Drugs / ALT-801
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 2 met primary | ||||||
| Phase 1 | NCT05292911 | Mar → Oct 2022 | NAFLD1 | Altimmune, Inc. | Completed | Met primary |
| Phase 1 | NCT05134662 | Feb 2022 → Feb 2023 | type 2 diabetes mellitus | Altimmune, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05006885 | Sep 2021 → Aug 2022 | NAFLD1 | Altimmune, Inc. | Completed | Met primary |
| Phase 1 | NCT04561245 | Nov 2020 → Oct 2021 | metabolic dysfunction-associated steatohepatitis, obesity disorder | Altimmune, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01478074 | Nov 2011 → Oct 2013 | acute myeloid leukemia | Altor BioScience | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00496860 | May 2007 → Oct 2009 | metastatic malignant neoplasm | Altor BioScience | Completed | No outcome recorded |
| Phase 1/24 trials | ||||||
| Phase 1/2 | NCT01670994 | Aug 2012 → Sep 2015 | refractory plasma cell neoplasm | Altor BioScience | Terminated | No outcome recorded |
| Phase 1/2 | NCT01625260 | Mar 2012 → Mar 2018 | non-invasive bladder urothelial carcinoma | Altor BioScience | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT01326871 | Sep 2011 → Apr 2016 | bladder transitional cell carcinoma, malignant renal pelvis neoplasm, ureter cancer, urethra cancer | Altor BioScience | Completed | No outcome recorded |
| Phase 1/2 | NCT01029873 | Feb 2010 → Nov 2011 | metastatic melanoma | Altor BioScience | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05295875 | Mar 2022 → Sep 2023 | obesity disorder | Altimmune, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2022-01-31 | Altimmune, Inc. | Regulatory Altimmune Announces FDA Clearance of Pemvidutide (ALT-801) IND for Obesity altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its Phase 2 clinical trial of pemvidutide for obesity. |
| 2021-11-09 | Altimmune, Inc. | Results Altimmune Announces Third Quarter 2021 Financial Results and Provides a Corporate Update altimmune.com ↗
Exploratory MRI-PDFF analysis of subjects with hepatic steatosis in recently completed Phase 1 study of pemvidutide shows reduction of liver fat to undetectable levels after 6 weeks of treatment |
| 2021-09-28 | Altimmune, Inc. | Results Altimmune Announces Positive Results From 12-week Phase 1 Clinical Trial of ALT-801 (Pemvidutide) in Overweight and Obese Volunteers altimmune.com ↗
Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced positive results from a 12-week, Phase 1 trial of pemvidutide (proposed INN, formerly known as ALT-801), an investigational glucagon-like peptide-1 (GLP-1)/glucagon dual receptor agonist. |
| 2021-06-16 | Altimmune, Inc. | Results Altimmune Announces Positive Interim Data from ALT-801 Phase 1 Trial in Overweight and Obese Volunteers altimmune.com ↗ |
| 2020-08-26 | Altimmune, Inc. | Results Altimmune Announces Data Presentation on ALT-801, its Balanced and Long-Acting GLP-1/Glucagon Receptor Dual Agonist for NASH, at the Digital International Liver Congress™ 2020 altimmune.com ↗
ALT-801 demonstrated statistically superior reductions (p ≤ 0.05) in body weight, liver weight, plasma ALT, liver triglycerides and cholesterol, plasma cholesterol, NAFLD activity scores, and fibrosis markers compared to semaglutide. |
All press releases naming this drug 9 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALT-801 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01029873 ↗ |
| Action | Activate | “using ALT-801 for ex vivo and in vivo NK cell activation” NCT01478074 ↗ |
| Modality | Protein / enzyme biologic | “ALT-801 is a bifunctional fusion protein comprising interleukin-2 (IL-2) linked to a soluble, single-chain T-cell receptor domain” PMID 21994418 ↗ Oct 2011 |
| Route | Intravenous | “administered by bolus intravenous infusion” NCT00496860 ↗ |
| Target | TP53 | “a TCR domain capable of binding a tumor associated human p53 peptide presented in the context of HLA-A2” NCT01625260 ↗ |