Delving into the Latest Updates on Pemvidutide with Synapse

Overview

Basic Info

Drug Type

Synthetic peptide

Synonyms

ALT-801, ALT-801- Altimmune, MD-1373

+ [2]

Target

GCGR x GLP-1R

Mechanism

GCGR agonists(Glucagon receptor agonists), GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Digestive System DisordersEndocrinology and Metabolic Disease

Active Indication

Nonalcoholic SteatohepatitisObesityDiabetes Mellitus, Type 2

Inactive Indication-

Originator Organization-

Active Organization

Altimmune, Inc.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationFast Track (US)

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Structure/Sequence

Sequence Code 28085928

Source: *****

Patients with a BMI ≥28.0 kg/m² and LFC ≥10% by magnetic resonance imaging-proton density fat fraction were randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks. Participants were stratified according to a diagnosis of type 2 diabetes mellitus. The primary efficacy endpoint was relative reduction (%) from baseline in LFC after 12 weeks of treatment.

RESULTS:

Ninety-four patients were randomized and dosed. Median baseline BMI and LFC across the study population were 36.2 kg/m² and 20.6%; 29% of patients had type 2 diabetes mellitus. At week 12, relative reductions in LFC from baseline were 46.6% (95% CI -63.7 to -29.6), 68.5% (95% CI -84.4 to -52.5), and 57.1% (95% CI -76.1 to -38.1) for the pemvidutide 1.2 mg, 1.8 mg, and 2.4 mg groups, respectively, vs. 4.4% (95% CI -20.2 to 11.3) for the placebo group (p <0.001 vs. placebo, all treatment groups), with 94.4% and 72.2% of patients achieving 30% and 50% reductions in LFC and 55.6% achieving normalization (≤5% LFC) at the 1.8 mg dose. Maximal responses for weight loss (-4.3%; p <0.001), alanine aminotransferase (-13.8 IU/L; p = 0.029), and corrected cT1 (-75.9 ms; p = 0.002) were all observed at the 1.8 mg dose. Pemvidutide was well-tolerated at all doses with no severe or serious adverse events.

CONCLUSIONS:

In patients with MASLD, weekly pemvidutide treatment yielded significant reductions in LFC, markers of hepatic inflammation, and body weight compared to placebo.

IMPACT AND IMPLICATIONS:

Metabolic dysfunction-associated steatotic liver disease, and its progressive form steatohepatitis, are strongly associated with overweight/obesity and it is believed that the excess liver fat associated with obesity is an important driver of these diseases. Glucagon-like peptide-1 receptor (GLP-1R) agonists elicit weight loss through centrally and peripherally mediated effects on appetite. Unlike GLP-1R agonists, glucagon receptor agonists act directly on the liver to stimulate fatty acid oxidation and inhibit lipogenesis, potentially providing a more potent mechanism for liver fat content reduction than weight loss alone. This study demonstrated the ability of once-weekly treatment with pemvidutide, a dual GLP-1R/glucagon receptor agonist, to significantly reduce liver fat content, hepatic inflammatory activity, and body weight, suggesting that pemvidutide may be an effective treatment for both metabolic dysfunction-associated steatohepatitis and obesity.

CLINICAL TRIAL NUMBER:

NCT05006885.

15 Dec 2011·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Phase I Trial of ALT-801, an Interleukin-2/T-Cell Receptor Fusion Protein Targeting p53 (aa264–272)/HLA-A*0201 Complex, in Patients with Advanced Malignancies

Q1 · MEDICINE

Article

Author: Wong, Hing C. ; Thompson, John A. ; Diez, Luz M. ; Huang, Bee Y. ; Fishman, Mayer N. ; Tang, Shamay ; Daud, Adil I. ; Pennock, Gregory K. ; Weber, Jeffery S. ; Rhode, Peter R. ; Gonzalez, Rene

Abstract:

Purpose: ALT-801 is a bifunctional fusion protein comprising interleukin-2 (IL-2) linked to a soluble, single-chain T-cell receptor domain that recognizes a peptide epitope (aa264–272) of the human p53 antigen displayed on cancer cells in the context of HLA-A*0201 (p53+/HLA-A*0201). We evaluated the safety, pharmacokinetics, and pharmacodynamics of ALT-801 in p53+/HLA-A*0201 patients with metastatic malignancies.Experimental Design: p53+/HLA-A*0201 patients were treated with ALT-801 on a schedule of four daily 15-minute intravenous infusions, then 10 days rest and four more daily infusions. Cohorts of patients were treated at 0.015, 0.040, and 0.080 mg/kg/dose.Results: Four, 16, and 6 patients were treated at the 0.015, 0.04, and 0.08 mg/kg cohorts, respectively. Two dose-limiting toxicities (a grade 4 transient thrombocytopenia and a myocardial infarction) in the 0.08 mg/kg cohort established the maximum tolerated dose (MTD) at 0.04 mg/kg. Patients treated at the MTD experienced toxicities similar to those associated with high-dose IL-2 but of lesser severity. The serum half-life of ALT-801 was 4 hours and ALT-801 serum recovery was as expected based on the dose administered. ALT-801 treatment induced an increase of serum IFN-γ but not TNF-α. Response assessment showed 10 subjects with stable disease at at least 11 weeks, and in one who had melanoma metastasis, there is an ongoing complete absence of identifiable disease after resection of radiographically identified lesions.Conclusion: This first-in-man study defines an ALT-801 regimen that can be administered safely and is associated with immunologic changes of potential antitumor relevance. Clin Cancer Res; 17(24); 7765–75. ©2011 AACR.

Scientific reportsQ3 · CROSS-FIELD

Effects of ALT-801, a GLP-1 and glucagon receptor dual agonist, in a translational mouse model of non-alcoholic steatohepatitis

Q3 · CROSS-FIELD

ArticleOA

Author: Nestor, John J ; Feigh, Michael ; Harris, M Scott ; Parkes, David ; Suschak, John J

Abstract:

Body weight loss of ≥ 10% improves the metabolic derangements and liver disease in the majority of non-alcoholic steatohepatitis (NASH) patients, suggesting metabolic modulators may be effective in controlling disease. The pharmacodynamics of ALT-801, a GLP-1/glucagon receptor dual agonist optimized for NASH and weight loss, were compared to semaglutide (GLP-1 receptor agonist) and elafibranor (peroxisome proliferator-activated receptor, PPAR-α/δ, agonist) in a biopsy-confirmed, diet-induced obese (DIO) mouse model of NASH (DIO-NASH). Male C57BL/6J mice were fed Amylin Liver NASH (AMLN) diet for 32 weeks. Animals with biopsy-confirmed steatosis and fibrosis received ALT-801, semaglutide, elafibranor, or vehicle daily for 12 weeks while maintained on the AMLN diet. Study endpoints included body and liver weight, liver and plasma total cholesterol and triglycerides, plasma aminotransferases, histological analysis of liver steatosis, inflammation (galectin-3) and fibrosis (collagen type 1 alpha 1), and evaluation of individual animal changes in composite Non-alcoholic Fatty Liver Disease Activity Score (NAS), and fibrosis stage. ALT-801 demonstrated significant reductions in body weight (approx. 25%), plasma aminotransferases, plasma total cholesterol and liver triglycerides/total cholesterol in conjunction with improved liver steatosis, with greater reductions (p < 0.05) compared to semaglutide and elafibranor. ALT-801 significantly reduced the inflammation marker galectin-3 and the fibrosis marker collagen type 1 alpha 1 vs. vehicle (p < 0.05), with ALT-801 producing greater reductions in galectin-3 vs. elafibranor (p < 0.05). Importantly, all animals treated with ALT-801 significantly improved composite NAS compared to the active controls. This study provides evidence for a potential role for ALT-801 in the therapeutic treatment of NASH.

110

News (Medical) associated with Pemvidutide

19 Dec 2024

·ir.altimmune.com

Altimmune Added to Nasdaq Biotechnology Index

GAITHERSBURG, Md., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it will be added to the Nasdaq Biotechnology Index (Nasdaq: NBI) effective prior to the market open on Monday, December 23, 2024. “Our addition to the NBI is an important recognition to conclude what has been a year of major progress for the Company,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “With a number of significant inflection points coming in 2025, including the topline data from the Phase 2b IMPACT trial of pemvidutide in MASH in the second quarter, we believe that we are well positioned heading into the new year.” Established in 1993, the Nasdaq Biotechnology Index is designed to track the performance of a set of Nasdaq-listed securities that are classified as either Biotechnology or Pharmaceutical according to the Industry Classification Benchmark (ICB). Companies in the NBI must meet certain eligibility requirements, including market capitalization, average daily trading volume and seasoning. The Index is evaluated annually and serves as the basis for the iShares NASDAQ Biotechnology Index Fund (Nasdaq: IBB). For more information about the NASDAQ Biotechnology Index, visit: https://indexes.nasdaqomx.com/Index/Overview/NBI. About Pemvidutide Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss with class-leading lean mass preservation, and robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial. About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedIn Follow @AltimmuneInc on Twitter Company Contact: Greg Weaver Chief Financial Officer Phone: 240-654-1450 ir@altimmune.com Investor Contact: Lee Roth Burns McClellan Phone: 646-382-3403 lroth@burnsmc.com Media Contact: Danielle Cantey Inizio Evoke, Biotech Phone: 619-826-4657 Danielle.cantey@inizioevoke.com This press release was published by a CLEAR® Verified individual. Source: Altimmune, Inc

Phase 2Fast TrackClinical Result

02 Dec 2024

·www.globenewswire.com

Altimmune to Present at the Cachexia Regulatory & Trials Update Workshop of the 17th International Conference of the Society on Sarcopenia, Cachexia & Wasting Disorders

GAITHERSBURG, Md., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that Dr. Scott Harris, Chief Medical Officer at Altimmune, will present body composition data from the Phase 2 MOMENTUM trial of pemvidutide in the treatment of obesity and participate in a panel discussion at the Cachexia Regulatory & Trials Update Workshop of the 17th International Conference of the Society on Sarcopenia, Cachexia & Wasting Disorders in Washington, D.C. Details for the panel discussion are as follows: Title:Muscle Wasting in Weight Loss TherapySession:Treatment Approaches to Address Muscle Wasting in the Context of Obesity Therapy & Regulatory IssuesPresenter:Scott Harris, M.D., Chief Medical Officer, Altimmune, Inc.Date/Time:Friday, December 6, 2024 at 9:30 am ET About Altimmune Altimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on Twitter Company Contact:Greg WeaverChief Financial OfficerPhone: 240-654-1450ir@altimmune.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com This press release was published by a CLEAR® Verified individual.

Phase 2

26 Nov 2024

·www.globenewswire.com

Altimmune to Participate at Two Upcoming Investor Conferences

GAITHERSBURG, Md., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that members of the Company’s management team will participate and be available for 1x1 meetings at the following investor conferences: Annual Evercore HealthCONx Conference (Coral Gables, FL)Tuesday, December 3, 2024Fireside Chat at 10:50 a.m. Eastern Time Piper Sandler Annual Healthcare Conference (New York, NY)Wednesday, December 4, 2024Fireside Chat at 3:30 p.m. Eastern Time The sessions will be webcast and can be accessed by visiting the Events section of the Altimmune website. About AltimmuneAltimmune is a clinical-stage biopharmaceutical company focused on developing innovative next-generation peptide-based therapeutics. The Company is developing pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of obesity and MASH. For more information, please visit www.altimmune.com. Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on Twitter Company Contact:Greg WeaverChief Financial OfficerPhone: 240-654-1450ir@altimmune.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com This press release was published by a CLEAR® Verified individual.

100 Deals associated with Pemvidutide

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	Phase 2	US	Altimmune, Inc.	27 Jul 2023
Nonalcoholic Steatohepatitis	Phase 2	AU	Altimmune, Inc.	27 Jul 2023
Nonalcoholic Steatohepatitis	Phase 2	PR	Altimmune, Inc.	27 Jul 2023
Obesity	Phase 2	US	Altimmune, Inc.	31 Mar 2022
Diabetes Mellitus, Type 2	Phase 1	US	Altimmune, Inc.	01 Feb 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05292911 (GlobeNewswire) Manual	Phase 2	Obesity	67	Pemvidutide	wdvbfutjbi(otscdeybwu) = efvurvxrur ekmkykzqgr (ahiozrkhon ) View more	Positive	10 Sep 2024
NCT01625260 (CTgov)	Phase 1/2	Non-Muscle Invasive Bladder Neoplasms	12	Gemcitabine+ALT-801 (0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine)	mqyyqjaxbm(mynsfusyoz) = egpuithxfs enmuvbrrjp (iyihlkkcpw, mopqucuyco - uuzqcjuvpc) View more	-	19 Jul 2024
				Gemcitabine+ALT-801 (0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine)	mqyyqjaxbm(mynsfusyoz) = obsdljfhfu enmuvbrrjp (iyihlkkcpw, wvwzfluaxg - fqbedrarmr) View more
NCT05006885 (Pubmed \| J Hepatol) Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus (T2DM)	94	Pemvidutide 1.2 mg	keusqnsvnh(iklxrqopwa) = ymwtdtwkve lapmefxrhh (vxmnijrmwn, -63.7 to -29.6)	Positive	01 Jul 2024
				Pemvidutide 1.8 mg	keusqnsvnh(iklxrqopwa) = wysazwtklv lapmefxrhh (vxmnijrmwn, -84.4 to -52.5) View more
NCT05295875 (MOMENTUM, GlobeNewswire) Manual	Phase 2	Obesity	391	Pemvidutide 1.2 mgPemvidutide 1.2 mg	pzvrrdgyya(cxdowegyla) = syqqmgbkuv gcbgsiybkc (fozldwjtxv )	Positive	23 Jun 2024
				Pemvidutide 1.8 mgPemvidutide 1.8 mg	pzvrrdgyya(cxdowegyla) = sttxslmcle gcbgsiybkc (fozldwjtxv )
ADA2024	Not Applicable	Overweight \| Obesity	-	Pemvidutide 1.2 mg	ejnyumvwqf(kwilkuwznh) = Most adverse events were mild to moderate with only 1 drug-related SAE; glycemic control (glucose, HbA1c) was maintained with minimal increases in heart rate ldgwjzbdof (fhlitxytdv )	-	23 Jun 2024
				Pemvidutide 1.8 mg
NCT01670994 (CTgov)	Phase 1/2	Relapse multiple myeloma \| Refractory Multiple Myeloma	6	ALT-801 (ALT-801 0.04mg/kg)	jdktblahto(bdqafxhrqh) = zckoglomux lqgvtflizk (xwyhhdqzdg, psrtsolqsm - phslnsugxy) View more	-	18 Jun 2024
				ALT-801 (ALT-801 0.06mg/kg)	jdktblahto(bdqafxhrqh) = pnsitzifey lqgvtflizk (xwyhhdqzdg, cxjtamcogd - avrxqshbsk) View more
ADA2024	Not Applicable	Lipid Metabolism Disorders	-	Pemvidutide 1.2 mg	cvxvvooztx(bkqouvcfkp) = Reduction in GlycA, biomarker of systemic inflammation correlated with heart failure, were also observed ciapwnbmjx (avltyqwrtp ) View more	-	14 Jun 2024
				Pemvidutide 1.8 mg
NCT05295875 (MOMENTUM, NEWS) Manual	Phase 2	Overweight \| Obesity	391	pemvidutide 1.2mg	isyqijihlx(jwcflbdpwf) = gqcnrhfwiw wzxhcfgsqz (gikrcuymth, 1.4) View more	Positive	02 Dec 2023
				pemvidutide 1.8mg	isyqijihlx(jwcflbdpwf) = lgidnxvfkk wzxhcfgsqz (gikrcuymth, 1.4) View more
NCT05292911 (Corporate Publications) Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease	64	Pemvidutide 1.2mg	ytzdkxotfb(jxatowjvbl) = nvtkrokrbu pwslczwhnm (zalnnrnnzw ) View more	Positive	13 Nov 2023
				Pemvidutide 1.8mg	ytzdkxotfb(jxatowjvbl) = bnanbhuipu pwslczwhnm (zalnnrnnzw ) View more
NEWS Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease	94	placebo	ehvuetqrez(wuhnhclysq) = ssbzblhacz gikutcgkgz (crxvciamsu ) View more	Positive	25 Oct 2023
				pemvidutide 1.2 mg	ehvuetqrez(wuhnhclysq) = kvqwtqausc gikutcgkgz (crxvciamsu ) View more