Prodotti competitors / Area Liver
PBC Competitive Landscape_March 2025 UPDATES
Pipeline
Linerixibat
- GSK hosted its Q4/FY 2024 earnings call and reiterated clinical timelines for linerixibat [press release, presentation, pipeline, webcast] (02/05/25)
- GSK did not discuss linerixibat during the call, nor Q&A, however presentation materials reiterated that the pivotal Ph3 GLISTEN trial (N=238; PCD: Oct 2024) had met its primary endpoint and linerixibat’s Orphan Drug Designation (ODD) in the US and EU
- Previous data from Ph 2b GLIMMER trial demonstrated that linerixibat showed a -1.16 PBO adjusted change in monthly-NRS score after 16 weeks
- US, EU, China regulatory submission acceptances for linerixibat remain expected in H1 2025, and in H2 2025 in Japan. A regulatory decision in the US is still expected in H2 2025
- Regulatory decisions for linerixibat in the EU, China and Japan are now expected in 2026
- GSK did not discuss linerixibat during the call, nor Q&A, however presentation materials reiterated that the pivotal Ph3 GLISTEN trial (N=238; PCD: Oct 2024) had met its primary endpoint and linerixibat’s Orphan Drug Designation (ODD) in the US and EU
- GSK funded a publication, which concluded that an optimal dose can be selected to maximize linerixibat’s ability to improve pruritus while minimizing patient reported diarrhea, suggests GSK may be proactively messaging against linerixibat’s side effect ahead expected approval (02/13/25)
Saroglitazar
- Zydus Lifesciences hosted its Q3 FY25 (YE Mar 2025) earnings call and provided guidance for upcoming catalysts for saroglitazar (PPAR α/γ agonist) [press release, presentation, webcast](02/05/25)
- Zydus highlighted that patient recruitment is complete for the Ph2/3 EPICS-III trial (N=186, PCD: May 2025) assessing saroglitazar in PBC
- The company guided for a Q3 2025 (calendar year) data readout from the Ph2/3 EPICS-III trial, evaluating saroglitazar (PPAR α/γ agonist) in PBC
- During the Q&A, Zydus suggested it might provide an update on commercial plans for saroglitazar following the data readout
- Assuming Zydus files for FDA approval soon after planned data readout in Q3 2025 (calendar year), approval and launch could occur by mid-2026 if priority review is granted
Setanaxib
- Asahi Kaisei released its Q3 FY2024 (YE Mar 2025) financial materials (no mention of setanaxib) [presentation, consolidated results document] (02/05/25)
- There is a low likelihood of continued setanaxib development for PBC given the following: Topline data from the Phase 2b TRANSFORM study (N=76; PCD: May 2024) were “positive” with an ALP reduction of 19% in the 1600mg arm and 14% in the 1200mg arm after 24 weeks (1-year of Livdelzi resulted in a placebo-adjusted ALP reduction of 38%)
- Calliditas was acquired by Asahi Kasei in Sep 2024; Asahi Kasei may not pursue development of setanaxib for PBC, as it is not listed on its pipeline, nor has been mentioned in any earnings calls to-date
- Furthermore, Bank of America reported in Dec 2024 [assumingly based on an interview with Asahi Kasei] that “Asahi Kasei is likely to out-license this drug [setanaxib] to other companies, given its stance on not developing the drug itself”
- Calliditas was acquired by Asahi Kasei in Sep 2024; Asahi Kasei may not pursue development of setanaxib for PBC, as it is not listed on its pipeline, nor has been mentioned in any earnings calls to-date
- There is a low likelihood of continued setanaxib development for PBC given the following: Topline data from the Phase 2b TRANSFORM study (N=76; PCD: May 2024) were “positive” with an ALP reduction of 19% in the 1600mg arm and 14% in the 1200mg arm after 24 weeks (1-year of Livdelzi resulted in a placebo-adjusted ALP reduction of 38%)
Grazie per il tuo feedback!