Product Code: DMKC0185608
Primary sclerosing cholangitis (PSC) is a progressive, rare, and chronic cholestatic liver disorder that is characterized by thickening, inflammation, and fibrosis of the bile ducts. Both intra- and extra-hepatic bile ducts are affected. This generally leads to cholestasis, liver cirrhosis, and eventually liver failure.
- Datamonitor Healthcare estimates that in 2019, there were 241,800 prevalent cases of primary sclerosing cholangitis (PSC) worldwide among adults aged 30 years and over, and forecasts that number to increase to 277,300 prevalent cases by 2028. The majority of industry-sponsored drugs in active clinical development for PSC are in Phase II, with only two drugs in Phase III. Therapies in the pipeline for PSC focus on a wide variety of targets. The majority of pipeline drugs in development are administered via the oral route, with the remainder being tested in intravenous and subcutaneous formulations.
- The only high-impact upcoming event for drugs in the PSC space is topline Phase II trial results for PLN-74809. The overall likelihood of approval of a Phase I autoimmune/immunology-other asset is 22.3%, and the average probability a drug advances from Phase III is 71.7%. Drugs, on average, take 9.8 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.
- The distribution of clinical trials across Phase I-IV indicates that the majority of trials for PSC have been in the early and midphases of development, with 80% of trials in Phase I-II, and only 20% in Phase III.
- The US leads in terms of the number of PSC clinical trials globally, while the UK leads the major European markets.
- Gilead Sciences has two completed trials and two ongoing trials in PSC.
- Gilead Sciences has conducted two Phase II trials for PSC, as well as a single trial in Phase I and in Phase III.
TABLE OF CONTENTS
RECENT EVENTS AND ANALYST OPINION
- Seladelpar for PSC (November 25, 2019)
- Cilofexor for PSC (November 9, 2018)
KEY UPCOMING EVENTS
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- BiomX Acquires PSC Targets From Japanese University
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
LIST OF FIGURES
- Figure 1: Trends in prevalent cases of PSC, 2019-28
- Figure 2: Overview of pipeline drugs for PSC in the US
- Figure 3: Pipeline drugs for PSC, by company
- Figure 4: Pipeline drugs for PSC, by drug type
- Figure 5: Pipeline drugs for PSC, by classification
- Figure 6: Cilofexor for PSC (November 9, 2018): Phase II - Without Cirrhosis
- Figure 7: Key upcoming events in PSC
- Figure 8: Probability of success in the PSC pipeline
- Figure 9: Clinical trials in PSC
- Figure 10: Top 10 drugs for clinical trials in PSC
- Figure 11: Top 10 companies for clinical trials in PSC
- Figure 12: Trial locations in PSC
- Figure 13: PSC trials status
- Figure 14: PSC trials sponsors, by phase
LIST OF TABLES
- Table 1: Prevalent cases of PSC, 2019-28
- Table 2: Pipeline drugs for PSC in the US
- Table 3: Seladelpar for PSC (November 25, 2019)
- Table 4: Cilofexor for PSC (November 9, 2018)