Ironwood Pharmaceuticals
Responsibility

Patients & Research

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We put patients at the center of everything we do.

This includes ensuring access to treatments and care, expanding our GI portfolio, engaging with patients, and conducting responsible research.

Linaclotide

We continue our efforts to widen the reach of Linaclotide and address unmet patient need. Ironwood and our U.S. collaboration partner are currently advancing the linaclotide clinical pediatric program to evaluate its safety and efficacy and potentially expand it’s clinical profile to pediatric patients 6-17 with FC.

Strengthening Our Leading GI Portfolio

CNP-104

We expanded our pipeline by entering into a collaboration and license option agreement with COUR Pharmaceuticals Development Company, Inc., which grants us an option to acquire an exclusive license to research, develop, manufacture and commercialize, in the U.S., products containing CNP-104, a potential treatment for PBC, a rare autoimmune disease targeting the liver that affects an estimated 133,000 people in the U.S. according to a study published in Gastroenterology. Currently, there is no approved therapy that addresses the root cause of the autoimmune destruction of the bile ducts in PBC. In December 2021, COUR received U.S. Fast Track Designation. COUR has initiated a clinical study for CNP-104 to evaluate the safety, tolerability, pharmacodynamic effects and efficacy of CNP-104 in PBC patients, with a data readout estimated in the second half of 2023.

IW-3300

We are developing our wholly owned IW-3300 – a GC-C agonist - for the potential treatment of visceral pain conditions, such as interstitial cystitis/bladder pain syndrome (IC/BPS) and endometriosis. IC/BPS affects an estimated 4 to 12 million Americans, according to the Interstitial Cystitis Association. An estimated 4 million reproductive-age women in the U.S. have been diagnosed with endometriosis, according to a study published in Gynecologic and Obstetric Investigation. Both diseases have a limited number of treatment options available. We are continuing study start up activities and plan to finalize the Phase II proof of concept study design in IC/BPS by the end of 2022, with patient enrollment expected in early 2023.

Patient Engagement

We believe in bringing diverse patient voices to the forefront of what we do, and we are committed to reducing healthcare inequities. In 2021, we sponsored a workshop with the International Foundation for Gastrointestinal Disorders (IFFGD) focused on improving communication between physicians and patients living with GI disease. We also partnered with the digital platform PatientsLikeMe to bolster support for patient advocacy. Our clinical trials are designed to minimize patient burden and improve access to investigational drugs by all demographics.

Responsible Research

Clinical Research Data Sharing

We meet industry and scientific standards in our clinical trial publication and data sharing practices, and we believe providing access to such data strengthens opportunities for further scientific development and collaboration. All clinical trials results, including the results of terminated trials, when required, are published on clinicaltrials.gov.

To uphold our commitments to patient privacy, we have implemented and maintain a Clinical Research Data Sharing Policy, which requires that individual participant data that underlie the results reported in any publication of any Ironwood clinical study will be shared only after deidentification.

Animal Welfare

We are committed to the ethical use of animals in medical research. All animal studies are carefully reviewed by an Institutional Animal Care and Use Committee (IACUC) which is charged with ensuring that a proposed study is essential. We comply with the “Three Rs” (Replace, Reduce and Refine), widely accepted ethical principles that are embedded in the conduct of animal-based science.

Collaborating Opportunities

As a GI focused, US healthcare company, we are interested in identifying opportunities to collaborate on GI products. Please contact [email protected] for partnership inquiries. Learn more about grant and sponsorship opportunities.

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2021 Environment, Social, and Governance Report Cover
To read further please
view our 2021 report.
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