Advanced new potential treatments for certain GI diseases affecting millions of patients in need.
Pediatric program in IBS-C & Functional Constipation (FC)
- Functional Constipation affects an estimated 4-6 million 6-17 year-olds in the U.S.1
- The FC study in 6-17 year-olds was well executed, completed enrollment on time, and as of Q3 2022, we now have top line data
- Currently no FDA approved prescribed pediatric therapies for IBS-C and FC
Interstitial Cystitis/Bladder Pain Syndrome and Endometriosis
- Interstitial Cystitis / Bladder Pain Syndrome is a large and growing patient population that affects an estimated 4-12 million people in the U.S.2
- Completed dosing studies in healthy volunteers; expect to start the Phase 2 proof-of-concept study in IC/BPS patients at the end of 2022
- Currently working to finalize the proof-of-concept study design
Primary Biliary Cholangitis (PBC)
- PBC affects an estimated 133,000 people in the U.S.3
- COUR is currently conducting a clinical study with top line data expected to readout in 2023
- Patient enrollment / site activation ongoing
- Introduces a potentially new game-changing therapy for PBC patients in significant need of new treatment options
1Robin, Samantha G. et al, Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the Rome IV Criteria, The Journal of Pediatrics, December 2017; Koppen, I. J. N. et al., Prevalence of Functional Defecation Disorders in Children: A Systemic Review and Meta-Analysis. J Pediatr. 2018. 2Interstitial Cystitis Association, February 2016. 3Kim et al., Epidemiology and Natural History of Primary Biliary Cirrhosis in a US. Community, Gastroenterology July 2000; 199:1631-1636.
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 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.
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.
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