Altimmune Announces Successful Completion of End-of-Phase 2 Meeting with FDA for Pemvidutide in the Treatment of Obesity
Altimmune (Nasdaq: ALT) announced successful completion of End-of-Phase 2 Meeting with FDA for pemvidutide in obesity treatment. The company received agreement on Phase 3 registrational program design, which will include four Phase 3 trials (VELOCITY-1,2,3,4) enrolling approximately 5,000 subjects over 60-week periods. The trials will evaluate pemvidutide doses of 1.2 mg, 1.8 mg, and 2.4 mg, focusing on different patient populations including those with elevated LDL cholesterol, elevated liver fat, and elderly with sarcopenia. The program aims to leverage pemvidutide's balanced GLP-1/glucagon dual agonism benefits.
Altimmune (Nasdaq: ALT) ha annunciato il completamento con successo dell'incontro di fine fase 2 con la FDA per il pemvidutide nel trattamento dell'obesità. L'azienda ha ricevuto l'accordo sul design del programma registrativo di fase 3, che includerà quattro prove di fase 3 (VELOCITY-1, 2, 3, 4) con l'arruolamento di circa 5.000 soggetti nel corso di un periodo di 60 settimane. Le prove valuteranno dosi di pemvidutide di 1,2 mg, 1,8 mg e 2,4 mg, concentrandosi su diverse popolazioni di pazienti, inclusi quelli con elevati livelli di colesterolo LDL, elevata percentuale di grasso epatico e gli anziani con sarcopenia. Il programma mira a sfruttare i benefici dell'agonismo duale bilanciato di GLP-1/glucagone del pemvidutide.
Altimmune (Nasdaq: ALT) anunció la finalización exitosa de la reunión de fin de fase 2 con la FDA para el pemvidutide en el tratamiento de la obesidad. La compañía recibió un acuerdo sobre el diseño del programa de registro de fase 3, que incluirá cuatro ensayos de fase 3 (VELOCITY-1, 2, 3, 4) con aproximadamente 5,000 sujetos en periodos de 60 semanas. Los ensayos evaluarán dosis de pemvidutide de 1.2 mg, 1.8 mg y 2.4 mg, centrándose en diferentes poblaciones de pacientes, incluidos aquellos con colesterol LDL elevado, grasa hepática elevada y ancianos con sarcopenia. El programa busca aprovechar los beneficios del agonismo dual equilibrado de GLP-1/glucagón del pemvidutide.
Altimmune (Nasdaq: ALT)는 비만 치료를 위한 pemvidutide와 관련하여 FDA와의 2단계 종료 회의가 성공적으로 완료되었음을 발표했습니다. 회사는 약 5,000명의 피험자를 60주 동안 모집하는 4개의 3상 시험 (VELOCITY-1, 2, 3, 4)에 대한 등록 프로그램 설계에 대한 합의를 받았습니다. 이 시험들은 LDL 콜레스테롤 수치가 높은 환자, 간 지방이 높은 환자, 그리고 근감소증이 있는 노인을 포함한 다양한 환자 집단을 대상으로 pemvidutide의 1.2 mg, 1.8 mg 및 2.4 mg 용량을 평가할 것입니다. 이 프로그램은 pemvidutide의 균형 잡힌 GLP-1/글루카곤 이중 작용의 이점을 활용하는 것을 목표로 합니다.
Altimmune (Nasdaq: ALT) a annoncé l'achèvement réussi de sa réunion de fin de phase 2 avec la FDA concernant le pemvidutide pour le traitement de l'obésité. L'entreprise a obtenu un accord sur la conception du programme d'enregistrement de phase 3, qui comprendra quatre essais de phase 3 (VELOCITY-1, 2, 3, 4) avec environ 5 000 participants sur une période de 60 semaines. Les essais évalueront des doses de pemvidutide de 1,2 mg, 1,8 mg et 2,4 mg, en se concentrant sur différentes populations de patients, notamment ceux présentant un taux élevé de cholestérol LDL, une graisse hépatique élevée et les personnes âgées atteintes de sarcopénie. Le programme vise à tirer parti des avantages de l'agonisme dual équilibré GLP-1/glucagon du pemvidutide.
Altimmune (Nasdaq: ALT) gab die erfolgreiche Durchführung des End-of-Phase-2-Meetings mit der FDA für Pemvidutide zur Behandlung von Fettleibigkeit bekannt. Das Unternehmen erhielt die Zustimmung zum Design des Phase-3-Registrierungsprogramms, das vier Phase-3-Studien (VELOCITY-1, 2, 3, 4) umfassen wird und etwa 5.000 Teilnehmer über einen Zeitraum von 60 Wochen einschließen soll. Die Studien werden Dosen von Pemvidutide von 1,2 mg, 1,8 mg und 2,4 mg untersuchen und sich auf verschiedene Patientengruppen konzentrieren, darunter diejenigen mit erhöhtem LDL-Cholesterin, erhöhtem Leberfett und ältere Menschen mit Sarkopenie. Das Programm zielt darauf ab, die Vorteile der ausgewogenen GLP-1/Glukagon-Dual-Agonismus von Pemvidutide zu nutzen.
- FDA agreement on Phase 3 program design indicates regulatory alignment
- Comprehensive Phase 3 program with 5,000 subjects across four trials
- Multiple dose options (1.2mg, 1.8mg, 2.4mg) being evaluated for approval
- Previous Phase 2 trial showed enhanced LDL-lowering effects with statin therapy
- Large-scale Phase 3 program with 5,000 subjects implies significant costs
- Extended 60-week trial duration suggests lengthy time to potential approval
Insights
The successful End-of-Phase 2 meeting with FDA marks a significant milestone for Altimmune's pemvidutide obesity program. The comprehensive Phase 3 program, involving 4 trials with ~5,000 subjects, is strategically designed to demonstrate pemvidutide's differentiated profile as a GLP-1/glucagon dual agonist.
The trial design is particularly noteworthy for targeting multiple high-value indications:
- VELOCITY-1 focuses on general obesity
- VELOCITY-2 addresses lipid management, especially in statin-treated patients
- VELOCITY-3 targets liver fat reduction
- VELOCITY-4 examines body composition and sarcopenia
This regulatory milestone significantly de-risks Altimmune's development pathway for pemvidutide. The comprehensive Phase 3 program, while requiring substantial investment, positions the company to potentially capture multiple valuable market segments within the rapidly expanding obesity treatment landscape. The timing is strategic as Altimmune advances partnering discussions and approaches data readout from the MASH trial.
The market opportunity is substantial, with current obesity therapeutics generating multi-billion dollar revenues. Pemvidutide's differentiated profile, particularly its dual mechanism targeting both weight loss and metabolic improvements, could provide competitive advantages in this lucrative market. The successful FDA meeting may also enhance Altimmune's position in partnership negotiations, potentially leading to valuable collaboration opportunities.
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 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.
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Forward-Looking Statement
Any 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 Garg
President and Chief Executive Officer
Phone: 240-654-1450
ir@altimmune.com
Investor Contact:
Lee Roth
Burns McClellan
Phone: 646-382-3403
lroth@burnsmc.com
Julia Weilman
Burns McClellan
Phone: 646-732-4443
jweilman@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.
FAQ
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