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Intercept (ICPT) Announces Positive Data From PBC Study
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Intercept Pharmaceuticals, Inc. announced initial results from a planned interim analysis of its ongoing phase II study 747-213.
The comparative study is evaluating the therapeutic potential of the combination of obeticholic acid (OCA) and bezafibrate compared with bezafibrate monotherapy on serum biomarkers in primary biliary cholangitis (PBC).
Patients were randomized 1:1:1:1 to receive 12 weeks of once-daily oral therapy in addition to ongoing UDCA treatment (if any) in one of four treatment arms: bezafibrate 200 mg (B200), bezafibrate 400 mg (B400), bezafibrate 200 mg plus OCA 5 mg titrated to 10 mg at week 4 (OCA5-10/B200) and bezafibrate 400 mg plus OCA 5 mg titrated to 10 mg at week 4 (OCA5-10/B400).
Endpoints included serum biomarkers of PBC-induced liver damage such as alanine transaminase (ALT) and aspartate aminotransferase (AST), as well as markers shown to predict transplant-free survival such as alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and total bilirubin. Safety was assessed by monitoring adverse events (AEs) and laboratory values.
The data from the interim analysis of the ongoing study showed that the combination of OCA 5-10 mg plus bezafibrate 400 mg improved levels of multiple biochemical markers associated with clinical outcomes in PBC, including ALP, total bilirubin, ALT and GGT at 12 weeks.
OCA 5-10 mg + bezafibrate 400 mg also showed a rapid biochemical response of mean ALP to within the normal range at 4 weeks.
The combination was well tolerated, with low rates of pruritus. The rates of pruritus were 25% or less in any treatment arm. Four patients in the study experienced severe or serious treatment-emergent AEs, all of which were deemed not study-drug related.
These data are part of a larger analysis that will be presented later in the month at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria.
Two phase II studies (747-213 / NCT04594694 and 747-214 / NCT05239468) exploring a range of therapeutic doses for the combination of OCA and bezafibrate are ongoing. Intercept expects to complete planned interim analyses from both ongoing phase II studies this year. The results from these studies, in addition to phase I and preclinical data, will serve as the basis for an end-of-phase II meeting with the FDA.
We note that OCA, a farnesoid X receptor (FXR) agonist, is marketed under the brand name Ocaliva by Intercept in the United States for the treatment of PBC, while bezafibrate, a pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, is not approved in the United States for any indication.
Ocaliva’s indication is approved under accelerated approval based on a reduction in ALP. An improvement in survival or disease-related symptoms has not been established.
Intercept’s shares have lost 3.7% in the year so far compared with the industry’s 7.3% decline.
Image Source: Zacks Investment Research
Intercept is also evaluating OCA for other indications.
The company recently suffered a major setback when the FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting voted against the approval of the company’s new drug application (NDA) for OCA for the treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis (NASH) due to concerns about drug-induced liver injury.
Over the past 30 days, estimates for NVO’s 2023 earnings per share have risen by 11 cents to $5.07. Novo Nordisk topped earnings estimates in three of the last four quarters and missed in the remaining one, the four-quarter earnings surprise being 0.35%, on average.
Over the past 30 days, earnings estimates for LGND have increased by 46 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.72 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Intercept (ICPT) Announces Positive Data From PBC Study
Intercept Pharmaceuticals, Inc. announced initial results from a planned interim analysis of its ongoing phase II study 747-213.
The comparative study is evaluating the therapeutic potential of the combination of obeticholic acid (OCA) and bezafibrate compared with bezafibrate monotherapy on serum biomarkers in primary biliary cholangitis (PBC).
Patients were randomized 1:1:1:1 to receive 12 weeks of once-daily oral therapy in addition to ongoing UDCA treatment (if any) in one of four treatment arms: bezafibrate 200 mg (B200), bezafibrate 400 mg (B400), bezafibrate 200 mg plus OCA 5 mg titrated to 10 mg at week 4 (OCA5-10/B200) and bezafibrate 400 mg plus OCA 5 mg titrated to 10 mg at week 4 (OCA5-10/B400).
Endpoints included serum biomarkers of PBC-induced liver damage such as alanine transaminase (ALT) and aspartate aminotransferase (AST), as well as markers shown to predict transplant-free survival such as alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT) and total bilirubin. Safety was assessed by monitoring adverse events (AEs) and laboratory values.
The data from the interim analysis of the ongoing study showed that the combination of OCA 5-10 mg plus bezafibrate 400 mg improved levels of multiple biochemical markers associated with clinical outcomes in PBC, including ALP, total bilirubin, ALT and GGT at 12 weeks.
OCA 5-10 mg + bezafibrate 400 mg also showed a rapid biochemical response of mean ALP to within the normal range at 4 weeks.
The combination was well tolerated, with low rates of pruritus. The rates of pruritus were 25% or less in any treatment arm. Four patients in the study experienced severe or serious treatment-emergent AEs, all of which were deemed not study-drug related.
These data are part of a larger analysis that will be presented later in the month at the European Association for the Study of the Liver (EASL) Congress 2023 in Vienna, Austria.
Two phase II studies (747-213 / NCT04594694 and 747-214 / NCT05239468) exploring a range of therapeutic doses for the combination of OCA and bezafibrate are ongoing. Intercept expects to complete planned interim analyses from both ongoing phase II studies this year. The results from these studies, in addition to phase I and preclinical data, will serve as the basis for an end-of-phase II meeting with the FDA.
We note that OCA, a farnesoid X receptor (FXR) agonist, is marketed under the brand name Ocaliva by Intercept in the United States for the treatment of PBC, while bezafibrate, a pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, is not approved in the United States for any indication.
Ocaliva’s indication is approved under accelerated approval based on a reduction in ALP. An improvement in survival or disease-related symptoms has not been established.
Intercept’s shares have lost 3.7% in the year so far compared with the industry’s 7.3% decline.
Image Source: Zacks Investment Research
Intercept is also evaluating OCA for other indications.
The company recently suffered a major setback when the FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting voted against the approval of the company’s new drug application (NDA) for OCA for the treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis (NASH) due to concerns about drug-induced liver injury.
Zacks Rank and Stocks to Consider
Intercept currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Novo Nordisk (NVO - Free Report) , Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . While both NVO and Ligand sport a Zacks Rank #1 (Strong Buy), NVS carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, estimates for NVO’s 2023 earnings per share have risen by 11 cents to $5.07. Novo Nordisk topped earnings estimates in three of the last four quarters and missed in the remaining one, the four-quarter earnings surprise being 0.35%, on average.
Over the past 30 days, earnings estimates for LGND have increased by 46 cents per share to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 60 days, NVS’ earnings estimates have increased to $6.72 from $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.