A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)

Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.

Start Date27 Jul 2023

Sponsor / Collaborator

Altimmune, Inc.

NCT05295875 / CompletedPhase 2

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled and Parallel Group 48-Week Study to Evaluate the Efficacy and Safety of ALT-801 in the Treatment of Obesity (MOMENTUM Trial)

This study will evaluate the efficacy and safety of ALT-801 once-weekly versus placebo as an adjunct to a reduced-calorie diet and increased physical activity in patients with obesity/overweight.

Start Date31 Mar 2022

Sponsor / Collaborator

Altimmune, Inc.

NCT05292911 / CompletedPhase 1

A 12-Week Extension Study of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)

This extension study will assess the safety and effects of 24 weeks of treatment with ALT-801 in diabetic and non-diabetic subjects with overweight and obesity and non-alcoholic fatty liver disease (NAFLD).

Start Date09 Mar 2022

Sponsor / Collaborator

Altimmune, Inc.

100 Clinical Results associated with Pemvidutide

100 Translational Medicine associated with Pemvidutide

100 Patents (Medical) associated with Pemvidutide

Literatures (Medical) associated with Pemvidutide

01 Jul 2024·JOURNAL OF HEPATOLOGY

Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study

Article

Author: Browne, Sarah K ; Harrison, Stephen A ; Gutierrez, Julio A ; Roberts, M Scot ; Suschak, John J ; Harris, M Scott ; Yang, Jay ; Tomah, Shaheen

BACKGROUND & AIMS:

This was a randomized, double-blind, placebo-controlled study to assess the effects of pemvidutide, a glucagon-like peptide-1 (GLP-1)/glucagon dual receptor agonist, on liver fat content (LFC) in individuals with metabolic dysfunction-associated steatotic liver disease (MASLD).

METHODS:

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.

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 ; Suschak, John J ; Parkes, David

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.

News (Medical) associated with Pemvidutide

07 Nov 2024

·www.globenewswire.com

Altimmune Announces Successful Completion of End-of-Phase 2 Meeting with FDA for Pemvidutide in the Treatment of Obesity

Company and Agency aligned on key efficacy and safety measures to be studied in Phase 3 program Pivotal Phase 3 trials designed to leverage the differentiated attributes of pemvidutide and potential benefits of balanced GLP-1/glucagon dual agonism GAITHERSBURG, Md., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and agreement on the design of a Phase 3 registrational program for its product candidate, pemvidutide, in the treatment of obesity. “Our interactions with the FDA regarding the Phase 3 development program have been incredibly productive, and this regulatory alignment represents a major accomplishment for our team,” said Vipin K. Garg, Ph.D., Chief Executive Officer of Altimmune. “As the metabolic landscape continues to evolve, we believe that the ability of a drug to address both obesity and its underlying comorbidities will become increasingly important, and we are confident that this is where pemvidutide has an opportunity to excel. Achieving this regulatory milestone is especially important as we advance our partnering efforts, approach the data readout from our Phase 2b IMPACT Trial in MASH and prepare IND submissions for additional indications.” The interaction with the FDA included an extensive review of the preclinical and clinical data generated to date, including data from six completed clinical trials of pemvidutide. The planned registrational program will include four Phase 3, randomized, double-blind, placebo-controlled, parallel-group trials, each evaluating treatment with pemvidutide over a 60-week period. The Phase 3 program is expected to enroll approximately 5,000 subjects across the four trials. The safety and efficacy of pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg will be evaluated with the intention of obtaining approval for all three doses. The Phase 3 program is designed to leverage the key attributes of pemvidutide, including the effects of balanced GLP-1/glucagon dual agonism in subjects with overweight and obesity. VELOCITY-1: This trial will assess the effects of pemvidutide on body weight in patients with obesity or overweight without diabetes. Other endpoints will include reductions in waist circumference, serum lipids, and blood pressure.VELOCITY-2: This trial will assess the effects of pemvidutide on body weight and serum lipids in subjects with obesity or overweight and elevated LDL cholesterol levels. The study population will include a subset of subjects with elevated LDL cholesterol levels despite ongoing statin therapy. A large proportion of patients taking statins fail to achieve target LDL levels, and in a previous Phase 2 clinical trial in subjects with overweight or obesity, pemvidutide appeared to enhance LDL-lowering effects in subjects receiving concomitant statin therapy.VELOCITY-3: This trial will assess the effects of pemvidutide on body weight in subjects with obesity or overweight and elevated liver fat. Excess liver fat is highly prevalent in patients with obesity and is associated with an increased risk of cardiovascular disease.VELOCITY-4: This trial will assess the effects of pemvidutide on body weight and body composition, including in an elderly population, with emphasis on individuals entering the study with sarcopenia at baseline. Functional measures and activities of daily living will also be assessed in this patient population. Scott Harris, M.D., Chief Medical Officer of Altimmune added, “We are pleased with the successful outcome of the End-of-Phase 2 meeting with the FDA. We continue to believe that pemvidutide is highly differentiated from other incretin-based agents currently available and in development. The Phase 3 obesity program is designed to maximize the unique attributes of pemvidutide beyond weight loss, including its potential for lipid lowering effects, liver fat reduction and lean mass preservation.” About PemvidutidePemvidutide 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 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 Forward-Looking StatementAny statements made in this press release related to the development or commercialization of product candidates and other business matters, including without limitation, the timing of key milestones for our clinical assets, and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company’s business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K and our other filings with the SEC, which are available at www.sec.gov. Company Contact:Vipin GargPresident and Chief Executive OfficerPhone: 240-654-1450ir@altimmune.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Julia WeilmanBurns McClellanPhone: 646-732-4443jweilman@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 2Phase 3Fast Track

30 Sep 2024

·www.globenewswire.com

Altimmune Completes Enrollment in Phase 2b IMPACT Trial of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH)

IMPACT trial is evaluating the safety and efficacy of pemvidutide in approximately 190 subjects with MASH; top-line efficacy data expected in Q2 2025 End-of-Phase 2 Meeting for the obesity program with U.S. Food and Drug Administration (FDA) has been scheduled for early November 2024 Company plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications beginning in Q4 2024 GAITHERSBURG, Md., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced completion of patient enrollment in IMPACT, its Phase 2b biopsy-driven trial evaluating pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) and provided an update on additional development and regulatory initiatives related to pemvidutide. “We continue to make important advancements in the development of pemvidutide and are excited to have completed enrollment in the IMPACT trial, with top-line efficacy data expected in the second quarter of 2025,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “We are also excited to have received FDA confirmation of the End-of-Phase 2 meeting for our obesity program, which is scheduled for early November. Furthermore, we are planning to file INDs for Phase 2 studies of pemvidutide in up to three additional indications. These initiatives are expected to expand the differentiation of pemvidutide in the metabolic disease space and enhance its long-term value proposition.” “IMPACT will be the first incretin-based study to read out on a biopsy-driven fibrosis endpoint at only 24 weeks. I believe the combination of direct liver effects and weight loss conferred by pemvidutide offers an important advantage over other approaches to the treatment of MASH and I look forward to the results of the IMPACT trial with great optimism,” said Dr. Mazen Noureddin, M.D., MHSc, Professor of Medicine at Houston Methodist Hospital, Director, Houston Research Institute and Principal Investigator on the IMPACT trial. “We look forward to aligning with the FDA on our Phase 3 clinical development plan for pemvidutide in obesity at our End-of-Phase 2 meeting in early November,” added Dr. Garg. “Our proposed registrational program leverages the unique attributes of pemvidutide, which we believe will benefit patients with obesity, excess liver fat and elevated serum lipids while preserving lean mass.” Altimmune also expects to file IND applications for pemvidutide in up to three additional indications with the first of these IND submissions in Q4 2024. The company plans to disclose details on these indications following alignment with the FDA. Preparations for the first trial are underway, with initiation planned for H1 2025. “We believe we have strong scientific rationale to support the development of pemvidutide in these additional indications, all of which are areas of high unmet medical need, where we believe its balanced GLP-1/glucagon dual agonism could allow for differentiation from other approaches,” said Scott Harris, M.D., Chief Medical Officer of Altimmune. About PemvidutidePemvidutide 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, robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure, while preserving lean mass. 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 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 Forward-Looking StatementAny statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of the IMPACT trial data readout, the timing of the planned End-of-Phase 2 FDA meeting, the timing of the planned IND submissions for pemvidutide, the timing of key milestones for any of our clinical assets, and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K and our other filings with the SEC, which are available at www.sec.gov. Company Contact:Vipin GargPresident and Chief Executive OfficerPhone: 240-654-1450ir@altimmune.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com Investor Contacts:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Julia WeilmanBurns McClellanPhone: 646-732-4443jweilman@burnsmc.com This press release was published by a CLEAR® Verified individual.

Phase 2Fast Track

10 Sep 2024

·www.globenewswire.com

Altimmune Presents Results of a Phase 2 MRI-Based Body Composition Sub-Study at 60th Annual Meeting of the European Association for the Study of Diabetes

Lean Loss Ratio of only 21.9%, representing class-leading preservation of lean mass Maintenance of lean mass preservation in individuals over the age of 60, a population at risk for frailty-related falls and fractures Visceral adipose tissue (VAT), a risk factor for cardiovascular disease, reduced by 25.6% at Week 48 GAITHERSBURG, Md., Sept. 10, 2024 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today presented data from its Phase 2, MRI-based body composition sub-study of pemvidutide in subjects with overweight and obesity at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain. Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and metabolic dysfunction-associated steatohepatitis (MASH). In an MRI sub-study of 67 subjects from the Phase 2 MOMENTUM obesity trial, 50 of whom were treated with pemvidutide for 48 weeks, the lean loss ratio, defined as the change in lean mass compared to the change in total mass, was 21.9%. Lean mass preservation was greater in subjects aged 60 years and older, in whom the lean loss ratio was only 19.9%. In addition to lean mass preservation, there was a preferential reduction of VAT, the adipose tissue associated with cardiovascular risk. At the 2.4mg dose of pemvidutide, VAT was reduced by 25.6% at Week 48 compared to a 20.1% loss in subcutaneous adipose tissue. “Preservation of lean mass may reduce risk of falls and fractures, development of co-morbidities, and rates of all-cause mortality, particularly in individuals over the age of 60,” said Scott Harris, M.D., Chief Medical Officer of Altimmune. “Given the breadth and diversity of the obesity patient population, there has been growing attention given to the quality of weight loss. Our data demonstrates pemvidutide’s class-leading lean mass preservation, superior to that reported historically with diet and exercise. The robust reductions in VAT would also be expected to be associated with a lower risk of cardiovascular disease.” About PemvidutidePemvidutide 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, 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 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 Forward-Looking StatementAny statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the timing of key milestones for our clinical assets, and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Company’s most recent annual report on Form 10-K and our other filings with the SEC, which are available at www.sec.gov. Company Contact:Vipin GargPresident and Chief Executive OfficerPhone: 240-654-1450ir@altimmune.com Media Contact:Danielle CanteyInizio Evoke, BiotechPhone: 619-826-4657Danielle.cantey@inizioevoke.com Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@burnsmc.com Julia WeilmanBurns McClellanPhone: 646-732-4443jweilman@burnsmc.com

Phase 2Fast TrackClinical Result

100 Deals associated with Pemvidutide

R&D Status

10 top R&D records.

to view more data

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.	01 Apr 2022
Diabetes Mellitus, Type 2	Phase 1	US	Altimmune, Inc.	01 Feb 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05292911 (GlobeNewswire) Manual	Phase 2	Obesity	67	Pemvidutide	yeoxtddlhn(ffwrdfoixa) = lkcadkgher bxpxarzfmf (exagzkpneg ) 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)	mecpgmoxmx(hxehlpyhro) = qnbjwktldj qqxzatsvot (ryvtbvcgxa, qrvzqohkkm - rgtzypxkrc) View more	-	19 Jul 2024
				Gemcitabine+ALT-801 (0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine)	mecpgmoxmx(hxehlpyhro) = zphxeylqpe qqxzatsvot (ryvtbvcgxa, zfwduxhukp - kvyqzpbqtu) View more
NCT05006885 (Pubmed) Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus (T2DM)	94	Pemvidutide 1.2 mg	dnhhcefskk(rbdnjisdsh) = mdfjfbxkjo svdwoenejc (keqhzimlsa, -63.7 to -29.6)	Positive	01 Jul 2024
				Pemvidutide 1.8 mg	dnhhcefskk(rbdnjisdsh) = pcsuimvezv svdwoenejc (keqhzimlsa, -84.4 to -52.5) View more
MOMENTUM (GlobeNewswire) Manual	Phase 2	Obesity	391	Pemvidutide 1.2 mg	eoyapfdyxp(cxvngisyyr) = etiwxhlmwu jwcopaiggl (xcnhpwbbxg )	Positive	23 Jun 2024
				Pemvidutide 1.8 mg	eoyapfdyxp(cxvngisyyr) = zuyvpaelvh jwcopaiggl (xcnhpwbbxg )
ADA2024	Not Applicable	Overweight	-	Pemvidutide 1.2 mg	tkkfkrswul(xnxbijqumh) = 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 ncncalqdeh (lzqtckkngc )	-	23 Jun 2024
				Pemvidutide 1.8 mg
NCT01670994 (CTgov)	Phase 1/2	Relapse multiple myeloma \| Plasma cell myeloma refractory	6	ALT-801 (ALT-801 0.04mg/kg)	xofobzyfct(cfyiadqery) = tgtjracpca tlelwdqjwj (czmvrrojaz, chbczjkhaw - mhddqmzzlm) View more	-	18 Jun 2024
				ALT-801 (ALT-801 0.06mg/kg)	xofobzyfct(cfyiadqery) = hstiofcoxz tlelwdqjwj (czmvrrojaz, akrrzoyihx - wiqhyoqdye) View more
ADA2024	Not Applicable	Lipid Metabolism Disorders	-	Pemvidutide 1.2 mg	cintaotwcl(iewvirpacn) = Reduction in GlycA, biomarker of systemic inflammation correlated with heart failure, were also observed wekfcvyynn (dwdyzcffgb ) View more	-	14 Jun 2024
				Pemvidutide 1.8 mg
MOMENTUM (NEWS) Manual	Phase 2	Obesity \| Overweight	391	pemvidutide 1.2mg	wewxjgkujv(dqtfyocywg) = brgszmkxsx qsvrqvgzcc (wsmzlksdlw, 1.4) View more	Positive	02 Dec 2023
				pemvidutide 1.8mg	wewxjgkujv(dqtfyocywg) = gvcjlyjjma qsvrqvgzcc (wsmzlksdlw, 1.4) View more
NCT05292911 (Corporate Publications) Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease	64	Pemvidutide 1.2mg	ubnybblony(sklauvihut) = zxtrjwshtr dolzmejecw (mfxzfhmbqm ) View more	Positive	13 Nov 2023
				Pemvidutide 1.8mg	ubnybblony(sklauvihut) = lfbounurdg dolzmejecw (mfxzfhmbqm ) View more
NEWS Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease	94	placebo	khxlggsolu(gwbxvjnfmw) = fsmzkclfrt gfpqltslka (vlugppuwbx ) View more	Positive	25 Oct 2023
				pemvidutide 1.2 mg	khxlggsolu(gwbxvjnfmw) = fldoyotpke gfpqltslka (vlugppuwbx ) View more

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