Primary Sclerosing Cholangitis (PSC) is a chronic progressive cholestatic disease of the liver characterized by inflammation and strictures of the biliary tree inside and/or outside the liver. The pathological hallmarks of PSC include injury to the integrity of the biliary ducts, retention of bile acids and intrahepatic inflammation and progressive liver fibrosis.
Chemomab is Testing the Novel Biologic Drug, CM-101, Which it has Developed for Treating PSC:
- CM-101 targets the soluble protein CCL24, which was found to play a pivotal role in promoting fibrotic and inflammatory activities in the liver through its receptor, CCR3
- Chemomab has demonstrated that CCL24 is strongly expressed in PSC patients’ liver samples (biopsies), while its levels in the blood correlate with the state of liver fibrosis
Chemomab conducted pre-clinical tests of CM-101 in multiple PSC animal models, and found that CM-101 was effective and significantly attenuated disease severity.
Chemomab also tested CM-101 in healthy volunteers and patients with non-alcoholic fatty liver disease (NAFLD) and found CM-101 to be safe and well tolerated in all tested doses. In the current study, for the first time, Chemomab will evaluate CM-101 for treating PSC patients. The SPRING study will test CM-101 activity, safety and tolerability in adult PSC patients.
This is a phase 2a study, administering 5 intravenous infusions once every 3 weeks over 12 weeks of either the tested drug (CM-101) or placebo.
-
Key Eligibility Criteria
- Males and females, 18 to 75 years of age
- Patient has been diagnosed via MRCP/ERCP with large-duct PSC (intrahepatic and/or extrahepatic) and has had the condition for at least 24 weeks
- ALP level must be > 1.5 ULN
- Patients with a diagnosis of concomitant IBD are eligible to participate, however, their IBD must be in remission
- UDCA treatment is allowed at doses below 23 mg/kg/day and stable for at least 12 weeks
- Patients with biliary drain or bile duct stents are not eligible
- Patients’ concomitant medications must be stable for at least 12 weeks
SPRING Study Procedures
-
Screening
4 weeks
-
Treatment Period
12 weeks: Drug administration
once every 3 weeks,
for a total of 5 treatments -
Safety Follow-Up Visit
3 weeks after last treatment
Participants will sign an informed consent form and will be screened to make sure they are eligible to join the study.
If eligible, participants will be randomly assigned to receive IV infusions of the study drug or a placebo. Participants will visit the study site once every 3 weeks for 12 weeks of treatment. An additional interim safety visit will take place 7 days after the first treatment. Three weeks after the last dose, participants will visit the clinic for a follow-up appointment. This study does not involve liver biopsies.
In total, each study participant will visit the testing site 7 times over 5 months.
Study initiation: Q3 2020 - This Study is Not Yet Open for Recruitment
Locations
-
Hadassah Medical Center
Kiryat Hadassah, Ein Kerem, Jerusalem
-
Rabin Medical Center
39 Jabotinski St., Petah Tikva 49100
-
Soroka University Medical Center
Ben Gurion Avenue, Beer-Sheva