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

Action

agonists

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 3

First Approval Date-

RegulationFast Track (United States)

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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.

01 Sep 2024·Indian journal of endocrinology and metabolism

Approved and Emerging Hormone-Based Anti-Obesity Medications: A Review Article

Review

Author: Kalra, Sanjay ; Kalhan, Atul ; Sidrak, Wael R.

Abstract:

Obesity is a heterogeneous, complex, and chronic disease that has a detrimental impact on disability-adjusted life years across the globe. Recent advancements in our understanding of gut-brain communication at the molecular level have driven the development of next-generation anti-obesity medications (AOMs). Glucagon-like peptide-1 receptor agonists (GLP1RAs) remain the front-runners in this rapidly evolving landscape of hormone-based AOMs. Two GLP1RAs, namely Liraglutide and Semaglutide, have been approved by the Food and Drug Administration (FDA) and European Medicine Agency (EMA) for use in clinical practice for weight loss. Three oral GLP1RAs, namely Semaglutide, Danuglipron, and Orforglipron, are undergoing advanced clinical trials in individuals with obesity. Amylin receptor agonist (AMYRA) Cagrilintide, when used alone or in combination with Semaglutide, has demonstrated substantial weight reduction in clinical trials. Tirzepatide, a dual agonist for the glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors, has been observed to be associated with a significant placebo-subtracted weight reduction of 17.8% in a 72-week randomized controlled trial. Novel approaches targeting glucagon signalling have also yielded promising preliminary results. Three long-acting GLP1R/glucagon receptor (GCGR) dual agonists, namely Survodutide, Mazdutide, and Pemvidutide, exhibited significant weight loss in clinical trials. Retatrutide, a GLP1R/GCGR/GIPR tri-agonist, has been associated with a placebo-subtracted weight reduction of -22.1% in a 48-week phase-II trial. As a note of caution, long-term data on such medications’ safety and cardiovascular benefits is yet to be ascertained. Our review provides a comprehensive overview of the approved and emerging hormone-based AOMs, highlighting the diversity of options that might become available in the near future.

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.

120

News (Medical) associated with Pemvidutide

14 Mar 2025

·endpts.com

Altimmune to put its incretin into addiction trials; Tarsus aims to raise $125M

Plus, news about Heidelberg, Accropeutics, Allarity Therapeutics, Cadrenal and Inovio: Altimmune to test its incretin in addiction : Following the path set by Novo Nordisk last week , Altimmune said Thursday at its R&D Day that it plans to begin trials of its injectable GLP-1/glucagon agonist pemvidutide in alcohol use disorder as well as alcoholic liver disease. Stifel analysts wrote in a note on Thursday that Altimmune has animal data that suggest pemvidutide could reduce daily alcohol intake by around half. They also cautioned that additional data would be needed to validate the hypothesis. — Elizabeth Cairns Tarsus Pharmaceuticals’ expected $125 million stock sale: The drugmaker said the funds from the public offering will be used to support the US commercialization of Xdemvy, eye drops for irritation caused by tiny mites. Tarsus also said the funds will be used to advance its experimental ocular rosacea and lyme disease drugs. — Lei Lei Wu Heidelberg amends royalty deal: The company signed an agreement with HealthCare Royalty a year ago to provide royalties to Zircaix, or TLX250-CDx, an imaging agent for some kidney cancers. While the total value of the milestones remains the same at $90 million, the companies changed the deal so that Heidelberg will receive $20 million immediately rather than get $15 million as a sales milestone. They also reduced the FDA approval milestone to $70 million from $75 million. (That milestone will be further reduced if approval comes after 2025.) Heidelberg licensed the drug to Telix in 2017, and a rolling FDA submission was initiated in 2023. — Max Gelman Accropeutics raises $12M to fund IBD asset : The Series B-plus round was led by Shenzhen Capital Group and is set to extend the biotech’s cash runway into the second half of next year. The proceeds will be used for the ongoing Phase 1b trial of Accropeutics’ RIPK2 inhibitor, known as AC-101, in ulcerative colitis. Accropeutics also has a mid-stage TYK2/JAK1 inhibitor in development for psoriasis and a RIPK1 inhibitor for graft-versus-host disease. — Elizabeth Cairns Allarity Therapeutics settles with SEC: The company will pay $2.5 million to the Securities and Exchange Commission after the regulator alleged Allarity executives concealed from investors that the FDA had recommended against approving dovitinib, an experimental cancer therapy. The company did not admit or deny the allegations. — Jaimy Lee Cadrenal is still seeking a partner for tecarfarin: It wants help advancing the oral vitamin K antagonist into a pivotal trial for patients with left ventricular assist devices and other rare cardiovascular conditions. — Jaimy Lee Inovio’s DNA therapy is durable in early trial : The company said Thursday that a Phase 1 trial proves the concept of its so-called DMAbs. The DNA plasmids encoding antibodies derived from Evusheld, AstraZeneca’s Covid-19 prophylactic, were given to patients and were translated into the proteins by the patient’s own cells. All subjects who reached week 72 had biologically relevant levels of the antibodies, according to Inovio, and the expressed DMAbs bound to the SARS-CoV-2 spike protein confirmed functional activity. However, the company did not say whether the approach prevented infections . — Elizabeth Cairns

Phase 1Clinical Result

29 Jan 2025

·www.globenewswire.com

Altimmune to Participate in the Guggenheim SMID Cap Biotech Conference

GAITHERSBURG, Md., Jan. 29, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that members of the Company’s management team will participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference. Details are as follows: Conference:Guggenheim SMID Cap Biotech Conference Date/Time:Wednesday, February 5, 2025, at 9:30 a.m. EST The session will be webcast and can be accessed by visiting the Events section of the Altimmune website. 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

PDC

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

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 3	United States	Altimmune, Inc.	-
Obesity	Phase 3	United States	Altimmune, Inc.	-
Diabetes Mellitus, Type 2	Phase 1	United States	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	nksjvuekzi(oczjnasjpt) = izhquolrye opsbguuopa (lfjpuqgwfg ) 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)	xtbuezkjyo = fwlyjtirda xdvhclitua (scoqwcsyqb, deludqeyhj - whaivqskek) View more	-	19 Jul 2024
				Gemcitabine+ALT-801 (0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine)	xtbuezkjyo = fecvewpemz xdvhclitua (scoqwcsyqb, lnjeviwnle - odtzbnojwp) 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	ckncfxszpb(qrijclkuzk) = pousopkuso hbastqbffc (kclibaqebk, -63.7 to -29.6)	Positive	01 Jul 2024
				Pemvidutide 1.8 mg	ckncfxszpb(qrijclkuzk) = cuynpiifvm hbastqbffc (kclibaqebk, -84.4 to -52.5) View more
NCT05295875 (MOMENTUM, GlobeNewswire) Manual	Phase 2	Obesity	391	Pemvidutide 1.2 mgPemvidutide 1.2 mg	eqhnszjxze(wrqpihbqmq) = dbpoqxrbvf cgucywmfrp (jctchujdkz )	Positive	23 Jun 2024
				Pemvidutide 1.8 mgPemvidutide 1.8 mg	eqhnszjxze(wrqpihbqmq) = jzmnxxvpyv cgucywmfrp (jctchujdkz )
ADA2024	Not Applicable	Overweight \| Obesity	-	Pemvidutide 1.2 mg	mfzixqvkps(kjbwtrjjlp) = 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 dmdafxqjrz (paiudclvsk )	-	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)	xcxfxgauwd = afgvgpiyet lrqigfdnel (ymvpihabvq, qqhybubsjs - fbopgcpzik) View more	-	18 Jun 2024
				ALT-801 (ALT-801 0.06mg/kg)	xcxfxgauwd = bcskyafewx lrqigfdnel (ymvpihabvq, rfpspelabq - rmlnfyuurq) View more
ADA2024	Not Applicable	Lipid Metabolism Disorders	-	Pemvidutide 1.2 mg	dcpeikgmsh(jzjwwnxtoh) = Reduction in GlycA, biomarker of systemic inflammation correlated with heart failure, were also observed uquedagnlq (giafxnbzar ) View more	-	14 Jun 2024
				Pemvidutide 1.8 mg
NCT05295875 (MOMENTUM, NEWS) Manual	Phase 2	Overweight \| Obesity	391	pemvidutide 1.2mg	lczxpwjjnj(txeziboblf) = fohtafsgzo wimbxjkzui (ratdovuhgj, 1.4) View more	Positive	02 Dec 2023
				pemvidutide 1.8mg	lczxpwjjnj(txeziboblf) = oayyjuptsn wimbxjkzui (ratdovuhgj, 1.4) View more
NCT05292911 (Corporate Publications) Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease	64	Pemvidutide 1.2mg	fcrnrgeaoc(ksvsvvdtry) = imrzftmbds lqvgvafyvx (sxzmbukina ) View more	Positive	13 Nov 2023
				Pemvidutide 1.8mg	fcrnrgeaoc(ksvsvvdtry) = gnqcfmwayl lqvgvafyvx (sxzmbukina ) View more
NEWS Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease	94	placebo	wgaibbhvec(rzlzsojzmf) = yikoiyxfgd dsxvsvvqba (kkamlpaaqf ) View more	Positive	25 Oct 2023
				pemvidutide 1.2 mg	wgaibbhvec(rzlzsojzmf) = bjpbczydjy dsxvsvvqba (kkamlpaaqf ) View more

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