We are progressing our development programs and anticipate reaching new milestones in 2023
Linaclotide Lifecycle Management
Pediatric program in FC & IBS-C
- FC affects an estimated 6 million children & adolescents in the U.S.1
- PDUFA date of June 14th for FC in children and adolescents ages 6-17
- Presenting new linaclotide safety and efficacy data in addressing FC in the pediatric population (6-17) at the Digestive Disease Week meeting in May 2023
- IBS-C post-marketing studies to continue
Primary Biliary Cholangitis (PBC)
- PBC affects an estimated 130,000 people in the U.S.2
- COUR is currently conducting a clinical study with early data assessing T-cell response from patients enrolled expected in the second half of 2023, which we believe will inform timing of topline data and potential option exercise for this program
- Introduces a potentially new game-changing therapy for PBC patients in significant need of new treatment options
Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)
- IC/BPS affects an estimated 4-12 million people in the U.S.3
- Continuing Phase 2 proof of concept study in IC/BPS
- Study designed to evaluate the potential impact of IW-3300 on chronic visceral pain in patients with IC/BPS
Strengthening Our Leading GI Portfolio
In November 2021 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 130,000 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. The proof-of-concept study is ongoing, and given the strong science underlying this therapy, we plan to assess T-cell response in patients dosed with CNP-104 in the second half of 2023, which will inform the timing of topline data.
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. In 2022, we successfully completed dosing studies in healthy volunteers, and are currently executing the proof-of-concept study in IC/BPS. IC/BPS patients are being screened, dosed and site activations are going very well.
Collaboration is a core value and critical to our success.