symptoms (Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period)Enrollment:90/90Sites: 22RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2PositiveQ3 2016LinaclotideIrritable Bowel Syndrome With ConstipationNCT02559206

Primary: Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo (Baseline, up to Week 12)Enrollment:759/759Sites: 71RANDOMIZED, QUADRUPLE, TREATMENT

Phase 3PositiveQ1 2019LinaclotideIrritable Bowel Syndrome Characterized by ConstipationNCT03573908

Primary: Overall Change From Baseline in Abdominal Score (Abdominal Bloating, Abdominal Discomfort, and Abdominal Pain) Throughout the Treatment Period (Baseline (14 days before randomization up to the time of randomization), Treatment Period (Weeks 1-12))Enrollment:614/614Sites: 79RANDOMIZED, DOUBLE, TREATMENT

Phase 2PositiveQ1 2020MD-7246Irritable Bowel Syndrome With Diarrhea (IBS-D)NCT03931785

Primary: Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period (Baseline, up to Week 12 (end of the Treatment Period))Enrollment:515/515Sites: 80RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q3 2020IW-3718Gastroesophageal Reflux Disease (GERD)NCT03561883

Primary: Change From Baseline in WHSS at Week 8 (Baseline, Week 8)Enrollment:609/609Sites: 101RANDOMIZED, DOUBLE, TREATMENT

Phase 3NegativeQ4 2020IW-3718Gastroesophageal Reflux Disease (GERD)NCT03561090

Primary: Change From Baseline in WHSS at Week 8 (Baseline, Week 8)Enrollment:495/495Sites: 99RANDOMIZED, DOUBLE, TREATMENT

Phase 2NegativeQ1 2025IW-3300 rectal foamInterstitial Cystitis, Bladder Pain SyndromeNCT05740007

Ironwood Pharmaceuticals Inc.

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