Altimmune Completes Enrollment in Phase 2b IMPACT Trial of Pemvidutide in Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Altimmune (Nasdaq: ALT) has completed enrollment in its Phase 2b IMPACT trial, evaluating pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH). The trial includes approximately 190 subjects, with top-line efficacy data expected in Q2 2025. An End-of-Phase 2 Meeting with the FDA for the obesity program is scheduled for early November 2024.
The company plans to submit Investigational New Drug (IND) applications for pemvidutide in up to three additional indications starting in Q4 2024. Altimmune aims to expand pemvidutide's differentiation in the metabolic disease space and enhance its long-term value proposition. The IMPACT trial is notable as the first incretin-based study to evaluate a biopsy-driven fibrosis endpoint at 24 weeks.
Altimmune (Nasdaq: ALT) ha completato l'arruolamento nel suo studio di Fase 2b IMPACT, che valuta il pemvidutide per la steatoepatite associata a disfunzione metabolica (MASH). Lo studio include circa 190 soggetti, con dati di efficacia preliminari attesi per il Q2 2025. Un incontro di fine fase 2 con la FDA per il programma sull'obesità è previsto per all'inizio di novembre 2024.
L'azienda prevede di presentare domande di nuovo farmaco sperimentale (IND) per il pemvidutide in fino a tre ulteriori indicazioni a partire dal Q4 2024. Altimmune mira ad espandere la differenziazione del pemvidutide nel campo delle malattie metaboliche e a migliorare la sua proposta di valore a lungo termine. Lo studio IMPACT è significativo poiché è il primo studio basato su incretine a valutare un endpoint di fibrosi guidato da biopsia a 24 settimane.
Altimmune (Nasdaq: ALT) ha completado la inscripción en su ensayo de Fase 2b IMPACT, que evalúa el pemvidutide para la esteatohepatitis asociada a disfunción metabólica (MASH). El ensayo incluye aproximadamente 190 sujetos, con datos de efectividad preliminares esperados en el Q2 2025. Una reunión de fin de Fase 2 con la FDA para el programa de obesidad está programada para principios de noviembre de 2024.
La compañía planea presentar solicitudes de nuevo fármaco en investigación (IND) para el pemvidutide en hasta tres indicaciones adicionales comenzando en el Q4 2024. Altimmune tiene como objetivo expandir la diferenciación del pemvidutide en el espacio de enfermedades metabólicas y mejorar su propuesta de valor a largo plazo. El ensayo IMPACT es notable porque es el primer estudio basado en incretinas que evalúa un punto final de fibrosis guiado por biopsia a 24 semanas.
Altimmune (Nasdaq: ALT)는 대사 기능 장애와 관련된 지방간염(MASH)에 대한 펨비듀타이드 평가를 위한 2b상 IMPACT 시험에 등록을 완료했습니다. 이 시험에는 약 190명의 피험자가 포함되어 있으며, 최종 효능 데이터는 2025년 2분기(Q2)에 공개될 예정입니다. 비만 프로그램을 위한 FDA의 2단계 종료 미팅은 2024년 11월 초로 예정되어 있습니다.
회사는 2024년 4분기(Q4)부터 시작하여 펨비듀타이드에 대한 최대 3개의 추가 적응증에 대한 신약 임상 시험(IND) 신청서를 제출할 계획입니다. Altimmune은 대사 질환 분야에서 펨비듀타이드의 차별성을 확장하고 그것의 장기적인 가치 제안을 강화하는 것을 목표로 하고 있습니다. IMPACT 시험은 24주 동안의 생검 기반 섬유증 최종점을 평가하는 첫 번째 인크레틴 기반 연구로 주목받고 있습니다.
Altimmune (Nasdaq: ALT) a terminé l'enrôlement dans son essai de phase 2b IMPACT, évaluant le pemvidutide pour la stéatohépatite associée à des dysfonctionnements métaboliques (MASH). L'essai inclut environ 190 sujets, avec des données d'efficacité préliminaires attendues pour le 2ème trimestre 2025. Une réunion de fin de phase 2 avec la FDA pour le programme d'obésité est prévue pour début novembre 2024.
L'entreprise prévoit de soumettre des demandes de nouveau médicament expérimental (IND) pour le pemvidutide dans jusqu'à trois indications supplémentaires à partir du 4ème trimestre 2024. Altimmune vise à élargir la différenciation du pemvidutide dans le domaine des maladies métaboliques et à renforcer sa proposition de valeur à long terme. L'essai IMPACT est notable car il s'agit de la première étude basée sur les incrétines à évaluer un critère de jugement de fibrose guidé par biopsie à 24 semaines.
Altimmune (Nasdaq: ALT) hat die Einschreibung in seine Phase-2b-Studie IMPACT abgeschlossen, die Pemvidutid zur Behandlung der metabolisch assoziierten Steatohepatitis (MASH) evaluiert. Die Studie umfasst etwa 190 Probanden, wobei erste Wirksamkeitsdaten für das 2. Quartal 2025 erwartet werden. Ein Ende-der-Phase-2-Treffen mit der FDA für das Adipositasprogramm ist für Anfang November 2024 geplant.
Das Unternehmen plant, Investigational New Drug (IND)-Anträge für Pemvidutid in bis zu drei zusätzlichen Indikationen ab dem 4. Quartal 2024 einzureichen. Altimmune hat zum Ziel, die Differenzierung von Pemvidutid im Bereich der Stoffwechselerkrankungen auszubauen und sein langfristiges Wertversprechen zu verbessern. Die IMPACT-Studie ist bemerkenswert, da sie die erste inkretinbasierte Studie ist, die einen bioptisch gesteuerten Fibrose-Endpunkt nach 24 Wochen evaluiert.
- Completed enrollment in Phase 2b IMPACT trial for MASH
- End-of-Phase 2 Meeting with FDA scheduled for obesity program
- Plans to submit INDs for up to three additional indications
- IMPACT trial is first to evaluate biopsy-driven fibrosis endpoint at 24 weeks for incretin-based therapy
- None.
Insights
The completion of enrollment in Altimmune's Phase 2b IMPACT trial for pemvidutide in MASH is a significant milestone. This trial, evaluating approximately 190 subjects, aims to be the first incretin-based study to report on a biopsy-driven fibrosis endpoint at just 24 weeks. The combination of direct liver effects and weight loss from pemvidutide could potentially offer an advantage over existing MASH treatments.
Key points to consider:
- Top-line efficacy data expected in Q2 2025
- End-of-Phase 2 meeting with FDA for obesity program scheduled for early November 2024
- Plans to submit INDs for up to three additional indications starting Q4 2024
- First trial in new indication planned to initiate in H1 2025
The expansion into multiple indications could significantly broaden pemvidutide's market potential and differentiate it in the competitive metabolic disease space. However, investors should note that positive results are not guaranteed and the timeline for potential commercialization extends well into the future.
Altimmune's progress with pemvidutide presents several potential value drivers for investors to monitor:
- Diversification of pipeline: Expansion into multiple indications reduces risk and increases potential market opportunities.
- Regulatory milestones: The upcoming End-of-Phase 2 meeting for obesity and planned IND submissions are critical for advancing the development timeline.
- Data catalysts: Top-line efficacy data from the IMPACT trial in Q2 2025 will be a significant event for assessing pemvidutide's potential in MASH.
With a market cap of
The expansion into new indications also increases the potential for partnerships or licensing deals, which could provide additional non-dilutive funding. Overall, this news positions Altimmune for potential growth but carries the inherent risks associated with clinical-stage biotech companies.
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 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, 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 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 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 Garg
President and Chief Executive Officer
Phone: 240-654-1450
ir@altimmune.com
Media Contact:
Danielle Cantey
Inizio Evoke, Biotech
Phone: 619-826-4657
Danielle.cantey@inizioevoke.com
Investor Contacts:
Lee Roth
Burns McClellan
Phone: 646-382-3403
lroth@burnsmc.com
Julia Weilman
Burns McClellan
Phone: 646-732-4443
jweilman@burnsmc.com
This press release was published by a CLEAR® Verified individual.
FAQ
When will Altimmune (ALT) release top-line efficacy data for the IMPACT trial?
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When does Altimmune (ALT) plan to submit the first IND application for pemvidutide in additional indications?
