Drugs / Aldafermin
Aldafermin
Trials 14
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2024-01-09 | NGM Biopharmaceuticals, Inc | Regulatory NGM Bio Announces New Clinical Data from Ongoing Trial of NGM707 in Advanced Solid Tumors and Outlines Evolved Strategy for Aldafermin and NGM120 to Focus on Rare Conditions with Significant Unmet Need ngmbio.com ↗
Aldafermin, an engineered FGF19 analog, has been granted Orphan Drug Designation by the FDA for the treatment of primary sclerosing cholangitis (PSC), a rare liver disease |
| 2023-11-13 | NGM Biopharmaceuticals, Inc | Results NGM Bio Presents Positive Phase 2b Results from the ALPINE 4 Trial of Aldafermin in Patients with Compensated Cirrhosis (F4) Due to NASH at AASLD The Liver Meeting® ngmbio.com ↗ |
| 2023-05-08 | NGM Biopharmaceuticals, Inc | Results NGM Bio Announces Presentation of Data from Phase 2 Investigator-Sponsored Trial of Aldafermin for the Treatment of Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) and Bile Acid Malabsorption (BAM) at Digestive Disease Week 2023 ngmbio.com ↗ |
| 2023-05-04 | NGM Biopharmaceuticals, Inc | Results NGM Bio Reports First Quarter 2023 Financial Results and Provides Business Highlights, Including Topline ALPINE 4 Data ngmbio.com ↗
Today NGM Bio is reporting topline data from the Phase 2b ALPINE 4 trial of aldafermin in 160 patients with compensated cirrhosis due to NASH (liver fibrosis stage 4, or, F4). |
| 2021-05-24 | NGM Biopharmaceuticals, Inc | Results NGM Bio Reports Topline Results from 24-Week Phase 2b ALPINE 2/3 Study of Aldafermin in NASH ngmbio.com ↗
Study did not meet primary endpoint of fibrosis improvement by >1 stage with no worsening of NASH versus placebo |
| 2020-08-29 | NGM Biopharmaceuticals, Inc | Results NGM Bio Presents Comprehensive Findings from 24-Week Phase 2 Study (Cohort 4) of Aldafermin in Oral Plenary Presentation at The Digital International Liver Congress™ (ILC) 2020 and Announces Enrollment Completed in Phase 2b ALPINE 2/3 Study ngmbio.com ↗
The 24-week Phase 2 study met its primary endpoint, achieving a statistically significant reduction in liver fat content (LFC), and robust fibrosis improvement and resolution of NASH, with a favorable safety profile |
| 2020-02-24 | NGM Biopharmaceuticals, Inc | Results NGM Bio Announces Positive Preliminary Topline Liver Histology and Biomarker Data from 24-Week Phase 2 Study (Cohort 4) of Aldafermin in NASH Patients, Including Statistically Significant Achievement of Composite Endpoint of Both Fibrosis Improvement and Resolution of NASH versus Placebo ngmbio.com ↗
22% of aldafermin-treated patients versus 0% placebo achieved composite endpoint of both fibrosis improvement and resolution of NASH, a statistically significant result |
| 2019-10-07 | NGM Biopharmaceuticals, Inc | Results NGM Bio Announces Positive Interim Results from Ongoing 24-Week Phase 2 Study Evaluating Aldafermin (NGM282) in Patients with NASH ngmbio.com ↗
Treatment with aldafermin 1 mg resulted in statistically significant reductions in absolute and relative liver fat at 24 weeks compared to placebo |
| 2018-11-09 | NGM Biopharmaceuticals, Inc | Results NGM Bio Announces New Histology Data from Phase 2 Trial of NGM282 in Patients with NASH ngmbio.com ↗
The new data reveal that treatment with 1 mg doses of NGM282 resulted in a rapid and robust impact on both fibrosis stage and disease activity as measured by the non-alcoholic fatty liver disease (NAFLD) activity score (NAS) at 12 weeks. |
| 2018-04-14 | NGM Biopharmaceuticals, Inc | Results NGM Bio Announces Results From Phase 2 Study Of NGM282 In Nash Patients Demonstrating Clinically Significant Improvements In Liver Histology After 12 Weeks ngmbio.com ↗
NGM Bio, a leading biotech company developing a portfolio of clinical-stage product candidates that modulate novel or previously intractable targets implicated in metabolic and other serious diseases, today announced data from a Phase 2 study of its lead product candidate, NGM282, demonstrating clinically meaningful improvements in histological measures of disease in nonalcoholic steatohepatitis (NASH) patients at twelve weeks. |
| 2018-04-13 | NGM Biopharmaceuticals, Inc | Results NGM Bio Announces Late-Breaking Plenary Presentation At International Liver Conference 2018 Of Detailed Results From Phase 2 Study Of NGM282 In Patients With Primary Sclerosing Cholangitis ngmbio.com ↗
As previously reported, the randomized, double-blind, placebo-controlled Phase 2 study did not meet its primary endpoint of statistically significant change in alkaline phosphatase (ALP), a presumptive biomarker of PSC disease progression, from baseline to week 12. |
| 2018-03-12 | NGM Biopharmaceuticals, Inc | Results NGM Bio Announces Publication In The Lancet Of Phase 2 Study Of NGM282 In NASH Patients And Upcoming Presentations Of NGM282 NASH Histology Data And NGM282 PSC Data At The International Liver Congress 2018 ngmbio.com ↗
The Lancet publishes findings from groundbreaking 12-week Phase 2 study of NGM282 in non-alcoholic steatohepatitis (NASH) patients employing non-invasive measures of disease activity |
| 2018-02-05 | NGM Biopharmaceuticals, Inc | Results NGM Reports Top-Line Results From Phase 2 Study Of NGM282 In Patients With Primary Sclerosing Cholangitis (PSC) ngmbio.com ↗ |
| 2017-04-22 | NGM Biopharmaceuticals, Inc | Results NGM Bio Announces NGM282 Dramatically Reduced Liver Fat and Other Biomarkers Associated with Nonalcoholic Steatohepatitis (NASH) in Phase 2 Trial ngmbio.com ↗
NGM Bio announced that its lead product candidate, NGM282, met the primary endpoint and key secondary endpoints in a Phase 2 trial of patients with nonalcoholic steatohepatitis (NASH). |
| 2017-04-05 | NGM Biopharmaceuticals, Inc | Results NGM Bio to Present Phase 2 Data of NGM282 in NASH at International Liver Congress 2017 ngmbio.com ↗
Patients with biopsy-confirmed NASH treated with NGM282 for 12 weeks showed rapid and highly significant reductions in magnetic resonance imaging (MRI) measures of liver fat content and serum biomarkers of liver function and fibrosis. |
| 2015-11-09 | NGM Biopharmaceuticals, Inc | Results NGM Bio to Present Data Highlighting the Therapeutic Potential of NGM282 in Cholestatic Liver Diseases at AASLD’s The Liver Meeting® 2015 ngmbio.com ↗
These data suggest that new biologic pathways may offer novel treatment options for patients that are unresponsive to the current treatments and at the greatest risk for complications of cirrhosis. |
| 2015-03-24 | NGM Biopharmaceuticals, Inc | Results NGM Biopharmaceuticals Announces Positive Phase 2 Clinical Data in Primary Biliary Cirrhosis Patients for NGM282, a First-in-Class Investigational Medicine ngmbio.com ↗
NGM282, an engineered protein variant of the human hormone FGF19, demonstrated statistically significant, dose-dependent and clinically meaningful reductions in alkaline phosphatase (ALP), a primary indicator of disease activity, as well as substantial reductions in 7α-Hydroxy-4-cholesten-3-one (C4), a marker of bile acid synthesis. |
All press releases naming this drug 26 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Aldafermin | “The aim of this study was to evaluate the safety and efficacy of aldafermin, an engineered analogue of the gut hormone fibroblast growth factor 19 (FGF19).” PMID 35325622 ↗ Mar 2022 |
| Known as | Aldafermina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298055 ↗ |
| Known as | Aldafermine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298055 ↗ |
| Known as | NGM282 | “Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects With...” NCT04210245 ↗ |
| Modality | Protein / enzyme biologic | “a lead FGF19 analog, NGM282” PMID 30862680 ↗ Mar 2019 |
| Route | Subcutaneous | “to receive either 3 mg or 6 mg subcutaneous NGM282 or placebo” PMID 29519502 ↗ Mar 2018 |